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Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
In a good manufacturing practice regulated industry, the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to comprehend this concept. [13] [14] [15] As a common practice, the activity is usually directed by one or more SOPs. [16]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries , for example good agricultural practice , or GAP.
According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. [5]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects. [2] Food and Drug Administration inspectors often look at VMPs during audits to see whether or not a facility's validation strategy is well thought-out and organized.
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (Text with EEA relevance) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0 ...