Before you start working with anything related to Pharmaceuticals you don’t think about how actually they produce or manufacture the drugs that you might take on a day to day basis. However, it is always interesting to understand how things happen behind closed doors and what kind of procedures or rules companies and their workforce have to follow in order to produce quality products. I did my homework and researched some of the basic concepts that Pharmaceutical or even Food manufacturers have to follow.
What is GMP?
GMP refers to the Good Manufacturing Practice Regulations enforced by regulatory agencies according to each country’s regulatory agency to control authorization and licensing. These regulations require the manufacturers, processors and packagers of drugs, medical devices, some food and blood take proactive steps to ensure that their products are safe, pure and effective.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups or errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling.
How GMP acts within Pharmaceuticals?
It is designated to minimize the risks involved in any Pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean the patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed and documented and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines.
GMP is necessary even if there is a Quality Control Laboratory as good quality must be built in during the manufacturing process to prevent errors that cannot be eliminated through quality control of the finished product. Without GMP is impossible to be sure that every unit of medicine is of the same quality as the units of medicine tested in the laboratory.
GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP.
GMP Guideline versions
GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA) under the title 21 CFR.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide.
The European Union guidelines are detailed in Eudralex – Volume 4 and enforces similar requirements to WHO GMP as does the FDA’s version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines, and Vietnam.
In the United Kingdom, the Medicines Act (1968) covers most aspects of the GMP 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.
Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.) and applies in other countries (e.g. Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.
Regulatory Authorities performs GMP inspections (to name a few)
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
EMA – European Medicines Agency (EU)
FDA – US Food and Drug Administration (USA)
Health Canada (Canada)
TGA – Therapeutic Goods Administration (Australia)
Japanase PMDA – Pharmaceutical and Medical Devices Agency (Japan)
Chinese Authorities - State Food and Drug Administration, P.R. (China)
MPA – Medicinal Products Agency (Sweden)