Introduction
The pharmaceutical industry is strictly regulated, mainly by the legal authorities of their respective countries. Pharma product manufacturers must adhere to relevant market regulations in which they plan to manufacture or market their products. Every country or region has regulations, including the GMP –Good Manufacturing Practices. These practices are the guidelines for pharma manufacturers that manufacture or market their products in the United States of America. They are put into law by the Food and Drug Administration – FDA.
What is the definition of GMP?
There is no specific definition of a GMP. However, the FDA website states that GMP regulations for a pharma drug contain minimum requirements for methods, facilities and control used in manufacturing, processing and packing. The regulation's main aim is to ensure the product is safe for human use. Additionally, it contains the desired ingredients and strength as per the claim.
GMP has the status of law and focuses on quality in the final finished drug. Quality ensures the final product is safe from errors, contamination and mix-up.
Some areas of the pharma industry that address GMP regulations include documentation, personal expertise and qualification, cleanliness, equipment and process validation. It is the responsibility of individual pharma manufacturers to interpret this regulation according to its requirements and implement it in a way that benefits its customer and simultaneously fulfils regulatory requirements.
If any pharma manufacturer fails to comply with the cGMP regulations, it can result in warnings, fines and even shutting down manufacturing operations.
Importance of cGMP manufacturing
Let’s look at some importance of GMP in pharma manufacturing and see how it benefits the pharma manufacturer
Compliance
Implementation of GMP guidelines ensures FDA compliance for a pharma manufacturer. It allows them to market and sell their products in the United States market. It prevents the pharma manufacturer from receiving warnings, fines or shutting down manufacturing operations from the FDA.
Products Safety
Complying with all the GMP requirements induces quality in the entire product life cycle - from start to finish, ultimately producing quality in the final product. Because quality cannot only be included in the
Customer Trust
Adherence to GMP regulations creates trust in the customer's mind, increasing the pharma manufacturer's credibility and market share. It makes the customer confident they get the right value for the money spent.
Buildings and Equipment are in right condition
GMP regulations cover the entire aspects of pharma manufacturing, including the building and equipment. These directly impact product quality and safety. Following all GMP regulations ensures that equipment and building are maintained according to the product’s production requirements, quality is maintained, and drugs deliver the required therapeutic effects.
Process Credibility
GMP regulations also focus on processes involved in product manufacturing. It ensures process credibility by implementing appropriate documentation, validation activities and quality testing at various stages. These help in creating and maintaining process credibility throughout the entire production cycle.
FDA regulations for cGMP
Let’s discuss some regulations of GMP in pharmaceutical industry
21 CFR Part 314 – For FDA approval to market a new drug.
21 CFR part 314 is the FDA regulations regarding “Application for FDA approval to market a new drug”. These regulations cover requirements set forth by the FDA under section 505 and do not cover regulations covered under the “Public Health Service Act” section. These regulations facilitate the approval of safe and effective drugs while also disapproving unsafe and ineffective drugs.
Some important points under 21 CFR part 314 include the following.
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