Basic Principles of GMP: Self-Inspection

Basic Principles of GMP
Self-Inspection
Module 7
Slide 1 of 17
WHO - EDM
Self-Inspection
Objectives
To identify the role of self-inspection in the

quality management system.
To review the way in which a self-inspection

programme should be carried out.
To discuss what to check in a companys selfinspection.
Module 7
Slide 2 of 17
WHO - EDM
Self-Inspection
Principle - I
Ensures that a companys operations remain compliant

with GMP
Assists in ensuring continuous quality improvement
Should
cover all aspects of production and quality control
be designed to detect shortcomings in the implementation
of GMP
Must
recommend corrective action if shortcomings are observed
set a timetable for corrective action to be completed
Part One 9.1
Module 7
Slide 3 of 17
WHO - EDM
Self-Inspection
Principle - II
Special occasions may demand additional selfinspections. For example
Recalls
Repeated rejections
GMP inspections announced by the National

Drug Regulatory Authority
Part One 9.1
Module 7
Slide 4 of 17
WHO - EDM
Self-Inspection
Principles III
Team consist of personnel who can evaluate the

situation objectively
No conflict of interest
No revenge in mind
Should have experience as observers of a selfinspection team before becoming team member
Lead self-inspector with experience as team

member
Part One 9.1
Module 7
Slide 5 of 17
WHO - EDM
Self-Inspection
1. Self-inspection - informal
(daily)
Immediate Correction
2. Self-inspection - formal
(quarterly)
3. QC - Internal
Improve systems
Confirm compliance
(half yearly)
Module 7
Slide 6 of 17
WHO - EDM
Self-Inspection
Scope of Self-Inspection Programme - I
Written instructions
Covering all aspects of GMP:
personnel
premises including personnel facilities
maintenance of buildings and equipment
storage of starting materials and finished products
equipment
production and in-process controls
quality control
Part One 9.2
Module 7
Slide 7 of 17
WHO - EDM
Self-Inspection
Scope of Self-Inspection Programme - II
documentation
sanitation and hygiene
validation and revalidation programmes
calibration of instruments or measurement systems
recall procedures
complaints management
labels control
results of previous self-inspections and
any corrective steps taken
Module 7
Slide 8 of 17
Part One 9.2
WHO - EDM
Self-Inspection
The Self-Inspection Team
Team leader needs:

authority
experience
may be appointed from inside or outside the company
Team members, including:

local staff who are familiar with the area
experts in their own field
familiar with GMP
may be appointed from inside or outside the company
Part One 9.3
Module 7
Slide 9 of 17
WHO - EDM
Self-Inspection
Carrying Out a Self-Inspection
Frequency
May depend on company requirements and the size of the
company
Report:
results
evaluation
conclusions
recommended corrective measures, if applicable
Follow-up action
Company management must evaluate both
the report and corrective actions
Module 7
Slide 10 of 17
Part One 9.4 9.6
WHO - EDM
Self-Inspection
Quality Audit
GMP Inspectors should encourage Quality Audits
Useful to supplement self-inspection programme

but not mandatory
Examination of all or part of quality system with

specific aim of improving it
Usually conducted by outside experts or team

appointed by management
May extend to suppliers and contractors

Part One 9.7
Module 7
Slide 11 of 17
WHO - EDM
Self-Inspection
Suppliers audits
QC department should have responsibility together with

other relevant departments for approving suppliers
Ensures suppliers can reliably supply materials that

meet established specifications
Avoids trying to test in quality to goods received from

dubious sources
Before suppliers are approved they should be evaluated
Evaluation does not necessarily mean an audit
Should take into account the suppliers

history and nature of materials to be supplied.
Module 7
Slide 12 of 17
Part One 9.8 9.9
WHO - EDM
Self-Inspection
Auditing the Self-Inspection Programme
-I
Check self-inspection programme at end of

formal government GMP inspection, not at
beginning.
GMP inspectors should assess:

the SOP
programmes
checklists or aide memoirs
Module 7
Slide 13 of 17
WHO - EDM
Self-Inspection
Auditing the Self-Inspection Programme - II
The SOP should describe teams, process, and

frequency of self inspection.
Company policy may not permit GMP inspector to

see actual deficiency reports and corrective
actions.
GMP Inspectors should be looking for compliance

with the self-inspection SOP - not necessarily at
actual deficiencies recorded.
Seek objective evidence of reports and action.
Module 7
Slide 14 of 17
WHO - EDM
Self-Inspection
Auditing the Self-Inspection Programme
- III
Ensure company is not just doing

housekeeping or safety audits
Check there are Vertical as well as normal

Horizontal audits; both play valuable role in
self-inspection
Part One 9.4 9.6
Module 7
Slide 15 of 17
WHO - EDM
Self-Inspection
Group Session
You are a GMP inspector in a large company

with a diverse range of products
You are given the SOP, deficiency report form,

and the self-inspection schedule
Prepare a report of your observations as to

whether the companys approach to selfinspection meets GMP guidelines
Module 7
Slide 16 of 17
WHO - EDM
Self-Inspection
Possible Issues
Size of the factory; phased inspection
Source of team leader
Source of team members
Reports and feedback
Module 7
Slide 17 of 17
WHO - EDM

Basic Principles of GMP: Self-Inspection

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Basic Principles of GMP

To identify the role of self-inspection in the

To review the way in which a self-inspection

To discuss what to check in a companys selfinspection.

Ensures that a companys operations remain compliant

Assists in ensuring continuous quality improvement

Part One 9.1

GMP inspections announced by the National

Team consist of personnel who can evaluate the

Lead self-inspector with experience as team

Covering all aspects of GMP:

Part One 9.2

Team leader needs:

Team members, including:

Part One 9.4 9.6

GMP Inspectors should encourage Quality Audits

Useful to supplement self-inspection programme

Examination of all or part of quality system with

Usually conducted by outside experts or team

May extend to suppliers and contractors

QC department should have responsibility together with

Ensures suppliers can reliably supply materials that

Avoids trying to test in quality to goods received from

Before suppliers are approved they should be evaluated

Evaluation does not necessarily mean an audit

Should take into account the suppliers

Part One 9.8 9.9

Check self-inspection programme at end of

GMP inspectors should assess:

The SOP should describe teams, process, and

Company policy may not permit GMP inspector to

GMP Inspectors should be looking for compliance

Seek objective evidence of reports and action.

Ensure company is not just doing

Check there are Vertical as well as normal

Part One 9.4 9.6

You are a GMP inspector in a large company

You are given the SOP, deficiency report form,

Prepare a report of your observations as to

Size of the factory; phased inspection

Source of team leader

Source of team members

Reports and feedback

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