QUALITY AUDIT AND GMP INSPECTION OF PHARMACEUTICAL INDUSTRY WITH REFERENCE TO USFDA; EMEA
Mathew George, Lincy Joseph, Ankit Anand, Kavitha
International Journal of Innovative and Applied Research
The objective of the present study was to identify the role of inspection in the quality management system, to review the way in which an inspection programme should be carried out and to discuss what to inspect and verify in a company's inspection system. The principle manufacturing and testing processes had been validated. All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records. Any planned changes in manufacturing,
... y control have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to and approval by the drug regulatory authority. Any additional sampling inspection, tests and checks have been carried out, as appropriate, to cover planned changes and deviations. All necessary production and quality control documentation has been completed and endorsed by supervisors trained in appropriate disciplines. Appropriate audits, self-inspections and spot-checks were carried out by experienced and trained staff. Approval has been given by the head of the quality control department. Audit and inspection are manufacturing facility in the pharmaceutical company. The international standard organization (ISO) has defined quality audit the most important functions of a as a "systemic and independent examination to determine whether quality activities and related result comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve." Self inspections should be conducted in order to monitor the implementation and the respect of good manufacturing practice (GMP) principles and propose necessary corrective measures. The reasons for quality audit are; 1. To initially evaluate the supplier where there is desired to establish a contractual relationship. 2. To verify that organization own quality system continues to meet specified requirement and its being implemented. 3. To evaluate an organization's own quality system against quality system standards. MECHANISM OF AUDITING Auditors proceed by using the audit plan or checklist as basis, by a) Asking question b) Reviewing documents c) Checking records against specs, making measurements, etc to ensure that all the audits teams have adequate documentation and are implemented in accordance with the documentation.