Académique Documents
Professionnel Documents
Culture Documents
DN-------Delivery Note
HF--------Health facility
RV--------Receiving voucher
Container
The material employed in the packaging of a pharmaceutical product. Containers include
primary, secondary and transportation containers. Containers are referred to as primary if they
are intended to be in direct contact with the product. Secondary containers are not intended to
be in direct contact with the product.
Distribution
The division and movement of pharmaceutical products from the premises of the manufacturer
of such products, or another central point, to the end user thereof, or to an intermediate point
by means of various transport methods, via various storage and/or health establishments.
Expiry date
The date given on the individual container (usually on the label) of a product up to and
including which the product is expected to remain within specifications, if stored correctly. It is
established for each batch by adding the shelf-life to the date of manufacture.
Labeling
Process of identifying a pharmaceutical product including the following information, as
appropriate: name; active ingredient(s), type and amount; batch number; expiry date; special
storage conditions or handling precautions; directions for use, warnings and precautions;
names and addresses of the manufacturer and/or the supplier
Pharmaceutical product
Any medicine intended for human use or veterinary product administered to food-producing
animals, presented in its finished dosage form, which is subject to control by pharmaceutical
legislation in both the exporting state and the importing state (adapted from GMP).
Product recall
Product recall is a process for withdrawing or removing a pharmaceutical product from the
pharmaceutical distribution chain because of defects in the product or complaints of serious
adverse reactions to the product. The recall might be initiated by the manufacturer, importer,
distributor or a responsible agency.
Quality assurance
Quality assurance is a wide-ranging concept covering all matters that individually or collectively
influence the quality of a product. It is the totality of the arrangements made with the object of
ensuring that pharmaceutical products are of the quality required for their intended use.
Quality control
Quality control covers all measures taken, including the setting of specifications, sampling,
testing and analytical clearance, to ensure that starting materials, intermediates, packaging
materials and finished pharmaceutical products conform with established specifications for
identity, strength, purity and other characteristics.
Quarantine
The status of pharmaceutical products isolated physically or by other effective means while a
decision is awaited on their release, rejection or reprocessing (adapted from GMP).
Shelf-life
The period of time during which a pharmaceutical product, if stored correctly, is expected to
comply with the specification as determined by stability studies on a number of batches of the
product. The shelf-life is used to establish the expiry date of each batch.
Standard operating procedure (SOP)
An authorized, written procedure giving instructions for performing operations not necessarily
specific to a given product but of a more general nature
(e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and
environmental control, sampling and inspection). Certain SOPs may be used to supplement
product-specific master and batch production documentation.
Storage
The storing of pharmaceutical products up to the point of use
Supplier
Person or company providing pharmaceutical products on request. Suppliers include
distributors, manufacturers or traders.
Transit
The period during which pharmaceutical products are in the process of being carried, conveyed,
or transported across, over or through a passage or route to reach the destination.
Validation
Action of proving and documenting that any process, procedure or method actually and
consistently leads to the expected results.
Vehicle
Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats
and other means which are used to convey pharmaceutical products.
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Recording of new arrivals is an important activity to clarify for any interested body of what kind and
quantities items received by the warehouse and the time of receipt. It also makes it easier for the follow
up of preparation of receiving vouchers.
2. Purpose
To facilitate the preparation of receiving voucher for newly arrived items.
To have full record of issues related to the new arrival ( time of arrival, Carrier’s or driver’s name,
number of cartons or pallets delivered)
To identify place of receipt/warehouse
3. Scope
This SOP is used at the time of receiving of new items from any source (Supplier, Central or branch
warehouses).
4. Responsibilities
Title Responsibility
Storage and Distribution officer
New arrival
Yes
No
6.1 The Receiving Store Keeper receives bill of lading/AWB, packing list, invoice, or other freight documents
from driver/transistor/ carrier.
6.2 Warehouse Manager arrange warehouse space before the arrival of items
6.3 Items are unloaded at receiving area. While unloading, isolate a different pack (damaged, loose pack)
and place separately.
6.4 Driver and the Receiving Store Keeper verify the quantities against the bill of lading, invoice, etc. If there
are no variation the Receiving Store Keeper will sign the delivery document/invoices.
6.5 When a discrepancy exists, the Receiving Store Keeper and Storage & Distribution Officer will verify
whether the driver/carrier is accountable or not. If the driver is accountable, a discrepancy verification
report is filled in and an appropriate measure will be taken.
6.6 The Receiving Store Keeper enters the particulars of the received items in the format “Record of
Incoming Goods” and signs for approval of receipt. The particulars of “Record of Incoming Goods” are
mentioned in the format. Record of Incoming Goods is prepared in triplets immediately (Annex 1).
6.7 A copy of Record of Incoming Goods is given to the driver/deliverer if requested.
6.8 A copy of the format should be given to Stock and Distribution and Procurement Directorates.
7. Amendment History
Date:
1. Introduction/background
Physical inspection is the inspection which is performed on the newly received item after handover is
completed between the driver/carrier and the receiving store keeper. For branch warehouses and local
suppliers physical inspection will be performed before handover is completed.
2. Purpose
To identify missing quantities and items.
To separate damaged items from sound ones.
To indicate damage and missing quantities in receiving vouchers
To separate items by their expiry date and batch number and make a record on goods receiving
voucher accordingly
To ensure products are delivered according to the contract document and sample submitted.
To identify items which are not mentioned in supply list if any.
3. Scope
This SOP is used after a product is received from a supplier at central or branch warehouses and before a
receiving voucher is prepared.
4. Responsibilities.
Title Responsibility
Storage and Distribution Officer Get copies of invoices and packing lists of newly received items and
conduct physical inspection with warehouse manager
Warehouse Manager Notify responsible transit worker the result of the inspection in terms
of quantity.
Record any missing and damaged quantities in the invoices and send
too store clerk for preparation of receiving voucher
Warehouse Operative Arrange products on pallets according to batch number and expiry
date
5. Process map/Flowcharts
Start
Local
Send the invoice and packing list to store
Source clerk for preparation of receiving voucher
Foreign
Physical inspection for local or central PFSA shipment should be done within 30 minutes. For foreign products it
must be performed within 48 hours.
6.1 The store keeper should get copies of invoices and packing lists of newly received items. The packing lists
describe whether there are "Loose cartons".
6.2 Conduct preliminary physical inspection by using a check list (attached as annex 2).
6.3 Arrange the items on pallets or other location according to the expiry and batch number. Use the packing list
for easy reference of batch number and expiry dates.
6.4 Look for damaged/defective packages while arranging and open the packages to separate the damaged from
the good ones.
6.5 Put damaged items in separate place.
6.6 Put “Loose cartons ‘’ in separate place.
6.7 Calculate total quantities of the usable and damaged items. Do not forget to account for "Loose cartons".
6.8 Verify the figure in 6.7 against invoice quantity and check whether there is a difference in received quantity
and invoiced quantity by filling a discrepancy report, if any.
6.9 Notify responsible transit worker the result of the inspection in terms of type and quantity.
6.10 By referring the Record of Incoming Goods, bill of lading, invoice, packing list etc, the transistor will verify the
correctness of the inspection in terms of quantity and issues a formal transit transfer voucher to the receiving
storekeeper. The transfer voucher indicates the missing quantities and other relevant remarks. Copy of
transfer voucher is attached to this SOP (annex 3).
6.11 Missing and damaged quantities are then described in the invoices by the receiving storekeeper; the invoices
together with packing lists are sent to the store clerk for the preparation of receiving voucher.
6.12 If the item received is from local source where there is no need for transit involvement, the receiving
storekeeper sends the invoice and packing list with appropriate remark to the store clerk for preparation of
receiving voucher.
7. Amendment History
Date:
1. Introduction/background
Once physical inspection and arrangement of newly arrived items is completed, the items must be recorded in
Good Receiving Voucher. Receiving Vouchers are of two types:
Goods receiving voucher, this is used to record the receipts of new arrivals the source of which is a foreign
supplier or a local supplier.
Inter organizational Goods Receiving Voucher: this is used to record receipts from the agency
warehouses. The steps involved for both recordings are the same.
2. Purpose
To record usable, short landed and damaged quantities of newly received items.
3. Scope
This SOP is used after physical inspection and arrangement of items by batch number and expiry date is
completed; and when the item source is foreign a transit transfer voucher is issued.
4. Responsibilities.
Title Responsibility
Storage and Distribution Officer Approving the GRV
Warehouse Manager Providing relevant documents and information
Store clerk recording of the receiving voucher
5. Process map/Flowcharts
Start
Note: The format for “Goods Receiving Voucher ‘’ and “Inter organizational Goods Receiving Voucher ’’ is attached
to this SOP (annex 4 and 5 respectively).
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
After a receiving voucher is prepared for newly received items ( and after a QC approval is obtained when
applicable) , the items have to be moved to storage area and put away appropriately by following good storage
practice. Depending on whether the receiving and storage warehouses are managed by same or different
responsible person/s, the need for an inter-store transfer voucher is decided. If the same person handles the
management of both warehouses, there is no need for issue of an inter-store transfer voucher. However, if the
receiving warehouse and storage warehouse are managed by different persons then an inter-store transfer
voucher is mandatory.
2. Purpose
To place items on their preferred location.
To follow good storage practice.
3. Scope
This SOP is used after the completion of the preparation of receiving voucher and when the movement of the
items from receiving to storage area is required.
4. Responsibilities
Title Responsibility
Warehouse Manager Confirm quantities transferred from receiving to storage area.
Warehouse operatives Placing products in their preferred location
5. Process map/Flowcharts
Start
Yes
Note: The format for “Inter –Store Transfer Voucher” is attached to this SOP (annex 6).
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Transfer of items between stores of a central or branch warehouses occur for various reasons. Some of which are:
When there is shortage of space in one of the stores and wider space in the other,
To facilitate customer service. When there is an overload of work in one of the stores, the service can be
made more efficient by transferring the items to another store and make the customer being served
there.
2. Purpose
To efficiently utilize storage space
To enhance customer service
3. Scope
This SOP is used to transfer items between stores within central warehouses and branch warehouses.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Receive transfer request and prepare issue order for items to be
transferred
Warehouse Manager Prepare Inter-store transfer voucher by referring to the issue order
Arrange warehouse space for incoming items
5. Process map/Flowcharts
Start
6.1 Receive transfer request/order for items to be transferred. The request for the transfer can be initiated by
receiver store, transferor store or the Storage and Distribution officer.
6.2 Issue order is prepared for items to be transferred
6.3 Inter store transfer voucher is prepared by referring to the issue order
6.4 Transferor store arranges items by batch and expiry based on ISTV.
6.5 Receiver store arrange storage space for the items
6.6 The items are moved from transferor to receiver store and put away to their specific locations.
6.7 The inter-store transfer voucher is signed by both the storekeepers.
6.8 Copies of the inter-store transfer voucher are distributed to finance; storage sections and Document follow up
clerk.
7 Amendment History
Date:
1. Introduction/background
For every newly received item a break down allocation to branches should be made at central level. To decide on
allocation of break down, the supply plan prepared by the forecasting team should be consulted with central and
branches.
2. Purpose
To allocate break down of new arrivals to branches.
To notify the break down to branches by letter, e-mail, fax, telephone or other communication
means.
3. Scope
This SOP is used after completion of the preparation of receiving voucher.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Preparation of distribution breakdown and communicating to
branches.
5. Process map/Flowcharts
Start
6.1 Get a copy of the Receiving Voucher (GRV/IGRV) and commercial invoice for the newly received item.
6.2 Refer to the Supply plan to get information on quantities allocated to each branch by forecasting team.
6.3 Check up current inventory, consumption and demand at each branch.
6.4 Prepare adjusted allocation break down of the new item for each branch (refer for the attached format
for allocation of break down). The Storage and Distribution Directorate Director or process owner should
be consulted whenever deemed necessary while preparing break down.
