Professional Documents
Culture Documents
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 SELF-
INSPECTIONS 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).
AREA OF APPLICATION
Define all areas to which this SOP applies to (departments, sites, regions).
AREAS OF RESPONSIBILITY
Planning self-inspections
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
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:
Hygiene rules
Processing recalls
Handling complaints
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.:
AUDIT TEAM
Describe role and responsibilities of lead auditor, co-auditor and the (local) quality
assurance.
Define how you set up your set inspection plan (agenda) for the self-inspection.
An inspection plan could cover:
Name of area/unit
Inspection date
Schedule
Critical1
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.
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:
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).
INSPECTION REPORT
Describe how you document the inspection, the observations and the outcome in a report.
A report could contain:
Define who needs to sign the audit report, who will get copies and who will keep the
original (for how long).
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
GDP
Suggested Audit Questions Examples of Evidence
Section
Which authorities are relevant to your
customer base? Evidence of WDA(H)s available and/or
How do you check that your customers records of initial and ongoing checks on
are bonafide? relevant authorisation websites eg CQC,
GMC, MHRA
How regularly do you recheck?
Person being audited having knowledge
5.3 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
2.2
are approved ensure that this responsibility is fulfilled.
Evidence of any checking carried out by
the RP
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
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
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
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
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