What is GMP (Good Manufacturing Practice)? What is cGMP (Current Good Manufacturing Practice)? And how they are different are probably some of the most asked questions in the Pharma industry.
Are they both the same? Or is one just an upgraded version of the other?
In this article, let me attempt to give a clear picture of these two concepts and correlations between them by defining them clearly. Here we go!
What is GMP (Good Manufacturing Practice)?
Colloquially known as Good Manufacturing Practice regulations, GMP is a set of regulatory and quality conformance guidelines that are primarily applicable to pharma products, food, beverages, and cosmetics segments of manufacturing. GMP assures products manufactured in these industries are consistent as per the set quality standards, batch after batch and time after time.
It is important to note that GMP guidelines are not rigid regulations on how to manufacture, store and distribute products, but are general principles that must be observed by manufacturers to safeguard human lives.
Some of the key areas that GMP regulations cover include – manufacturing & storage, product testing, and quality assurance, personal qualifications, marketing & branding, etc. The primary objective is to make the manufactured product safe for human usage. This means to say that, GMP guidelines is not just applicable to the manufacturers, but also drug packagers, processors, storage companies, etc. and even to marketers.
Guidelines for GMP manufacturing companies are enforced by the Food and Drug Administration (FDA) under the title 21 CFR. However, many countries have brought into effect their own set of GMP guidelines for manufacturing units/companies falling under their legislation.
Non-conformance with GMP guidelines is considered by regulatory bodies as a serious offense and can result in recall or seizure of products, the imposition of heavy fines and in some worst cases even prison time.
GMP guidelines of some countries are flexible and open-ended because they allow the manufacturers to resolve to the implementation of quality controls while maintaining the goal of quality product outputs.
Important GMP Regulatory Guidelines
Although, GMP regulatory guidelines may vary significantly with countries, their common objective is to nullify any harm to the manufactured product’s end users. Here are some of the common sets of GMP guidelines that most of the regulatory bodies across the globe demand conformance with –
[Note that the list is just a representation for the guidelines and they need not be in the same legal language as mentioned in the GMP guidelines document of regulatory bodies.]
Production units or facilities should maintain hygiene all thorough their processes, including that of the production area, equipment, personal, packaging, etc.
Production of drugs should be carried out in controlled environmental conditions specified for the product. All production processes must be validated by qualified personal and machines to maintain product consistency and quality. In case of any changes to the process, the quality of the output must be verified before batch production.
Manufacturing facilities to take up measures to completely nullify or prevent any kind of cross contaminants (adulterants, allergens, chemicals, etc.) entering into processes from production to human consumption. This means to say, packaging of the product and direction for storage until its consumption is regulated by GMP guidelines.
Direction for the drug storage and usage by the end consumer must be mentioned in the packaging. The language must be explicit and definite.
Production units must document manually and electronically every step taken during drug production batch after batch. Information includes – procedures followed, quantity, quality, testing results (testing is usually done randomly), personnel information, etc. In case of deviation away from the norm during the production, a proper investigation should be conducted, documented and reported. Investigation documentation should also include measures taken to minimize deviations in future processes. In simple terms, anything and everything, including the final product should be traced back to its conceptualization.
All personnel must be trained to carry out documentation perfectly.
Manufacturers must take appropriate measures to store and distribute manufactured products with no risk to their quality. In case of any changes//deviations in quality, any stakeholder in the supply chain should be able to initiate a product recall.
What is cGMP?
Now that we have discussed GMP Guidelines, let us delve into cGMP to understand similarities and differences between them if at all any exist.
GMP itself is sometimes referred to as cGMP when ‘c’ stands for ‘Current’. The purpose of placing the word ‘Current’ is just to remind drug production units/companies that they have necessarily kept themselves updated to the latest GMP guidelines.
For example, there exist some GMP guidelines that may not be fit in this era, but it doesn’t mean companies can neglect them. The onus is on them to find the latest systems, technology, processes, etc. to make sure the objective of GMP conformance guidelines is met. No matter what!
The goal of any regulatory body is to achieve quality time and again. Same with regulatory bodies on food and drugs, their objective is to ascertain the production of products that are safe for human consumption. Hence GMP or cGMP guidelines exist across the globe, although varying in some aspects by country.