Laboratory controls Good Manufacturing Practice

Quality Control Records. Accurate quality control records are of utmost importance and may be required by law, as in the pharmaceutical industry. A few years ago, mandatory Good Manufacturing Practices were proposed for the cosmetic industry. Although the proposal was later dropped, many manufacturers go by the rules worked out at that time for laboratory testing and record keeping. The food industry also requires extensive testing and record keeping. 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Finally, radiopharmaceuticals are often prepared on a daily basis within the framework of clinical studies which often last several months or years. They demand a viable and reproducible production chain, leading to a sterile- and pyrogen-free radiopharmaceutical of high radiochemical purity. Therefore, microprocessor-controlled automated synthesis devices [31] are developed in order to ensure routine pharmaceutical production. They are becoming mandatory in order to meet the demands related to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). 

Code of Federal Regulations, Title 21,Food and drugs,Part 211,Current good manufacturing practice for finished pharmaceuticals, Subpart I, Laboratory controls, Section 211.166, Stability testing. 

Currently, the CFR Title 21, Current Good Manufacturing Practice (cGMP), part 211, subpart I, entitled Laboratory Controls, section 211.165(e) states that the accuracy, sensitivity, specificity and... 

DIOGENES also provides access to many other FDA regulatory documents related to quality control and standards for good manufacturing or laboratory practices. These will be discussed in greater detail later in this chapter. 

All Production, Quality Control and Laboratory personnel and all other personnel (e.g. maintenance, service and cleaning staff) whose duties take them into manufacturing areas, or which bear upon manufacturing activities, should be trained in the principles of Good Manufacturing Practice and in the practice (and the relevant theory) of the tasks assigned to them. 

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