6.5 Communicate allocation break down to branches, Transport routing and scheduling.
6.6 Obtain feedback from branches related to allocation of break down and adjust as necessary.
7. Amendment History
Note: A format for allocation of break down is attached to this SOP (annex 7).
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Once the allocation of break down for branches is completed/or all requests from branches or SDPs received,
the next step would be to prepare issue order. Issue order is prepared for a particular branch in accordance
with the delivery schedule. The source for the preparation of issue order is the allocated breakdown to
branches or SDPs.
2. Purpose
This SOP is used to prepare issue order for items to be transferred to branches and SDPs.
3. Scope
This SOP is used at the time when items are to be transferred from central stores to branches and
SDPs.
4. Responsibilities
Title Responsibility
Storage and Distribution follow-up officer Preparation of issue order.
Storage and Distribution Officer Approving issue order
5. Process map/Flowcharts
Start
6.2. At the time of delivery to a particular branch issue order is prepared for the items to be delivered
to the branch by referring to the break down. Issue order is prepared in four copies
6.3. Make sure the quantities described on the issue order are of appropriate package convenient for
distribution. As much as it is possible original sealed cartons are preferred for issue.
6.4. Communicate issue order to storage warehouse and approximate volume/weight of the items to
routing and scheduling
6.5. The storage warehouse prepare pick slips from the issue order/ or utilize the issue order as pick slip
and fleet management unit arranges transport with General Service Directorate.
7. Amendment History
Note: A format for issue order should be attached to this SOP (annex 8).
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
After issue orders are communicated to storage warehouse for Items to be delivered to a branch/health facility, a
picking slip is prepared and given to warehouse operatives, for picking items from storage area and move them to
the dispatch area. Verification of the items picked against the picking slip is carried out on the dispatch area.
2. Purpose
This SOP is used to pick, dispatch and verify the right items, in the right quantity, right expiry, right batch
number, right manufacturer, from the right location of storage area.
3. Scope
This SOP is used at the time when items are to be transferred from central/branches stores to
branches/SDPs. It is also used when items are transferred between central and branch stores.
4. Responsibilities
Title Responsibility
Warehouse Manager Verification of items against the issue order and STV.
Dispatch officer Verification of items against the issue order and STV.
Warehouse operatives Picking and dispatching of pharmaceuticals
5. Process map/Flowcharts
Start
6.1 Prepare picking list from the issue order and hand over to the warehouse operatives.
6.2 Warehouse operatives pick items from the storage area as exactly mentioned on the picking slip or
issue order, including checking expiry dates and batch numbers.
6.3 Picked items are placed on dispatch area and arranged by category convenient for count.
6.4 Storekeeper counts the dispatch and verifies against picking slip/ issue order and sign on it the
picking slip.
6.5 Dispatch checker confirms the correctness of the dispatch count and sign on the picking slip.
6.6 Picking slip/issue order is then sent to store clerk for the preparation of STV/DN
7. Amendment History
Date:
1. Introduction/background
Handover of items to the driver/recipient is carried out after the STV/DN is prepared. The packing of loose cartons
is performed after the receiver counts the contents of the cartons.
2. Purpose
This SOP is used for packing, labeling and handing over of items to receiver with due diligence.
3. Scope
4. Responsibilities
Title Responsibility
Warehouse Manager and Handing over of items to receiver.
Dispatch officer Collect STV from store clerk and distribute to warehouses
Prepare get pass for driver/receiver
Warehouse operatives Packing, labeling and loading of cartons.
Driver/receiver Counting and verification with documents before signing for
approval of receipt.
Storage and Distribution Officer Notify the departure of truck to destined branch
5. Process map/Flowcharts
Start
Get the original and all copies of the STV /DN from
the store clerk
Vehicle departs
6.1. The store keeper should get original and all copies of the STV /DN from the store clerk.
6.2. The driver/receiver is called to dispatch area and given a copy of the STV/DN.
6.3. The driver/receiver counts the dispatched items and verifies against the STV/DN.
6.4. Loose cartons after being count and verified by driver/receiver are sealed right away.
6.5. The driver/receiver put his signature on the original and all copies of STV/DN for approval of
receipt.
6.6. The driver/receiver is given an original and a copy of the STV/DN to be submitted to the
destined branch and the items are loaded on the vehicle.
6.7. The driver collects gate pass from the store keeper and departs.
6.8. Storage and distribution officer should notify the departure of truck to destined branch.
7. Amendment History
Note: The formats for “Stock Transfer Voucher” and “Delivery Note” are attached to this SOP (annex 9 and 10).
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Handover of items from driver/deliverer to branch warehouses is carried out by counting the items
and verifying with the accompanying documents. Discrepancies (item discrepancy, overage and
shortage) should be described in the place located on the documents. Damages should be handled in
accordance with the PFSA distribution manual and in accordance with PFSA SOP no PSD/SOP/16)
2. Purpose
The purpose of this SOP is to facilitate handover of items from driver/deliverer to branch warehouses
with due diligence.
3. Scope
This SOP is used during hand over of items from driver/receiver to branch warehouses, the sender being
the central warehouse. It is also used during handover of items directly to PFSA branches from local
suppliers or manufacturers.
4. Responsibilities
Title Responsibility
Warehouse Manager Counting and verification with documents before signing for approval
of receipt.
Driver/deliverer Transfer the items to the receiving storekeeper by availing himself
when all items are unloaded, counted and verified with documents.
Warehouse operatives Arrange product during handover
Storage and Distribution Officer Confirm the delivery and discrepancies if any.
5. Process map/Flowcharts
Yes
6.1 On arrival at a branch, the driver/deliverer handover the two copies of STVs or delivery notes to the receiving
store keeper and unload the items.
