Hong Kong Guide to Good Manufacturing Practice for the Secondary ...

12. SELF INSPECTION
12.1 Self inspections should be conducted in order to monitor the implementation and
compliance with the requirements of this Guidance Document and to propose necessary
corrective measures.
12.2 Personnel matters, premises, equipment, documentation, assembly, quality control,
distribution of the pharmaceutical products, arrangements for dealing with complaints
and recalls should be examined at intervals following a pre-arranged program.
12.3 Self inspections should be conducted in an independent and detailed way by designated
competent persons. Independent audits by external experts may also be useful.
12.4 All self-inspections should be recorded. Reports should contain all the observations made
during the inspections and, where applicable, proposals for corrective measures.
Statements on the actions subsequently taken should also be recorded.
13. CONTRACT PACKAGING OR ANALYSIS ARRANGEMENTS
13.1 Where secondary packaging or analysis of pharmaceutical products is carried out under
contract, a written contract agreement between the Contract Giver and the Contract
Receiver should be available to describe the arrangements and responsibilities of both
parties.
13.2 The arrangements and responsibilities for any contracted activities should be consistent
with the requirements of Chapter 7 of the PIC/S GMP Guide.
Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 14