Self-inspection and internal audits in Pharma according to different guideline

In different Pharma guideline information is given about the self inspection and internal audit.

Following are the different prospective for self inspection given in different guideline:

According to WHO TRS (Series, No. 908):

The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control. The self-inspection programme should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-inspections should be performed routinely, and may be, in addition, performed on special occasions

According to ICH Q7:

2.40 In order to verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule.

2.41 Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.

According to EU GMP:

Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

9.1 Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.

9.2 Self inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful.

9.3 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.

29.11 Self inspection:

(a) Short description of the self inspection system indicating whether an outside, independent and experienced external export was involved in evaluating the manufacturer compliance with Good manufacturing Practices in all aspects of production.