• Medical Devices

  Overview and The 3 Stages of Process Validation

  Posted by Mark Anderson on October 25, 2022 at 4:37 am

  Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs.

  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 finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification.

  What is the guidance for process validation?

  This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.

  The 3 Stages Of Process Validation

  The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

  Stage 1 – Process Design

  This is the research and development phase and involves defining a process for manufacturing the product. It usually includes the following:

  • Creation of a Quality Target Product Profile (QTPP)

  • Identifying Critical Quality Attributes (CQAs)

  • Defining Critical Process Parameters (CPPs)

  • Conducting risk assessments

  From a regulatory point of view, an essential component of this stage is meticulous and comprehensive record keeping.

  That said, the collection and evaluation of data as part of this Process Validation stage also has business benefits too. This is because you can use the data to optimise your production process, create efficiencies, and troubleshoot problems.

  Stage 2 – Process Validation or Process Qualification

  This stage evaluates/qualifies the process designed earlier to ensure it can reproduce consistent and reliable levels of quality.

  It involves collecting and evaluating data on all aspects and stages of the manufacturing process. This includes:

  • The building and facilities, i.e. ensuring they adhere to local regulations as well as pharmaceutical manufacturing regulations

  • The transportation of raw materials

  • Storage of raw materials

  • The knowledge, training, and working practices of production line employees

  • Every step of the process to turn raw materials into the finished product. This includes having pre-defined sampling points at various stages of the process.

  • Finished product packaging, storage, and distribution

  Another useful component of this stage of Process Validation is to develop contingency plans for situations where things go wrong.

  Stage 3 – Continued Process Verification

  Continued Process Verification involves ongoing validation during production of the commercial product to ensure the process designed and qualified in the previous stages continues to deliver consistent quality.

  One of the main aims of this stage is to detect and resolve process drift.

  The stage involves product sampling, analysis, and verification at various points in the manufacturing process, and requires the involvement of employees with quality control training.

  Mark Anderson replied 2 years ago 1 Member · 0 Replies
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