Possible content of a Standard Operating Procedure (SOP) for

Self-inspection: Performance, responsibility, reporting

No claim for completeness or accuracy.

Tasks and key aspects are just examples and might be adapted as long as they
comply with given regulations.

AB3 The workforce receives the preparation needed to maintain an effective work
environment.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
VALIDITY/TRAINING ERROR! BOOKMARK NOT DEFINED.
OBJECTIVES 4
AREA OF APPLICATION 5
AREAS OF RESPONSIBILITY 5
DEFINITIONS 6
DESCRIPTION OF THE SYSTEM USED TO IMPLEMENT SELF-
INSPECTIONS 7
INSPECTION PROGRAMME ERROR! BOOKMARK NOT DEFINED.
AUDIT TEAM 10
INSPECTION PLAN (AGENDA) 10
ASSESSMENT OF OBSERVATIONS 11
INSPECTION REPORT 12
CORRECTIVE/ PREVENTIVE ACTIONS - CAPA 12
ANNEX 1: CUSTOMER AUTHORIZATION AND SCHEDULING
(EXAMPLE) 14
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

SCOPE & APPLICABILITY

Define when the SOP will be valid and who needs to be trained (incl. time frame).

Validity

Employees

Department

Units

Training

Frequency

Target Population

Trainer

REVISION

Frequency

Tracking & Monitoring

Approval

S No Date Clause Changes Justification Approval Remarks

Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
OBJECTIVES

Describe your objectives and systems for performing GDP self-inspections (storage,
transport, distribution).

These may include but is not limited to:

 Assessment of the quality system

 Compliance with GDP requirements and standards

 Checking processes descriptions

 Checking training status

 Verification of the effectiveness of the existing GDP system

 Evaluation and constant improvement of the suitability and effectiveness of the quality
management system
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

AREA OF APPLICATION

Define all areas to which this SOP applies to (departments, sites, regions).

Take into consideration also specific (local) work instructions.

AREAS OF RESPONSIBILITY

Area of GM _ HR AGM - HR HOD MD

Work

XYZ A R C I

ABC

Define who is responsible for (examples):

 Planning self-inspections

 Conducting the self-inspection

 Supporting the self-inspection

 Writing the report

 Distributing and archiving the respective reports

 Tracking the actions/ measures

Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
DEFINITIONS

Provide definitions of commonly used phrases and abbreviations, like for example

 Self-inspection
 Observation
 Deviation
 CAPA (Corrective action and preventive action)
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

DESCRIPTION OF THE SYSTEM USED TO IMPLEMENT SELF-

INSPECTIONS

Describe for example:

1. Areas of application (who will be inspected by self-inspections at regular intervals?)

These may include but is not limited to:

 Receiving Area (Inbound)

 Warehouse (incl. packaging materials storage, raw materials storage,
pharmaceuticals storage, hazardous materials storage, storage for anaesthetics,
products under quarantine/ returns)
 Picking and packing, dispatch (Outbound)
 Technical materials qualification/ calibration (e.g. qualification of the warehouse
and the temperature monitoring system)
 IT infrastructure (e.g. validation of the warehouse management system)
 Quality Management systems incl. training
 Transport and transport services

Depending on the structure of the company, more areas might need to be inspected.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
2. Inspection process (what topics could be audited?)
These may include but is not limited to:

 Storage and transport processes

 Buildings, rooms, media and equipment

 Staff and training

 Procedures, documentation and reports

 Quality Management systems

 Validation and qualification plans and reports

 Hygiene rules

 CAPA (e.g. corrective measures from previous in-house/external audits)

 Processing recalls

 Handling complaints

 Qualification of suppliers and recipients

 Contracts

Depending on the structure of the company, more topics might need to be considered.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

AUDIT & COMPLIANCE

Define how you set up your inspection programme with minimum timeframes. Define how
you will set the frequency.
You can also define special occasions, when an unscheduled self-inspection may be
required, e.g.:

 Before inspection by the authorities

 Before important customer audits

 After the conversion or initial set-up of equipment

 For verification of the corrective measures resulting from self-inspections, inspections

by the authorities and customer audits

Describe extent of an unscheduled self-inspection.

Describe what will happen, if a self-inspection is postponed or cancelled.

Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

AUDIT TEAM

Describe role and responsibilities of lead auditor, co-auditor and the (local) quality
assurance.

INSPECTION PLAN (AGENDA)

Define how you set up your set inspection plan (agenda) for the self-inspection.
An inspection plan could cover:

 Self-inspection number (from the inspection programme)

 Name of area/unit

 Inspection date

 Name of participants (auditors)

 Focus of the self-inspection

 Schedule

 List of the instructions/documents to be checked

 List of observations from previous audits

Define distribution of the inspection plan.

Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
ASSESSMENT OF OBSERVATIONS

Define how you will rate your observations.

Example clauses:

 Critical1

o Non-conformity with the GDP regulations or with the existing QM

system or other legal rules that make the product useless and in the
worst case, could impact the patients' health.

o And/or missing key elements from the relevant GDP guidelines.

o Observations rated 'major' that are repeatedly recorded (from

previous audits).

