Good Manufacturing Practice validation

Supplementary guidelines on good manufacturing practices validation... 

World Health Organization. Analytical method validation. In Supplementary guidelines on good manufacturing practices validation. Appendix 4. Technical Report Series, Annex 4, No. 937. Geneva WHO 2006. 

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

Since the U.S. vs. Barr decision in 1993 (relevant to pharmaceuticals and related fields, rules applied by the Federal Food Drug Administration, FDA), outlier tests may no longer be applied to physicochemical tests, under the assumption that such test methods, having been optimized and validated for the particular set of circumstances, rarely produce outliers. These tests may not be applied to CU results at all. Good manufacturing practices mandate that operators work according to pre-set procedures and write down any observed irregularities as they... 

Why do we have to worry about method validation in the first place The most compelling reason is that the law requires it. Title 21, Part 211 of the Code of Federal Regulations on Current Good Manufacturing Practice for Finished Pharmaceuticals states ... 

Validation itself is considered a required part of good laboratory practice (GLP) and good manufacturing practice (GMP) within any pharmaceutical laboratory and has been defined by the FDA as ... 

In pharmaceutical manufacturing, process validation is an exercise that requires the contribution from different departments, including quality assurance and quality control. It is a requirement for good manufacturing practice (GMP) to ensure that the final product produced is of the expected quality. 

Current good manufacturing practices (GMPs) have been established all over the world. The GMPs basically serve as guidelines but do not provide step-by-step directions on how to achieve them. However, the validation master plan and associated SOPs exactly define responsibilities who, when, where, and how much is sufficient to demonstrate. 

Record keeping is a prime requirement of current good manufacturing practices. The records required for a validated steam sterilization cycle are listed below ... 

In addition to the somewhat empirical and difficult development of NIR applications, thorough documentation must be produced. NIR methods have to comply with the current good manufacturing practice (cGMP) requirements used in the pharmaceutical industry. Various regulatory aspects have to be carefully considered. For example, NIR applications in classification, identification, or quantification require extensive model development and validation, a study of the risk impact of possible errors, a definition of model variables and measurement parameters, and... 

World Health Organization (WHO) (2006), WHO expert committee on specifications for pharmaceutical preparations (fortieth report)—Supplementary guidelines on good manufacturing practices (GMP) Validation, WHO, Geneva. 

U.S. Food and Drug Administration (FDA) (2002), general principles of software validation, good manufacturing practices, Rockville, MD. 

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