8. Self-Inspection, Quality Audits and Supplier's Audits and Approval
8.1 Principle. The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and QC. 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 objectively. 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.
Items For Self-Inspection:
8.2 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;
(f) Production and in-process controls;
(g) QC;
(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) Labels control;
(o) Results of previous self-inspections and any corrective steps taken.
Self-Inspection Team:
8.3 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:
8.4 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 Report:
8.5 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.
Follow-Up Action:
8.6 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 Audit:
8.7 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 (see section 7, “Contract production and analysis”).
Suppliers’ Audits and Approval:
8.8 The person responsible for QC should have responsibility, together with other relevant departments, for approving suppliers who can reliably supply starting and packaging materials that meet established specifications.
8.9 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.
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
