BMR of Vericef 500capsule

VERITAS PHARMACEUTICALS LTD
TOLL MANUFACTURING AT APEX PHARMACEUTICALS LTD.
Batch Manufacturing Record (BMR)

Product Name : VERICEF 500 CAPSULE Batch No.
BMR No. : BMR/AB020 Issue Date : SEP, 2014
Version No. : 01 Review Date : SEP, 2017
Superseded Doc.
: Nil Presentation : Alu-Alu Blister
No.
Std. Batch Size : 100000 Capsules or 50.400 Kg Shelf Life : 24 months
Actual Batch Size : 100000 Capsules or _____________ Kg
Product Description : Pink opaque body, deep blue opaque cap, containing off white color compacted powder. Each
capsule contains Cephradine Anhydrous BP (Compacted) Eq.to 500 mg Cephradine.
Product Code : AB020 DAR No. : 365 95 23 Mfg. License No.: 288 & 492 Page 1 of 17
Prepared by Checked by Reviewed by Approved by
(Executive, PD) (Sr. Executive, PD) (Manager, Production) (QA Manager)
Effective Date: 23/09/2014 Valid Up to: 22/09/2017

BMR Revision Records
Version Date Revision History
01 22/09/2014 First version [New]
BMR Issued by : Mfg Date: Starting Date: Approved for start of Batch Manufacturing
BMR Received by : Exp. Date: Complete Date:

(Sign & Date) (QAM, APL)

BMR No. : BMR/AB020 Issue Date : SEP, 2014 Review Date : SEP, 2017
Version No. : 01 Checked By: Approved By: Page 2 of 17
1. Introduction:
1.1. General Description:
Each Aphrin 500 Capsule contains Cephradine Anhydrous Compacted Eq.to 500 mg Cephradine BP.
Technical Description
Composition Composition for 1,00,000 Capsule

Code No. Ingredients
Per Capsule (mg) (Kg)
Cephradine Anhydrous (compacted)

RM0041 500.00 50.00
RM0259 Purified Talc 2.00 0.200
RM0177 Magnesium Stearate 2.00 0.200
Total wt. 504.00 (mg) 50.400 (Kg)
E.H.G shell- Size#0 (Overage 2.0 %)

RM0112 1 Pcs 1,02,000 Pcs
[Body: Pink opaque; cap: Deep blue opaque]
Total Qty. 1,02,000 Pcs
3. Process Details:
Total process for preparing Texit 200 Capsule is subdivided into Six (6) stages. BMR will cover Stage 1, 2, 3, & 4, BPR will cover Stage 5 & 6.
Stage 1 : Dispensing Stage 2. : Sieving and Blending Stage 3 : Encapsulation

Stage 4 : Polishing & Checking Stage 5 : Primary Packing Stage 6 : Secondary Packaging
BPR consists of two (2) parts. BPR Part 1 will cover Stage 5; BPR Part 2 will cover Stage 6.
Temperature and Relative Humidity Record
Limit: Temperature between 15-25C and Relative Humidity within 40-50%

Temperatur Done by Checked by Temperatur RH Done by Checked by

Date Time Stage RH (%) Date Time Stage
e (C) (PO) (TL) e (C) (%) (PO) (TL)
Note: Room temperature & Relative Humidity [RH] should be checked at the start of each stage and every 2 hours intervals. Checked By
(PE):_________________
1.1 Stage 1: Dispensing of Ingredients

Dispensing of Ingredients has to be done in the dispensing booth.

