Pharmaceutical Plant Self-Inspection, Quality audits and Suppliers’ Audit Requirements as Per GMP

Self-Inspection and Quality audits

Earlier I have shared you the GMP Requirement for Pharmaceutical plant premises, Equipment’s, Production, Training and personnel Hygiene. There are various modules of GMP which I will share one after another & today’s module is Self-Inspection, quality audits and suppliers’ audit.

What is Self Inspection :

Self Inspection or Internal Audit is a Quality System to check whether activities followed by all departments are according to the written approved procedures and complying with the cGMP and Regulatory Requirements.

For Self Inspection pl Refer :

The purpose of self-inspection is to evaluate the manufacturer’s or the plants compliance with GMP in all aspects of production, Quality assurance 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, e.g. in the case of product recalls or repeated rejections, or when an inspection by the health authorities is announced. The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP . 

All recommendations for corrective action should be implemented.

The procedure for self-inspection should be documented, and there should be an effective follow-up programme.

Written instructions for self-inspection should be established to provide a minimum and uniform standard of requirements. These may include questionnaires on GMP requirements covering at least the following items:

(a) Personnel;

(b) Premises including personnel facilities;

(c) Maintenance of buildings and equipment;

(d) Storage of starting materials and finished products;

(e) Equipment and instruments

(f) Production and in-process controls;

(g) Quality control

(h) Documentation;

(i) Sanitation and hygiene;

(j) Validation and revalidation programmes;

(k) Calibration of instruments or measurement systems;

(l) Recall procedures;

(m) complaints management;

(n) Results of previous self-inspections and any corrective steps taken.

Self-inspection Team :

Management should appoint a self-inspection team consisting of experts in their respective fields who are familiar with GMP. The members of the team may be appointed from inside or outside the company.

Frequency of self-inspection :

The frequency with which self-inspections are conducted may depend on company requirements but should preferably be at least once a year. The frequency should be stated in the procedure.

Self-inspection Reports :

A report should be made at the completion of a self-inspection. The report should include:

(a) self-inspection results;

(b) Evaluation and conclusions;

(c) Recommended corrective actions.

There should be an effective follow-up programme. The company management should evaluate both the self-inspection report and the corrective actions as necessary.

Quality Audits :

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 the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors.

The contract giver shall performed audit at contract acceptors site periodically or before giving contract for manufacturing of products.

Suppliers’ audits and Approval :

The person responsible for QA or CQA should have responsibility, together with other relevant departments, for approving suppliers who can reliably supply Raw 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 should take into account a supplier’s 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.


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