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

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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

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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

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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

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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

Implementation.pdf
b. Aide-Memoire Cross-Contamination in Shared Facilities.pdf
c. Aide-Memoire GMP Inspection Related to Packaging.pdf
d. Aide-Memoire Inspection of Pharmaceutical Quality Control
Laboratories.pdf
e. Aide-Memoire Inspection of Utilities.pdf

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REFERENCES

• https://picscheme.org/en/picscheme. PE 009-
15 (Part I)
• Annex 2, WHO Good Manufacturing Practices
for Pharmaceutical Products: Main Principles
• Aide-Memoire, PIC/S.

THANK YOU