Jurisdiction.

Self Inspection and Quality audit:– It may be useful to constitute a self-inspection team supplemented with a quality audit procedure for assessment of all or part of a system with the specific purpose of improving it. 15.1 To evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control, concept of self-inspection shall be followed. The manufacturer shall constitute a team of independent, experienced, qualified persons from within or outside the company, who can audit objectively the implementation of methodology and procedures evolved. The procedure for self-inspection shall be documented indicating self-inspection results, evaluation, conclusions and recommended corrective actions with effective follow up program. The recommendations for corrective action shall be adopted. 15.2 The program shall be designed to detect shortcomings in the implementation of Good Manufacturing Practice and to recommend the necessary corrective actions. Self-inspections shall be performed routinely and on specific occasions, like when product recalls or repeated rejections occur or when an inspection by the licensing authorities is announced. The team responsible for self-inspection shall consist of personnel who can evaluate the implementation of Good Manufacturing Practice objectively; all recommendations for corrective action shall be implemented. 15.3 Written instructions for self-inspection shall be drawn up which shall include the following: - (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) 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) Labels control. (o) Results of previous self-inspections and any corrective steps taken.