May 13, 2023 | Pharmaceuticals
Following Good Manufacturing Practices (GMPs) is the bare minimum that needs to be followed in any pharmaceutical contract manufacturing company to ensure quality production. Proactive testing and regular monitoring of all the processes form a crucial aspect of a manufacturing firm, bereft of which best quality deliverable may take a back seat. Give this blog a read to know how these two aspects affect manufacturing outcomes.
It encompasses testing at different stages of production so that there is no scope for any error to crop up. Stability testing is one such way by which pharmaceutical manufacturers can ensure that the quality of the product is up to the mark. It is needed for regulatory approvals also. The product only gets approval for commercialization when it passes the prescribed quality standard under different circumstances. Accelerated, intermediate, and long-term stability tests are performed under this protocol.
Any change in the quality of Active Pharmaceutical Ingredient (API) or Final Product (FP) can be captured if these tests are made a mandatory practice. Such tests ensure that the product composition is intact physically, biologically, and chemically. Long-term stability testing conditions depend on the climatic zone where the manufacturing unit is located. There are specialized chambers to conduct such tests. These are referred to as stability chambers. These come in various sizes catering to the scale of production.
Pharmaceutical manufacturers need to monitor storage conditions at all times as even a minute change in temperature and humidity can alter the chemical properties of medications, thereby rendering them unfit for prospective usage. Such system failures account for a great loss of finance, resources, time, and labor. In addition, incidents like these have a long-lasting impact on the consumer psyche. Brand trust takes time to build up but is fragile enough to be shattered and there is no reason why that should not be the case as it is health that is at stake (in extreme cases, life).
With bigger manufacturing capacity comes an even bigger responsibility. An unparalleled player in pharma manufacturing is Akums Drugs & Pharmaceuticals Ltd. It has been delivering the highest quality products to its partner companies for about two decades. Relying on third-party pharma manufacturing that has top-quality certifications and export accreditations is the best way pharmaceutical companies can offer high-grade products to their customers.
Last but not the least, who would want to be issued the FDA 483 form? You guessed it right: no one. This makes it all the more important to comply with the set rules and regulations.