Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Regulatory authorities including the EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistently high quality biopharmaceutical products that are safe and efficacious and fit for their intended purpose.. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by quality control testing. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification.
GRA is experienced in assisting in:
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