1.1.1 Dispensing of API & excipients :
Cleanliness of the materials container to be dispensed
Instruction:
Check the following in the AIRLOCK before dispensing (Put to fill up).
Cleanliness of the incoming containers. Complies Not Complies
No breakage/leakage in the containers Complies Not Complies
No materials except relevant to this product is

Complies Not Complies
present
Correct materials in sufficient quantity are
Complies Not Complies
present
Checked by:
Checked by (PE): Checked by (QAE):
(Warehouse Personnel):
1. Dispensing
I Check before dispensing (Put mark where applicable)


Removal of all extraneous materials, equipment and documents related to previous product/batch from the room.
Cleanliness of the room/ utensils/ accessories, if this is the first batch following a product change, remove the CLEANED label from the Room/equipment and include in the batch
wallet. record the following:
Name of the
Equipment ID Previous Product Batch No. Checked by
Equipment
Electronic Balance
Electronic Balance
Verify that the balances to be used are within their calibration period. Record the following:
Next Calibration
Equipment ID Name of the Balance Calibration Date Checked by
Date
Electronic Balance
Electronic Balance
Exhaust system working

Temperature: .. (15 25) o C
Humidity: ... (40 50) % RH
Performed by: Checked by (Production): Checked by (QA):
Date: Date: Date:

READY FOR DISPENSING
1.1.2 Dispensing Order:


Signature of
Starting Date: Starting time (AM/PM):
Production Executive:
1. Dispense the following items as per SOP and fill up the following table accordingly :
Sl. Amount Amount Checked By

QC Ref. Weighed
No Code Raw Material Required R.R. No. RE-EV Date Dispensed
No. By (PO) PE QAE
. (kg) (Kg)
Cephradine kg Potency ()
Anhydrous
1. RM0041
(Compacted)
50.00
kg Potency ()
2. RM0259 Purified Talc 0.200
3. RM0177 Magnesium Stearate 0.200
*E.H.G shell- Size#0

[Body: Pink opaque; ____________
7. RM0112
cap: Deep blue Pcs.
opaque]
N.B. *Qty. of E.H.G shell (Overage 2.0 %) will fixed after calculation of number of capsules. See the below calculation section.
Remarks (If any):
Bin Card Posted BY

Closing Date: Closing time (AM/PM):
(Warehouse Personnel) Sign
Calculation of number of Capsule


Instruction:
1. Follow calculation 1 when active is taken from a single Q.C. Ref. number.
2. Follow calculation 2 when active is taken from different Q.C. Ref. number.
Sl
No Calculation Remarks
.
1. When Cephradine Anhydrous(Compacted) is used from single potency:
i) Potency as Cephradine (): ___________ % Q.C. Ref. No. (): ___________________

Calculation 1
Qty. of Cephradine Anhydrous Compacted(Kg) (X) = Theoretical Qty. (Kg) X 100

Potency
= 50.00 Kg X 100
Potency
2. When Cephradine Anhydrous(Compacted) is used from different potency:
In case of two batches of Cephradine (Compacted):
Qty. of Cephradine (Compacted) used from batch (Batch A) = ---------------Kg.(Y)

Calculation 2
Qty. of Cephradine (Compacted) used from batch (Batch B) = (X) - (Y) X Potency (%) of Batch -A
Potency (%) of Batch -B
= Kg.
= Kg.

Calculated and Written By Checked By (QA Executive): Verified By (Production in Charge): Verified By (QA in Charge):
(Production Executive): sign and sign and sign sign and
date date and date date
1.1.3 Theretical fill weight of Capsule:

= Total Batch wt. (kg.) X 1000000 = mg/capsule
Total no. of Capsule (X)
1.2 Stage 2 : Sieving & Blending
Previous Product: Batch No.:

Area Cleanliness Checked By (QAE):

Precautions: 1. Remove all materials of the previous product before start of manufacturing.
2. Check cleanliness and dryness of all equipment and utensils before start processing.
3. Use facemask, hand gloves and protective dresses.
4. Check labels of the materials before using.
5. Ensure the integrity of the sieves before and after sieving.
6. Ensure that the line clearance checklist and CLEANED TAG are signed by PE and QAE.
Equipment Used ID No. Previous Product Batch No. Cleanliness Checked by (QAE)
Sifter N/ A
Drum Blender 02-096-001 Sign & Date
40 mesh SS screen N/ A
Log books completed and area labeled: Signature and date (PE):
Sieving & Blending: Inform PE and QAE to check the following materials for correctness:
Cephradine Anhydrous Kg
Purified Talc 0.200 Kg
Magnesium Stearate 0.200 kg
Material & Qty Checked by (PE): ___________________ Checked by (QAE): ___________________