6.2 The receiving storekeeper counts each item by description and verify with the quantities described on the STV
or delivery note.
6.3 If there are no discrepancies or defects between the count and STV/delivery note the receiving storekeeper
signs the original and copy of delivery documents for approval of receipt in good condition.
6.4 If there is missing or defect, same have to be mentioned on the appropriate place on the STV or delivery note
and be signed by both the receiving store keeper and the driver.
6.5 The driver/deliverer receives a signed and sealed copy of the STV and/ or delivery note.
6.6 The driver/deliverer submits copies to the Documentation Follow up Clerk of sender warehouse and collects a
receipt from the clerk for proof of delivery of the documents.
7 Amendment History
Note: The formats for “Discrepancy reporting format” and “Receipt for documents” (annex 11 and 12)” is
attached to this SOP.
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
The main categories of customers for RDF/program supplies are public health facilities. This procedure focuses on
the procedure for handling the request from public health facilities.
2. Purpose
To facilitate the process of handling of customer request
To ensure customer satisfaction.
3. Scope
This SOP is used when the requests of public health facilities are collected, processed and ready for delivery.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Handling customer request and preparation of issue order.
Store clerk Preparation of invoices for the items described on the issue order
5. Process map/Flowcharts
Start
.
Enter customer request in the system
Warehouse operatives pick items as they are Warehouse Manager and dispatch officer will verify
described in the issue order/pick list (bin dispatched items against the issue order/pick slip
location, description, unit, expiry date, batch and both sign on issue order/ pick slip.
number, and manufacturer).
If item is not found as described on the issue Warehouse operatives will move all picked items to
order/pick slip, the warehouse operative has to the dispatch area and signs the issue
inform the warehouse manager. The warehouse order/picking slip.
manager will provide direction to operatives.
6 Procedures
6.1 PFSA branch will collect and receive requisition/report from SDP by mail, fax, and telephone.
6.2 Record date and time of arrival and assign a request number for the requisitions.
6.3 Enter customer request in the system.
6.4 Allocate items and quantities to be delivered to the health facilities.
6.5 Reconcile quantities with the available fund of the customer by proration, if there is
shortage of fund.
6.6 When there is an additional need from the SDP or when the Storage and Distribution officer observes the
need for adjusting the request of the health facility, the request can be adjusted, considering the allocated
fund of the health facility.
6.7 Issue order will be prepared and communicated to warehouse manager.
6.8 Warehouse Manager will prepare pick slip/ or use the issue order as a pick list and give it to Warehouse
Operatives.
6.9 Warehouse operatives pick items as they are described in the issue order/pick list (bin location, description,
unit, expiry date, batch number, and manufacturer).
6.10 When an item is not found as described on the issue order/pick slip, the warehouse operative has to inform
the warehouse manager. Warehouse Manager will instruct the Warehouse operatives what options to pursue.
6.11 Warehouse operative moves all picked items to the dispatch area and signs the issue order/picking slip
handled by him/her.
6.12 Warehouse Manager and dispatch officer will verify dispatched items against the issue order/pick slip and
both sign the issue order/ pick slip.
6.13 The issue orders/pick slips are sent to the store clerk for invoicing (cash or credit invoice).
6.14 The store clerk prepares invoices for the items described on the issue order and sends the original and all
copies of the invoice to warehouse manager.
7. Amendment History
Note: The format for “issue order” and “Cash and credit delivery invoices (annex 13 and 14)” is attached to this
SOP.
PHARMACEUTICLALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Both central and branch warehouses can supply pharmaceuticals to health facilities and other customers. The
procedure for handing over of both RDF and program supplies is the same.
2. Purpose
To properly carry out the handover of items from central or branch warehouses to drivers/receivers for delivery to
health facilities.
3. Scope
This SOP is used at the time of hand over of items from central/branch warehouses to drivers/deliverers.
4. Responsibilities
Title Responsibility
Warehouse Manager and Handover of items to driver/receiver
dispatch officer
Driver/receiver Counting and verification with the documents before signing for
approval of receipt.
5. Process map/Flowcharts
Start
Driver/deliverer,
. warehouse manager and dispatch
officer sign the invoices.
6.1 The driver or the authorized receiver is called into dispatch area and given the invoices for the
items to be delivered.
6.2 The receiver/driver counts the dispatched items and verify against the invoices.
6.3 Any partially filled cartons are packed and sealed, after count, in front of the driver/receiver.
6.5 One original and one copy of the invoices are given to the driver/receiver to be submitted to the
health facilities.
6.6 Items are loaded on the vehicle. Loading on vehicle should be arranged in such a way that items for
the nearest HF are loaded last and for the remotest first.
6.7 Distribution of invoices: Storekeeper, finance, documentation follow up and two copies for driver.
7. Amendment History
Note: The formats for “Delivery invoices (annex 15)” is attached to this SOP
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Revision: 1 Title:
Handover items from driver/ Receiver to Health
facilities
Lead Author: Directorate approval: Management Document no: SOP/PSD/013
approval:
Date:
1. Introduction/background
Drivers or any authorized person who received items on behalf of health facilities has the obligation to deliver the
items and accompanying documents and bring back proof of delivery.
2. Purpose
3. Scope
This SOP is used at the time of hand over of items to health facilities at their location.
4. Responsibilities
Title Responsibility
Driver receiver Handover of items at health facilities.
Bring proof of delivery from the health facility.
5. Process map/Flowcharts
Start
Yes
Mention the discrepancy or damage on
the location provided on the invoice
Discrepancy and sign by both the driver and the
No HF’s recipient
Note: The format for “Delivery invoices (annex 15)” is attached to this SOP.
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Pharmaceutical products with known or suspected quality problems must be collected from customers when
authorization to do so is obtained.
2. Purpose
To stop the distribution and use of pharmaceutical products with known or suspected quality
problem.
To collect products with known quality problem.
3. Scope
This SOP is used when there is authorization for product recall from concerned body or regulatory authority.
