12/27/2021
Self-Inspection
Dr. Wan Maznah Wan Ishak
Pn. Rohani Mohammad
AP Ts Dr Raihana Edros
PRINCIPLE
• Self-inspection should be conducted to monitor the
implementation and compliance with GMP principles and to
propose necessary corrective measures
• Self-inspections should be performed:
✔ routinely
✔ special occasions eg, in the case of product recalls or
repeated rejections
✔ inspection by the health authorities
PIC/S : PE 009-15 (Part I)
9.1
1
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PRINCIPLE
• Self-inspection should be conducted in an independent and
detailed way by designated competent person from the company.
• Independent audits by external experts may also be useful
• All self-inspections should be recorded
• Reports should contain all observations made by during the
inspections and proposals for corrective measures
• Statements on the actions subsequently taken should also be
recorded
PIC/S : PE 009-15 (Part I)
9.2 – 9.3
ITEMS FOR SELF-INSPECTION
❖ Personnel
❖ Premises including personnel facilities
❖ Maintenance of buildings and equipment
❖ Storage of starting materials and finished products
❖ Equipment
❖ Production and in-process controls
❖ QC
❖ Documentation
❖ Sanitation and hygiene
WHO, Annex 2
8.2
2
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ITEMS FOR SELF-INSPECTION
❖ 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
WHO, Annex 2
8.2
SELF-INSPECTION REPORT
• The report should be made at the completion of a self-inspection
and include:
❖ self-inspection results
❖ evaluation and conclusions
❖ recommended corrective actions
WHO, Annex 2
8.5
3
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FOLLOW-UP ACTION
• There should be an effective follow-up programme.
• The company management should evaluate both self-inspection
report and corrective actions
WHO, Annex 2
8.6
QUALITY AUDIT
• It may be useful to supplement self-inspections with a quality
audit.
• A quality audit consists of an examination and assessment of all or
part of a quality system with specific purpose of improving it
• A quality audit usually conducted by outside or independent
specialists or a team designated by the management
• Such audits may also ben extended to suppliers and contractors
WHO, Annex 2
8.7
4
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SUPPLIER’S AUDIT AND
APPROVAL
• The person responsible for QC should have responsibility with
other departments for approving suppliers who can reliably supply
starting and packaging materials that meet established
specifications
• Before suppliers are approved and included in the approved
suppliers’ list or specifications, they should be evaluated.
• The evaluation take into account a suppliers’ history and the
nature of the materials to be supplied.
• If an audit is required, it should determine the supplier’s ability to
conform with GMP standards WHO, Annex 2
8.8 – 8.9
AIDE MEMOIRE
a. Aide-Memoire Assessment of Quality Risk Management
[Link]
b. Aide-Memoire Cross-Contamination in Shared [Link]
c. Aide-Memoire GMP Inspection Related to [Link]
d. Aide-Memoire Inspection of Pharmaceutical Quality Control
[Link]
e. Aide-Memoire Inspection of [Link]
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REFERENCES
• [Link] PE 009-
15 (Part I)
• Annex 2, WHO Good Manufacturing Practices
for Pharmaceutical Products: Main Principles
• Aide-Memoire, PIC/S.
THANK YOU