2.2.1 Seive the Purified Talc & Magnesium Stearate through # 40 mesh SS screen manually. Transfer the sieved materials & Cephradine AnhydrousCompacted into a Drum
Blender.
Done by (PO) _______________________ Empty Polybags Checked By (PE): __________________________
2.2.2 Close the blender with lid and then lock the lid. Mix the total contents for 30 min.
Mixing Started ________am/pm; Mixing Finished ________am/pm; Done by (PO) _______________________ Checked by (PE) _______________
REMARKS IF ANY:
Note: In case of any deviations, it should be authorized by Quality Assurance. In case if any extraneous matter is observed on the materials, it should be immediately informed to the
Production Executive.
2.2.3 Inform QA (IPC) to draw the sample from the blender for analysis. QA (IPC) will check the Loss on Drying (LOD). Limit of LOD is NMT 7.00%.

Record the ID No. and Calibration information of used IPC instruments in the BMR.
Equipment Name Equipment ID No. Calibration Expiry
Moisture Analyser
Sampled by: _________ Time: _______am/pm Date: ___________ Loss on Drying (LOD) __________% Done by (IPC) ___________ Checked by (QAE) __________
2.2.4 Discharge the content of the blender into tarred double polylined plastic drums. Record the net weight and labeled the drums inside-outside correctly with PRODUCT
STATUS LABEL. Seal the drums keeping silica gel bags in between the polybag. Store the drum(s) in the intermediate bulk store awaiting Encapsulation on QA
Approval.
WEIGHING RECORD OF BLEND

Container No. Net Weight (Kg) Container No. Net Weight (Kg)
1. 2.
Total Weight of Blend: __________________ Kg
ID No. of the Balance: ____________________ Weighed By (PO): ______________ Checked By (PE/QAE): _______________
2.2.5 Reconciliation:
Theoretical weight of the Blended Materials (A) = Kg
Actual weight of the Blended materials (B) = _________ Kg
Analytical Sample (C) = _________ Kg
[A - (B C)] X 100
Unaccountable Loss = _________% Limit: + 2.00% Done by (TL):_____________ Checked by (PE):_____________ Checked by
A
(QAE):______________
REMARKS IF ANY:

1.1 Stage 3:
Encapsulation:
Previous Product: Batch No.: Area Cleanliness Checked By (QAE):
Precautions:
1. Remove all materials of the previous product before start of manufacturing.

3. Use facemask, hand gloves and protective dresses. Avoid dust and inhalation of powder.
5. Ensure that the line clearance checklist and CLEANED TAG are signed by PE and QAE.
Cleanliness Checked By (QAE)

Equipment Used ID No. Previous Product Batch No.
Hand Capsule filling Machine 02-145-002
Capsule Inserter Machine 02-145-003
Dust Collector N/A
LOG BOOKS COMPLETED AND AREA LABELLED: SIGNATURE AND DATE (PE):
2.3.1 Check the blended materials are available as per BMR. Checked by (PE): _________________ Checked by (QAE): _________________
2.3.2 Check the Capsule Shell size, Temperature and %RH before starting the encapsulation and make relavent entry into the log books.
2.3.3 Weigh the blended material into SS Plate, feed to the tray manually. Adjust fill weight; check Individual fill weight, average fill weight standard physical parameters as
given in the INITIAL PARAMETER CHECKING RECORD. Inform Production Executive (PE) to check the initial parameters.
Initial Parameter Checking Record: Theorectical fill weight: ________________mg/capsule
Done by
Sl. No. Parameter Standards Result Checked By (PE)
(PO)

Size#0, Pink opaque body, Deep blue opaque cap,

1 Appearance
containing off white color compacted powder.
2 Individual fill weight (mg) (___________ to __________) mg [Theor. Fill wt. 7.5%]
Average fill wt. of 10 Capsule

3 (___________ to __________) mg [Theor. Fill wt. 3%]
(mg)
4 Average E.H.G shell weight (mg) (98-102) mg
Initial Parameter Checking Record (In Case of Machine Resetting):
Done by
Sl. No. Parameter Standards Result Checked By (PE)
(PO)
Size#0, Pink opaque body, Deep blue opaque cap,