4. Responsibilities
Title Responsibility
Distribution process owner Ascertain that all customers are communicated and the products are
collected in time.
Branch manager Ascertain that all customers are communicated and the products are
collected in time.
Storage and distribution officer Communicate customers for product recall
5. Process map/Flowcharts
Start
6. Amendment History
Note: The format for “Stock Return Memo (annex 16)” is attached to this SOP.
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Date:
1. Introduction/background
Disposing of expired pharmaceuticals at regular intervals is one of the prescriptions of Good Storage Practice and
thus it has to be adhered by all warehouses. Warehouse has to dispose expired item on quarterly basis.
2. Purpose
To prevent the risk of mix up of expired and non-expired products.
To utilize the storage space effectively.
To facilitate write off from financial ledgers.
3. Scope
This SOP is used in storage warehouse during disposal of expired items and follow-up on expired items.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Follow-up proper storage and disposal of expired Pharmaceuticals.
Warehouse manager Check and separate expired item from usable one.
5. Process map/Flowcharts
Start
6.3 If the item is confirmed expired it should be stored on isolated area until disposal.
6.4 Every quarter the list is compiled and reported to the regulatory authority for inspection and
disposal by the inspectors of the authority.
6.8 Dispose the items in accordance with instructions given by the inspectors
6.10 Send copies of Disposal certificate to finance and other relevant bodies.
7 Amendment History
Note: The format for “Certificate of Disposal (annex 17)” is attached to this SOP.
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Date:
1. Introduction/background
During work items can be damaged or broken. Appropriate measures described in the distribution manual should
be taken for damages and breakages occurred due to negligence by a worker. The disposal of damage/broken
items, for whatever reasons, should be conducted by this SOP.
2. Purpose
To facilitate write off from financial ledgers
To keep the warehouse clean
To utilize the storage space effectively
To minimize occupational hazard
3. Scope
The disposal of damage and broken items performed every quarter. This SOP includes the damage and
broken found in the storage warehouse, it does not include items damaged or broken during receiving,
which will be treated in a separate SOP.
4. Responsibilities
Title Responsibility
Warehouse Manager Collecting, separating damaged/broken items from usable one and
reporting to Storage and Distribution Officer.
Warehouse operatives Reporting damaged/broken items to Warehouse Manager.
Storage and Distribution officer Coordinate disposal of damaged/broken items with relevant bodies.
5. Process map/Flowcharts
Start
Note: The Reporting format for “Damage/ Breakage is attached to this SOP (annex 18)’’
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Revision: 1 Title: Disposal of damaged items found during inspection of
foreign purchased items at PFSA warehouse receiving
area
Date:
1. Introduction/background
Since an insurance claim can be made for damaged items found from newly arrived supplies purchased from
abroad, careful physical inspection of the new arrival should be performed. For locally supplied items the receiving
storekeeper should not accept damage items.
2 Purpose
To get disposal certificate for insurance claim.
To efficiently utilize WH space
To avoid risk of receiving damaged items and registering as sound items.
3 Scope
The activities for disposal of damaged items found during receiving starts with inspection of the new arrival,
separating the damaged items, reporting and follow up until disposal.
4 Responsibilities
Title Responsibility
Warehouse Manager Inspecting newly arrived items for damage, putting in a separate place
and reporting to Storage and Distribution Officer.
Storage and Distribution Officer Communicate the report to relevant bodies (FMHACA/regional/zonal
regulatory bodies, Deputy director for Operation, Branch manager,
fund Management Directorate) for disposal and follow up.
5 Process map/Flowcharts
Start
Date:
1. Introduction/background
Products with quality problems have to be disposed off. However, due to the necessity of settling claims with
suppliers, the products cannot be disposed right away. They should be kept in separate place until final
decision is reached. Some suppliers may demand disposal certificate for the products. The mode and place of
disposal is another issue to for which decision has to be given.
2. Purpose
To account for product with quality problem.
To get destruction certificate for claim (from supplier).
3. Scope
Products with quality problem should only be disposed when authorization to do so is obtained from supplier or
regulatory authority. It is also necessary to ascertain the place of disposal i.e., whether it is at center or at branch.
4. Responsibilities.
Title Responsibility
Warehouse Manager Collect products with known quality problem and place in a
separate area.
Communicate the problem to Storage and Distribution Officer.
Storage and Distribution Officer Coordinate the disposal with relevant bodies.
5. Process map/Flowcharts
Start
Date:
1. Introduction/background
The potency of some test kits and drugs depends on cold storage. For these products, the cold chain must be
maintained at every stage. It is important to look the manufacturer temperature specification. For most test kits
and cold chain drugs, the temperature range is between 2-8oc (not including vaccines). Freezing is as damaging as
high temperatures.
2. Purpose
4. Responsibilities
Title Responsibility
Warehouse Manager Check the condition of newly arrived cold box that contain the product.
Monitor proper transfer of the product to the cold room.
Record the temperature of the cold room twice daily.
Report any cold chain problem to storage and Distribution Pharmacist.
Warehouse operatives Transfer products to cold room properly.
Storage and Distribution Officer Investigate and take action on cold room related problems.
5. Process map/Flowcharts
Start
Yes
6.1 Check the condition of the cold boxes that contain the product. That is whether the cold chain is maintained or
not during receiving.
6.2 If cold chain is not maintained as per the specification, during receiving, the Warehouse Manager for Receiving
Warehouse shall report the condition to the Storage & distribution Officer.
6.3 The Storage and Distribution Officer together with the quality control unit will investigate the problem and
decide what course of action to pursue.
6.4 If cold chain is maintained, the Storekeeper for receiving Warehouse transfers the items to the storage area
where the cold room is located.
6.5 The transfer of the items from receiving area to cold room should be done within 30 minutes from time of
arrival.
6.6 The temperature of cold room should always be checked by the warehouse Manager. If the temperature is
outside the required range, he/she should report to the distribution pharmacist immediately.
