Various types of validation are required throughout the drug product development and manufacturing lifecycle. In this post, we'll explore the key types of validation in the pharmaceutical industry.
Regulatory agencies not only require life sciences companies to produce a product that meets its specifications but also demand that the processes, procedures, and activities performed during the manufacturing of that product generate reproducible results that meet stringent quality standards. This is achieved through validation.
The FDA defines validation as "establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes."
Cleaning Validation
If you're producing pharmaceuticals, vaccines, or other regulated products, an effective cleaning validation program is critical to your manufacturing process. Inadequate cleaning of contact surfaces, packaging, and equipment can contaminate products, leading to production delays, product waste, FDA 483 observations, and costly regulatory citations.
Title 21 Code of Federal Regulations (CFR), Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals governs cleaning validation compliance for pharmaceutical products in the United States. The European Medicines Agency (EMA), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and a host of other regulatory organizations have released similar cleaning validation guidelines.
Equipment and Instruments Qualification and Validation
Regulatory guidelines dictate that the equipment and instruments used to manufacture regulated products, such as APIs and finished pharmaceutical drugs, must be qualified to ensure the products are made in a safe environment. Equipment qualification and validation (EQV) is a complex process.
Drug companies must prove the equipment and instruments used during manufacturing were correctly installed, work properly, and will produce the expected results consistently. The complexity of drug manufacturing makes this a monumental task. Labs are filled with instruments of all types, and each piece of equipment comes with its own validation protocols.
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