1 Appearance
containing off white color compacted powder.
2 Individual fill weight (mg) (___________ to __________) mg [Theor. Fill wt. 7.5%]
Average fill wt. of 10 Capsule

3 (___________ to __________) mg [Theor. Fill wt. 3%]
(mg)
4 Averager E.H.G shell weight (mg) (98-102) mg
2.3.4 Inform QA to collect initial sample. QA will record the results in In Process Checking Record by QA (Doc. No.: IPC/M/FP132-01). After getting QA approval, run the
machine.
2.3.5 In Process Appearance, weight and locking Check record of Capsule (By Production)

Wt. of Wt. of
Checke
10 Appearenc Lockin Checked 10 Appearenc Lockin
Date Time Date Time d Specification
Capsule e g By (PO) Capsule e g
By (PO)
(g) (g)
Appearance: Size#0, Pink opaque
body, Deep blue opaque cap, containing
off white color compacted powder.
Theor. Fill wt.(mg):_____________
Ind. Capsule wt. (mg):
(_____________ to _____________) mg
[(Theor. Fill wt. 7.5%) + EHGC wt.)]
Wt. of 10 capsules (g):

(_____________ to ______________) g
[(Theor. Fill wt. 3%) + EHGC wt.)]
Locking: Locked properly.
Limit set by (PE):_________________
Limit checked by (QAE):___________
Remarks:
Checked by (PE):
________________

Wt. of Wt. of
Checke
10 Appearenc Lockin Checked 10 Appearenc Lockin
Date Time Date Time d Specification
Capsule e g By (PO) Capsule e g
By (PO)
(g) (g)
Appearance: Size#0, Pink opaque
body, Deep blue opaque cap, containing
off white color compacted powder.
Theor. Fill wt.(mg):_____________
Ind. Capsule wt. (mg):
(_____________ to _____________) mg
[(Theor. Fill wt. 7.5%) + EHGC wt.)]
Wt. of 10 capsules (g):

(_____________ to ______________) g
[(Theor. Fill wt. 3%) + EHGC wt.)]
Locking: Locked properly.
Limit set by (PE):_________________
Limit checked by (QAE):___________
Remarks:
Checked by (PE):
________________
Remarks:
Net average wt. of Summation of all 10 Capsule weights [(from table(s)] mg

= mg
Capsule = Total number of 10 Capsule weights =
REMARKS IF ANY:

2.3.6 After Encapsulation, collect capsules into tarred double polylined plastic drums with proper label inside & outside of the drum and transfer to the WIP room for the
next stage polishing and checking.
1.2 Stage 4: Capsule Polishing & Checking: Capsule polishing is the step of removal of dust powder from the capsule shell after encapsulation by a capsule polishing
machine or manually with towel if machine not available and checking operation is done by visual checking of defective capsule during encapsulation & polishing. Polished
& checked capsule collect into tarred double polylined plastic drums with proper label.
Previous Product: Batch No.: Area Cleanliness Checked By (QAE):
Precautions:
1. Remove all materials of the previous product before start of manufacturing.
3. Use facemask, hand gloves and protective dresses. Avoid dust and inhalation of powder.
5. Ensure that the line clearance checklist and CLEANED TAG are signed by PP and QAE.
Cleanliness Cleanliness
Equipment Used ID No. Previous Product Batch No. Checked By (PE) Checked By
(QAE)
Capsule polishing machine
S S perforated bowl N/A
Dust Collector N/A
Cleaned Towel dedicated for
N/A
Aphrin
2.4.1 Storage: Label each drum inside outside correctly. Seal the drums keeping silica gel bags in between polythene bags and store the drums in the WIP room awaiting
blistering on QA Approval.
2.4.2 Reconciliation:
Theoretical Qty. of the Capsule (A) = _____________________ Pcs (From step 2.2.4)
Actual Qty. of the Capsule (B) = _____________________ pcs (Total wt. of filled Capsule divied by Net average wt. of Capsule)
IPC Sample (C) = _____________________ pcs
In process rejects (D) = _____________________ pcs
REMARKS IF ANY:

[A - (B C D)] X 100
Unaccountable Loss = __________ __% Limit: + 2.00% Done by (TL):______________ Checked by (PE):_____________
A
3.0 Job Allocation Data Sheet
DATE OPERATION FROM TO OPERATOR ID No. TOTAL MAN HOUR CHECKED BY (TL/PE)
Dispensing
Seiving and
Blending
Encapsulation
Polishing &
Checking
Grand Total Man Hour
4.0 Note any Deviation, OOS (Valid/Invalid), Change Request regarding the BMR
5.0 Batch Completion Record

All the steps are done according to the BMR and if not, deviation/ OOS / change request are reported (in Step 4). All data are recorded properly.

Checked By (PE): ________________ Checked By (QAE): ________________
6.0 Production Comments
Production Approval:
_______________
7.0 QA Comments
QA Approval: _______________

BMR of Vericef 500capsule

Transféré par

Informations du document

Description originale:

Titre original

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

BMR of Vericef 500capsule

Transféré par

Droits d'auteur :

Formats disponibles

VERITAS PHARMACEUTICALS LTD

TOLL MANUFACTURING AT APEX PHARMACEUTICALS LTD.

Batch Manufacturing Record (BMR)

Prepared by Checked by Reviewed by Approved by

(Executive, PD) (Sr. Executive, PD) (Manager, Production) (QA Manager)

Effective Date: 23/09/2014 Valid Up to: 22/09/2017

01 22/09/2014 First version [New]

BMR Received by : Exp. Date: Complete Date:

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 2 of 17

Composition Composition for 1,00,000 Capsule

Cephradine Anhydrous (compacted)

RM0259 Purified Talc 2.00 0.200

RM0177 Magnesium Stearate 2.00 0.200

Total wt. 504.00 (mg) 50.400 (Kg)

E.H.G shell- Size#0 (Overage 2.0 %)

Total Qty. 1,02,000 Pcs

Stage 1 : Dispensing Stage 2. : Sieving and Blending Stage 3 : Encapsulation

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 3 of 17

Temperatur Done by Checked by Temperatur RH Done by Checked by

1.1 Stage 1: Dispensing of Ingredients

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 4 of 17

1.1.1 Dispensing of API & excipients :

Cleanliness of the materials container to be dispensed

Cleanliness of the incoming containers. Complies Not Complies

No breakage/leakage in the containers Complies Not Complies

No materials except relevant to this product is

I Check before dispensing (Put mark where applicable)

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 5 of 17

Exhaust system working

Performed by: Checked by (Production): Checked by (QA):

Date: Date: Date:

1.1.2 Dispensing Order:

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 6 of 17

Sl. Amount Amount Checked By

2. RM0259 Purified Talc 0.200

3. RM0177 Magnesium Stearate 0.200

*E.H.G shell- Size#0

Remarks (If any):

Bin Card Posted BY

Calculation of number of Capsule

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 7 of 17

i) Potency as Cephradine (): ___________ % Q.C. Ref. No. (): ___________________

Qty. of Cephradine Anhydrous Compacted(Kg) (X) = Theoretical Qty. (Kg) X 100

2. When Cephradine Anhydrous(Compacted) is used from different potency:

In case of two batches of Cephradine (Compacted):

Qty. of Cephradine (Compacted) used from batch (Batch A) = ---------------Kg.(Y)

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 8 of 17

1.1.3 Theretical fill weight of Capsule:

Total no. of Capsule (X)

1.2 Stage 2 : Sieving & Blending

Previous Product: Batch No.:

Batch Manufacturing Record (BMR)

Version No. : 01 Checked By: Approved By: Page 9 of 17

Material & Qty Checked by (PE): ___________________ Checked by (QAE): ___________________

Batch Manufacturing Record (BMR)

i) Potency as Cephradine (): _ % Q.C. Ref. No. (): _________

Material & Qty Checked by (PE): _ Checked by (QAE): _

Checked By (PE): Checked By (QAE):