 Major
o Non-conformity with the GDP regulations or with the existing QM
system or other legal rules that adversely influences the product
quality but does not have an influence on patients' health. Requires
immediate remedial measures.

o Non-conformities rated ‘minor’ that are repeatedly recorded (e.g.

from previous audits).

 Minor
o Non-conformities that do not have an influence on the product
quality or product approval but require remedial measures.

1
If a self-inspection is performed by one auditor only and he/she has recorded critical observations, an
additional specialist (from Company X-Pharmaceuticals or external) can be requested to verify the
assessment. During the concluding meeting, the auditor should point out this option.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

Describe how a final assessment can be made, for example:

 Satisfactory (no proof of non-conformity with regard to the requirements or product

quality).

 Unsatisfactory (proof of non-conformity that does not have a major influence on the
requirements or product quality and can be corrected with remedial measures).

 Critical (proof of serious non-conformities that have a critical influence on the

requirements or product quality).

INSPECTION REPORT

Describe how you document the inspection, the observations and the outcome in a report.
A report could contain:

 A summary of the processes inspected

 Detailed description and assessment of the observations

 Concluding assessment of the areas inspected

 Definition of corrective and preventive measures (incl. specific schedule)

Define who needs to sign the audit report, who will get copies and who will keep the
original (for how long).

CORRECTIVE/ PREVENTIVE ACTIONS - CAPA

Define how you will deal with irregularities and/or deficiencies including responsibilities.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting

ANNEX 1: CUSTOMER AUTHORIZATION AND SCHEDULING (EXAMPLE)

Self-Inspection for the Qualification of Customers

AUDIT CHECKLIST CAN BE DESIGNED ON THE LINES OF THE TRAINING

AUDIT CHECKLIST THAT IS PREPSRED, THIS IS JUST A SAMPLE.

GDP
Suggested Audit Questions Examples of Evidence
Section
Which authorities are relevant to your
customer base? Evidence of WDA(H)s available
How do you check that your customers and/or records of initial and ongoing
are bonafide? checks on relevant authorisation
websites eg CQC, GMC, MHRA
How regularly do you recheck?
Person being audited having
5.3 Pick a customer that you know knowledge of customer base and
receives pharma goods and use them as bonafide requirements
an example. Evidence of checks for unusual
Show me the customer qualification repetition of orders, sudden
for customer X, Y and Z increases of orders, and unusually low
Do you carry out any sales pattern prices
monitoring?
RP Job description with this
responsibility included and the RP
should be able to describe how they
How do you ensure that our customers
2.2 ensure that this responsibility is
are approved
fulfilled.
Evidence of any checking carried out
by the RP

Notes on Preparing a schedule:

Assessing processes risk to the business and/or assessing the criticality of the processes to
be audited will help to ensure a useful audit schedule designed not only to fit the
requirements of the guideline but to aid process improvement.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
Considering the business and quality objectives, process changes, previous audit non
conformities, relevant complaints and deviations, criticality of the process to product
quality/patient safety will help answer questions such as:
 How many times annually should this process be audited
 Who should be involved in the audits

A table and scoring system such as the one below may help:
1 – High, 2- Med, 3 - Low

Total
Criticality Previous Lowest
Relevance No. of Number of No. of
Process of the Internal =
Process to relevant relevant relevant
Reference process to Audit higher
Objectives changes complaints deviations
quality findings audit
priority
Personnel:
Competence,
SOP### 1 2 1 1 1 2 8
Awareness
and Training
Change
SOP### 2 1 1 1 3 1 9
Management
Material
SOP### 1 2 2 2 2 1 10
Storage

SOP### Validation 1 1 1 2 3 2 10

SOP### Complaints 1 2 1 3 1 3 11

Suspected
SOP### falsified 1 2 2 2 3 1 11
products
SOP### Transport 1 2 1 3 1 3 11
Corrective
and
SOP### 2 1 3 1 3 1 11
Preventative
Action
SOP### Returns 2 2 1 1 3 2 11
Information
Technology –
SOP### 1 2 3 2 3 1 12
back up
systems
Document
SOP### and Record 2 2 1 3 2 2 12
Management
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
Total
Criticality Previous Lowest
Relevance No. of Number of No. of
Process of the Internal =
Process to relevant relevant relevant
Reference process to Audit higher
Objectives changes complaints deviations
quality findings audit
priority
Housekeeping
SOP### and pest 2 2 2 2 3 1 12
control
Customer
SOP### 3 1 2 2 2 2 12
feedback
Management
SOP### Responsibility 2 1 3 2 2 2 12
and Review
Control and
Monitoring of
SOP### 1 2 3 1 3 2 12
measuring
devices
Customer
SOP### 1 2 2 3 3 2 13
Qualification
Self
Inspection
SOP### 2 1 3 3 1 3 13
and Internal
Audit
FSCA
SOP### Procedures 3 2 3 2 2 2 14
(recall)
Purchasing
SOP### and Supplier 1 2 3 3 2 3 14
Management
Product
Picking,
SOP### 1 2 2 3 3 3 14
Packing &
Despatch
Work
SOP### 2 2 3 3 3 2 15
Environment
Receiving
Goods –
SOP### 2 3 3 3 2 3 16
Goods
Inwards