6.7 The temperature recording device must be validated regularly to ensure its proper performance.
7. Amendment History
Date:
1. Introduction/background
The potency of some test kits and drugs depends on cold storage. For these products, the cold chain must be
maintained at every stage. Freezing is as damaging as high temperatures. When preparing dispatch and during
delivery, care should be taken to maintain the cold chain.
2. Purpose
This SOP is used to maintain cold chain during receiving, storage, issue, transportation and delivery of cold chain
cold chain products.
3. Scope
Maintaining cold chain of cold chain products starting from dispatch until the product reaches its destination.
4. Responsibilities
Title Responsibility
Warehouse Manager Make sure proper functioning of cold room.
Warehouse operatives Pack cold chain items in suitable cold box with ice pack properly.
5. Process map/Flowcharts
Start
Make sure that the ice bags are not in contact with
the product.
Date:
1. Introduction/background
There are several reasons that require the transfer of stock from one branch to another. Short expiry, overstock
and slow moving items have to be transferred between branches and be utilized efficiently. (Forecasting and
capacity building sub-process) by assessing the overall stock status of the agency,(the stock available at central
stores, scheduled items and items on branch warehouses), can give decision on the issue of the transfer.
2. Purpose
To minimize wastage rates.
To address emergencies
To transfer over stock, slow moving and short expiry items between and among branches.
3. Scope
The demand for the transfer of items between branches can be raised from the receiving branch,
sender branch or from head office. Whatever be the source for the demand, the transfer of items
between branches should be approved by the forecasting and capacity building sub-process.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Coordinate the transfer of items between branches once the transfer
is agreed between branches.
5. Process map/Flowcharts
Start
6.1 If the transfer is agreed up on, the items will be transferred from sender branch to the recipient branch
either directly or through central warehouses.
6.2 If the item is to be transferred through central warehouses, the central warehouse should store the items
on separate area until loaded on the next available truck to the destined branch.
6.3 The sender branch makes use of Stock Transfer Voucher for transferring to central stores or branches.
6.4 The recipient branch/central warehouse makes use of Inter Branch Stock Transfer Voucher for recording
of the receipt.
7. Amendment History
Date:
1. Introduction/background
Cyclic counting is a continuous counting, for example every week or each month by dividing the inventory in
different group, with reconciliation of discrepancies. Cyclic count can take place without interrupting normal
operations. Cyclic counting is primary focus on items with high value and high turnover.
2. Purpose
To verify physical inventory with the quantity on bin/stock card at specific date.
To strengthen good storage and distribution practice
To control theft and unknown disappearance of items
To take appropriate action in cases of variance between counts and records.
3. Scope
This SOP focuses on specific items that have high turnover rate, high value or prone to theft.
4. Responsibilities
Title Responsibility
Warehouse Manager Comply with the schedule prepared by Storage and Distribution
Officer for cyclic count.
Storage and Distribution Officer Select items for cyclic count; prepare schedule and assigning the
counting groups.
Communicate the results of the cyclic count to Distribution Process
owner/Branch Manager
5. Process map/Flowcharts
Start
Halt receipt and issue of item selected until the completion of the
count and verification with record documents
Yes
6.1 The Storage and distribution officer will select items on which physical inventory to be made.
6.2 A format is used to list down the details of the items on which the physical count is to be carried out. The
contents of the format are: Description, unit, manufacturer, expiry date, batch number, sound, damaged, total
and a blank column with the caption “physical count”.
6.3 It is to be made sure that all receipts and issuances are entered into the records before physical count
commences.
6.4 The receipt and issue of the items to be counted should be halted until the completion of the count and
verification with record documents.
6.5 A counting group will be assigned.
6.6 The counting group will undertake the physical inventory and report to the result to the Storage and
Distribution Officer.
6.7 The physical count is then compared with the balance records from bin card and stock card.
6.8 If the count and records match then a report mentioning same will be written and filed.
6.9 If the bin / stock card balances do not match the physical count, i.e. there is overage or shortage, recount
should be made for confirmation.
6.10 If after recount still the discrepancies exist, the distribution pharmacist will report the finding to the
distribution sub process owner (Branch Manager).
6.11 Reasons for the variances will be investigated and appropriate actions will be taken accordingly.
6.12 Adjustments of both financial and inventory records are then made in accordance with the physical count
subsequent to authorization by responsible body.
7 Amendment History
Note: The format for cyclic count (annex 19) is attached to this SOP
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Standard Operating Procedure
Revision: 1 Receiving, storage & distribution of Narcotic and
Title:
Psychotropic substances (controlled substances).
Date:
1. Introduction/background
Narcotics and psychotropic drugs are governed by the rules and regulations issued by the regulatory authority.
Security measures, therefore, have to be taken in receiving, storage and distribution of these substances.
2. Purpose
This SOP is used to comply with the rules and regulations of the handling of narcotics and psychotropic
(controlled) substances.
3. Scope
This SOP describes the procedures for receiving, storage and distribution of narcotics and psychotropic
substances.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Proper receiving, storage and distribution of narcotic and
psychotropic drugs
Keeping appropriate document and records of narcotics and
psychotropic substances.
Warehouse Manager Notify the responsible Officer the arrival of a new
narcotic/psychotropic substance.
Carry out inspection of newly arrived narcotic/ psychotropic
substance in the presence of the responsible officer.
5. Process map/Flowcharts
Start
The dispatch will be checked and verified against issue order and The recipient is then receives the product from
invoice (STV) by the warehouse manager, the dispatch officer and the receiving warehouse manager and packed
Storage and Distribution Officer. All will sign on the documents. immediately in his/her presence
6 Procedures
6.1 The warehouse manager for receiving warehouse will immediately notify the responsible pharmacist the
arrival of a new narcotic/psychotropic substance.
6.2 On receiving narcotic/psychotropic substance, if there is a breakage or tampering of sealed cartons, it should
be reported to the responsible pharmacist before the deliverer leave the receiving bay. The Officer will
investigate and pursue appropriate action, including counting the contents and verifying with delivery
documents.
