Current Good Manufacturing Practice (GMP) in the pharmaceutical and medical device industry is a Food and Drug Agency (FDA) mandated requirement to ensure all production activities are executed by trained operatives following pre-approved documented procedures that utilize only fully validated and calibrated equipment, facilities and utilities. (21 CFR Part 820/210/211/11 Refers.)
FDA regulations use the phrase "current good manufacturing practices cgmp's" (GLP/GMP Validation) to describe these guidelines. Courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards. By June 2010, the same GLP/GMP Validation requirements will apply to all manufacturers of dietary supplements. The World Health Organization (WHO) version of cGMP Validation is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's cGMP (EU-GMP) enforces similar requirements to WHO cGMP Validation, as does the Food and Drug Administration's version in the US. Similar cGMP Validations are used in other countries, with Australia, Canada, Japan, Singapore and others having highly developed/sophisticated cGMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of cGMP in what is commonly referred to as "The Orange Guide", which is named so because of the colour of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
Current Manufacturing Practices (for medicinal products) is that part of Quality Assurance which ensures that Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification. cGMP is concerned with both production and quality control.
Current Good Manufacturing Practice cGMP, are issued by regulatory authorities throughout the world, country by country and region by region. In general they list minimum standards for the safe manufacture, storage and distribution of medicinal drugs, devices and all associated records. GMP rules and FDA regulations are just as enforceable (in the country of their origin) as is common criminal law. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations between manufacturing companies has led to national authorities introducing commonality in many specifications and standards; this is a continuous and ongoing process.
There are several different sections to GLP/GMP Validation requirements as detailed in CFR’s so it is essential to study those applicable to your processes. I.E. Medical Device, Biotech, Human Food, or Drugs. Manufacturers must adapt a very positive and proactive approach in conforming and enforcing the rules and guidelines throughout their entire manufacturing, inspecting, storing and distribution processes. They are required to implement processes and procedures that comply with the requirements listed in the applicable continued Good Manufacturing Practices (cGMP) and gain approval from their regulatory authority that they comply with all of these regulations prior to being allowed to release their produce for public or prescribed use. They are subject to continuous monitoring of this regulated state.
Good Manufacturing Practices cGMP and FDA regulations have been developed to ensure that medicinal pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use. They have been developed and introduced in 1962 in response to the US public’s concern about the safety, efficacy and overall quality of drugs. In the United States the regulations are called cGMP to take into account that the regulations are not static but rather dynamic. They are defined in Title 21 of the U.S. Code of Federal Regulations: 21 CFR 210 – current Manufacturing Practice for drugs in general and 21 CFR 211 – Current Manufacturing Practice, for finished pharmaceuticals. In 1996 the FDA proposed a significant revision of the regulation. Any drug marketed in the US must first receive FDA approval, and must be manufactured in accordance with the US cGMP regulations. Because of this, FDA regulations have set an international regulation benchmark for pharmaceutical manufacturing.
In Europe local Good Manufacturing Practices cGMP, regulations exist in many countries. They are based on the European Union (EU) directive: Manufacturing Practice for Medicinal Products in the European Community. This EU GMP is necessary to permit free trade in medicinal products between the member countries. Regulations in the EU allow for the marketing of a new drug in the twelve member countries with a single marketing approval.
The EU GMP is intended to establish a minimum manufacturing standard for all member states. The EU directive has been widely harmonized with the Guide to current excellent Manufacturing Practice for Pharmaceutical Products as developed by the Pharmaceutical Inspection Convention (PIC).10
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The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. It must mandate the production of all Practices and Procedure manuals and SOP's.
The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes. It is a master reference for all validation variables and queries.
When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities. This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance rulings.
During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task. The use and scope of the individual documents has been documented, discussed and explained in detail. It is therefore obviously best policy to have in place exactly what the regulator is looking for. The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated