Good Manufacturing Practices

Good Manufacturing Practices

Non ISO STANDARDS

The practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good Manufacturing Practices, along with Good Laboratory Practices and Good Clinical Practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.

Good Manufacturing Practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation

Benefits of Good Manufacturing Practices

  • Increased customer's long-term confidence in the enterprise
  • Timely detection of production and management problems
  • Decreased safety risk in product quality and safety
  • Understanding and compliance with the relevant laws and regulations

Principle of Good Manufacturing Practices

  • Hygiene
  • Controlled environmental conditions
  • Clearly defined and controlled manufacturing processes
  • Clear instructions and procedures written in unambiguous language
  • Trained operators are to carry out and document procedures
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.