6.3 The inspection of newly arrived narcotic/psychotropic substance will be carried out in the presence of the
responsible pharmacist.
6.4. Discrepancies found during inspection of narcotic/psychotropic substances should be immediately reported to
the Regulatory Authority and procurement sub process.
6.4 After inspection and Goods Receiving Voucher is prepared the product is transferred from receiving to the
storage area where it is stored in special portioned area/room. The storekeeper for storage warehouse signs
the GRV.
6.5 A separate GRV should be used for recording the receipts of narcotic/psychotropic substances.
6.6 The lock of the partitioned area/room should be hold by the responsible Officer.
6.7 When a health facility/ customer made a request for a narcotic/psychotropic substance, or when a
narcotic/psychotropic substance is to be transferred between and among PFSA warehouses a separate issue
order and invoice/STV will be prepared.
6.8 The responsible Officer unlocks the room for dispatch.
6.9 The dispatch will be checked and verified against issue order and invoice ( STV) by the warehouse manager,
the dispatch officer and the pharmacist. All will sign on the documents.
6.10 The recipient is then receives the product from the receiving warehouse manager and packed immediately in
his/her presence.
6.11 Keep a special register recording the transaction of the detail.
7. Amendment History
Note: The list of narcotic and psychotropic drugs (annex 19) is attached to this SOP
PHARMACEUTICALS FUND AND SUPLLY AGENCY
Date:
1. Introduction/background
It is essential to have a contingency plan in place before a refrigerator/cold room failure occurs. An arrangement
should be made to move the items to another refrigerator/cold room if maintenance is not achieved within a
reasonable period of time. To prevent the risk of electric power break a stand by generator should be planned in
advance. An arrangement should be made with a responsible professional who can always be contacted with
telephone call for immediate maintenance of cold room in case there is an emergency failure.
2. Purpose
To protect cold room items from being damaged due to interruption of cold chain.
3. Scope
4. Responsibilities
Title Responsibility
Warehouse Manager Monitor temperature reading of the cold room, report deviations to
Storage and Distribution officer
Storage and Distribution Officer Facilitate maintenance of the cold room
Transfer items to another cold room, if maintenance is not achieved in
time.
5. Process map/Flowcharts
Start
6.1 An arrangement (a contract) should be made with a person who can always be contacted with telephone call
for immediate maintenance of cold room in case there is an emergency failure.
6.2 All concerned staffs should know the name and telephone number of the company /person with whom
contract for maintenance of the cold.
6.3 A temperature recording device for the cold room has to be fixed at location convenient for monitoring.
6.4 The record of the temperature of the cold room is to be registered on a card posted on the entrance wall/
door of the cold room.
6.5 The storekeeper for the storage warehouse records temperature of the cold room on the card by reading from
the device. Record is taken at 8:30 AM and 2 PM.
6.6 The normal range for the cold room temperature is 2-80C. In the event that the temperature range is outside
2-80C for two consecutive readings the warehouse manager has to report to the responsible officer.
6.7 The pharmacist immediately notifies the problem to the responsible staff from General Service.
6.8 If the problem after being investigated by the staff from the GS cannot be fixed right away, a service call
should be made to the company or the person contracted out for cold room maintenance.
6.9 If the maintenance of the cold room cannot be carried out in due time, the cold chain products should be
transferred to another available cold room according to their nature and sensitivity.
7. Amendment History
Date:
1. Introduction/background
Pharmaceutical warehouses/stores should be kept tidy. A clean, tidy store is easier to manage. Maintaining a
clean environment requires a regular routine of cleaning shelves and a daily cleaning of floors. A cleaning
schedule should be adhered by the responsible staff. Adequate personnel for scheduled clean up and cleaning
equipment should be made available.
2. Purpose
To keep receiving, storage and dispatch areas clean
Maintain a clean working environment
3. Scope
The cleaning tasks for a warehouse/store include cleaning of floors, shelves and warehouse toilets.
4. Responsibilities
Title Responsibility
Warehouse Manager Enforcing cleaning schedule
Warehouse operatives and Cleaning of warehouses/stores and maintaining clean environment for
cleaners work.
5. Process map/Flowcharts
Start
6.5 Garbage and scraps collected during working hours should be placed in covered dust bins until disposal and
spills should be wiped up immediately.
7. Amendment History
Date:
1. Introduction/background
Delivery routes should be planned to make the best use of available resources. Delivery routes and schedules
should be arranged so that vehicles start each journey fully loaded. It is inefficient to use large vehicle to deliver
small quantities of supplies. Unless full loads are being dropped off at a single delivery point, a delivery route may
be cheaper to operate than a series of trips back and forth.
2. Purpose
To plan delivery routes
Create good communication with drivers.
To use available resources efficiently and effectively
To practice good fleet mgt system
3. Scope
A detailed delivery route and scheduling plan should be prepared every fiscal year and reviewed as
required. The plan describes how all warehouses and facilities will be served.
4. Responsibilities
Title Responsibility
Storage and Distribution Officer Preparation of routing and scheduling plan
Conduct briefing and debriefing session with the drivers before
they leave and on their return
Routing and Scheduling Officer. Day to day follow up of the routing and scheduling activity
5. Process map/Flowcharts
Start
For each group, plan the route that serves HF with the
least kilometers, this may be obvious or you may need to
try a number of iterations.
6.1 Locate each facility (delivery point) on a large scale road map.
6.1 Group delivery points logically by reference to geography and the road network.
6.2 For each group plan the route that serves them all with the least kilometers, this may be obvious or you may
need to try a number of iterations.
6.3 Calculate the average physical volume required by each facility in each delivery cycle.
6.4 Add the total volume for each route to determine the necessary truck size.
6.5 If one or two routes require exceptionally large or exceptionally small trucks, consider splitting the very large
routes and combining the small routes with another adjacent route. Aim for an optimum truck size that will
service all routes reasonable efficiently.
