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Process Validation Solutions

Process validation is crucial part in the product development.  The U.S. Food and Drug Administration (FDA) has proposed guidelines that defines process validation as establishing documented evidence which provides a high degree of assurance that a specific process (such as the manufacture of pharmaceutical dosage forms) will consistently produce a product meeting its predetermined specifications and quality characteristics.

​Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished products (pharmaceuticals: 21CFR 211 and medical devices: 21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices. In section 820.75 the FDA goes on to say:

  • (a)    “Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.”
  • (b)      Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

Similarly, ISO 13485:2016 says, “The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement

Process validation involves a series of activities taking place over the lifecycle of the product and process, which can be described in three stages:

  • Stage 1 – Process Design: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.
  • Stage 2 – Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.
  • Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Process validation includes 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.

STS Process Validation Solution team of experts will guide and support through all the stages of development to attain the validated process status. Our team will help you put together the master plan and guide you through the validation protocols, which will provide the map of the processes to be validated and all the related resources that needs to be validated. Based on the final product type, we can develop a customized Process Validation Solution to avoid risks and challenges in manufacturing a quality product.  ​