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Key Industry Requirements |
The Pharmaceutical and related Process Industries are some of the most regulated in the world.
Pharmaceutical Industry self-regulation is no longer an option as federal and non-governmental bodies take increasing interest in the activities of pharmaceutical companies.
Investigations seem to uncover case upon case of compliance violations followed by costly settlement negotiations and loss of consumer confidence. In the wake of highly visible investigations and lawsuits, national, international and multi-national governing bodies have leveraged an influx of increasingly stringent and ever-changing guidelines.
The key industry requirements for the Pharmaceutical Industry include GxP guidelines and FDA regulations.
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• GxP guidelines
The purpose of the GxP quality guidelines is to ensure that a product is safe and meets its intended use.
GxP guides quality manufacturing in regulated industries including food, drugs, medical devices and cosmetics.
The key concept of GxP are:
• Traceability: the ability to reconstruct the development history of a drug or medical device.
• Accountability: the ability to resolve who has contributed what to the development and when.
Documentation is a critical tool for ensuring GxP adherence.
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• FDA regulations
The FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety.
The FDA regulation of cosmetics is focused primarily on labeling and safety.
The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.
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• 21 CFR Part 11
Title 21 CFR Part 11 deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signature.
Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
Part 11 requires drug manufacturers, medical device manufacturers, biotech companies, biologics developers and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.
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• Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices.
GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.
Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
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