6.6 Determine the running time for each route preferable by debriefing drivers who have the necessary local
knowledge. Cross check their estimate by calculation using an average running speed of 60 Kph on tarmac and
40 Kph on gravel and allowing 4 to 6hrs per delivery point. If any route will take more than 5 days, consider
splitting the route.
6.7 Schedule the routes as evenly as possible over the 2 month delivery period. The schedule should cover all
routes and provide some recovery time in case of delay, bad weather and capacity for emergency orders. It
should also include time for planned vehicle maintenance. (By spreading the routes as evenly as possible over
the 2 month delivery period you also spread the order processing and warehouse workloads).
6.8 Schedule the warehouse picking and re-supply order receipt and process phased to each route.
6.9 Conduct briefing and debriefing session with the drivers before they leave and on their return.
6.11 Maintain fuel and kilometer record for each trip with respect to each truck/vehicle under his custody.
6.12 The routing and scheduling plan shall be reviewed now and then
7. Amendment History
Note: Issues to be discussed during de-briefing attached to this SOP (annex 20).
Annex
Annex 1: Record of incoming goods
PHARMACEUTICALS FUND AND SUPPLY AGENCY
Date: _________
Name and tel. no. of the person who delivered the goods__________________
S/No. Date of receipt Time of Description of the goods received (as it is Unit Quantity Remarks
receipt described on delivery document)
Remark:
1. When items are supplied in pallets, the pallet should be opened in the presence of the responsible officer
2. When items are supplied in containers, the contents of the containers should be described e.g. cartons
Annex 2: Checklist for physical inspection
Annex 3: Transit Transfer Voucher
Annex 4: Good Receiving voucher (GRV)
Date---------------
Supplier______________________________________
S/No Item Description Unit Qty on Qty Unit Total Manufacturer Batch Expiry
code invoice received cost cost no. date
s.no Item Description Unit Damaged Short Unit Total Manufacturer Remarks on
code qty landed cost cost damage and
qty short landed
items
Distribution: Original: Finance, Copies to: Document follow up, Store, file
Annex 5: Inter organizational Goods Receiving Voucher
Date--------------
S/No Item Description Unit Qty Qty Unit Total Manufacturer Batch Expiry
code on received cost cost no. date
STV
S/No Item Description Unit Damaged Short Unit Total Manufacturer Remarks on
code qty received cost cost damage
qty and short
received
items
Distribution: Original: Finance, Copies to: Document follow up, Store, file
Annex 6: Inter –Store Transfer Voucher
Received by store_______________________________
S/No Item Description Unit Qty Unit Total Manufacturer Batch Expiry
code cost cost no. date
Distribution: Original: Finance, Copies to: Document follow up, Transferor and receiver
Annex 7: Allocation of breakdown
Annex 8: Issue order
Annex 9: Stock Transfer Voucher
STV No:
Date ----------------
Transferred to__________________________________
s.no Item Item Unit Qty Unit Total cost Manufacturer Batch Expiry
code name cost no. date
s.no Item Item Unit Damaged Short Unit Total Manufacturer Remark on
code name qty received cost cost damage and
qty missing
(missing)
I have received the above goods with the remarks there of in good condition.
Distribution: Original: Receiver branch/central store, Copies to: Finance, Document follow up, Store, one copy
signed and sealed by receiver and returned to sender
Annex 10: Delivery note
DN NO:
Date-------------
Transferred to _________________________________
S/No Item Item Unit Qty Unit Total cost Manufacturer Batch Expiry
code name cost no. date
Sender store: name & sig__________________ Checked by________________ Carrier/Driver: name and sig.
_________
S/No Item Item Unit Damaged Short Unit Total Manufacturer Remark on
code name qty received cost cost damage and
qty missing
(missing)
I have received the above goods with the remarks there of in good condition
Distribution: Original: Receiver branch/central store, Copies to: Finance, Document follow up, Store, one copy
signed and sealed by receiver and returned to sender
Annex 11: Discrepancy reporting format
Date----------------
Invoice no.__________
Driver’s name_________
S/No Item Description Unit Invoiced Received Difference Unit Total Remarks
code cost cost
Qty qty
Receiver: Name and sig __________________ Driver/carrier; name and sig ____________________
Witnesses 1.______________________
2. _____________________
Annex 12: “Receipt for documents”
Annex 13: Cash delivery invoices
DIC no------------
Date: ------------
Name of Store______________________________
Customer name____________________________
S/No Item Item name Unit Qty Unit price Total Manufacturer Batch Expiry
code price no. date
Sender store: name & sig__________________ Checked by________ Carrier/Driver: name and sig. _________
S/no Item Item Unit Damaged Short Unit Total Manufacturer Remark on
code name qty received price price damage and
qty missing
(missing)
I have received the above goods with the remarks there of in good condition
Date: ___________
Name of Store_________________________
Customer name_________________________
s.no Item Item name Unit Qty Unit price Total Manufacturer Batch Expiry
code price no. date
Sender store: name & sig__________Checked by________ Carrier/Driver: name and sig. _____
s.no Item Item Unit Damaged Short Unit Total Manufacturer Remark on
code name qty received price price damage and
qty missing
(missing)
I have received the above goods with the remarks there of in good condition :
SRM NO:
Date. ----------------
Document no of customer________________________________________
S/No Item Description Unit Qty Unit Total Manufacturer Batch Expiry
code cost cost no. date
Delivered by: ______________________ Checked by: __________ Received by: Name______________ Sig.____
Distribution: Original: Finance, Copies to: Document follow up, Store, file
Annex 17: Certificate of Disposal
Annex 18: Reporting format for “Damage/ Breakage
Date---------------
-
Reporting format for Items Damaged and Broken during warehouse operation
s.no Item Item Unit Broken Unit Total Manufacturer Expiry Batch Remarks
code name or cost cost date no.
damaged
Qty