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Chapter 8-Example-SOP-Template

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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.
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
VALIDITY/TRAINING
3
OBJECTIVES
3
AREA OF APPLICATION
4
AREAS OF RESPONSIBILITY
4
DEFINITIONS
4
DESCRIPTION OF THE SYSTEM USED TO IMPLEMENT SELFINSPECTIONS
5
INSPECTION PROGRAMME
7
AUDIT TEAM
8
INSPECTION PLAN (AGENDA)
8
ASSESSMENT OF OBSERVATIONS
9
INSPECTION REPORT
10
CORRECTIVE/ PREVENTIVE ACTIONS - CAPA
10
ANNEX 1: CUSTOMER AUTHORIZATION AND SCHEDULING
(EXAMPLE)
11
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
VALIDITY/TRAINING
Define when the SOP will be valid and who needs to be trained (incl. time frame).
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
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
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 SELFINSPECTIONS
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
INSPECTION PROGRAMME
Define how you set up your inspection programme with minimum timeframes. Define
how you will set the frequency.
Example clause:
An annual inspection programme that includes all of the areas mentioned must be issued.
The frequency of the inspections must be based on the quality status and current
compliance with the GDP rules (risk assessment). However each site must be inspected at
least once every year. GDP-QA is responsible for creating the inspection programme.
The Responsible Person approves it. The intervals and times must be coordinated with
the units/areas to be inspected.
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
ANNEX 1: CUSTOMER AUTHORIZATION AND SCHEDULING (EXAMPLE)
Self-Inspection for the Qualification of Customers
GDP
Section
5.3
2.2
Suggested Audit Questions
Examples of Evidence
Which authorities are relevant to your
Evidence of WDA(H)s available and/or
customer base?
How do you check that your customers records of initial and ongoing checks on
relevant authorisation websites eg CQC,
are bonafide?
GMC, MHRA
How regularly do you recheck?
Person being audited having knowledge
Pick a customer that you know receives of customer base and bonafide
pharma goods and use them as an requirements
example.
Evidence of checks for unusual
Show me the customer qualification for repetition of orders, sudden
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
How do you ensure that our customers should be able to describe how they
are approved
ensure that this responsibility is 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.
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
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
Process
Reference
SOP###
SOP###
SOP###
Process
Personnel:
Competence,
Awareness
and Training
Change
Management
Material
Storage
No. of
relevant
changes
Previous
Internal
Audit
findings
Number of
relevant
complaints
No. of
relevant
deviations
Total
Lowest
=
higher
audit
priority
2
1
1
1
2
8
2
1
1
1
3
1
9
1
2
2
2
2
1
10
Criticality
of the
process to
quality
Relevance
to
Objectives
1
SOP###
Validation
1
1
1
2
3
2
10
SOP###
Complaints
1
2
1
3
1
3
11
1
2
2
2
3
1
11
1
2
1
3
1
3
11
2
1
3
1
3
1
11
2
2
1
1
3
2
11
1
2
3
2
3
1
12
2
2
1
3
2
2
12
2
2
2
2
3
1
12
3
1
2
2
2
2
12
2
1
3
2
2
2
12
1
2
3
1
3
2
12
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
Suspected
falsified
products
Transport
Corrective
and
Preventative
Action
Returns
Information
Technology –
back up
systems
Document
and Record
Management
Housekeeping
and pest
control
Customer
feedback
Management
Responsibility
and Review
Control and
Monitoring of
measuring
devices
Possible content of a Standard Operating Procedure (SOP) for
Self-inspection: Performance, responsibility, reporting
Process
Reference
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
SOP###
Process
Customer
Qualification
Self
Inspection
and Internal
Audit
FSCA
Procedures
(recall)
Purchasing
and Supplier
Management
Product
Picking,
Packing &
Despatch
Work
Environment
Receiving
Goods –
Goods
Inwards
No. of
relevant
changes
Previous
Internal
Audit
findings
Number of
relevant
complaints
No. of
relevant
deviations
Total
Lowest
=
higher
audit
priority
2
2
3
3
2
13
2
1
3
3
1
3
13
3
2
3
2
2
2
14
1
2
3
3
2
3
14
1
2
2
3
3
3
14
2
2
3
3
3
2
15
2
3
3
3
2
3
16
Criticality
of the
process to
quality
Relevance
to
Objectives
1
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