Good Laboratory Practices for Pharmaceutical Quality Control Laboratories

Industrial Management Consulting
Industrial Management Consulting

  1. 1. Good Laboratory Practices
  2. 2. – Introduction – Requirements of GLP – Stepwise GLP in QC – Audit Findings – Issues due to not following GLP – Future Trends in GLP Contents
  3. 3. Introduction
  4. 4. Introduction • Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. • GLP data are intended to promote the quality and validity of test data. • Weller gave an excellent practical explanation on what is expected from working in a regulated environment: “If experimental work is conducted in compliance with GLP, with or without the aid of computer, it should be possible for an inspector, maybe four or five years hence, to look at the records of the work and determine easily why, how and by whom the work was done, who was in control, what equipment was used, the results obtained, any problems that were encountered and how they were overcome”.
  5. 5. Introduction • Good laboratory practice requires testing normal and abnormal controls for each test atleast daily to monitor the analytical process. For the quality of a medicine sample to be correctly assessed: • The submission of a sample of an API, excipient or pharmaceutical product or a suspected counterfeit material to the laboratory, selected in accordance with national requirements, should be accompanied by a statement of the reason why the analysis has been requested. • The analysis should be correctly planned and meticulously executed. • The results should be competently evaluated to determine whether the sample complies with the specifications or other relevant criteria.
  6. 6. Introduction • Regulatory requirements, inspection and enforcement practices are quite dynamic. What is appropriate today may not need to be appropriate tomorrow. Regulations change but more often it is the inspection practices that change. • In the early 90’s the focus of inspections was on basic requirements of GLP and GMP, but then it changed to equipment hardware and later on to software and computer systems. • Today, the clear focus is on Quality control, Microbiology, Laboratory controls, data security, traceability and integrity of electronic records, driven mainly but not only by FDA’s regulation 21 CFR Part 11.

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