The requirement for Validation in the Pharmaceutical & Medical Device industries.

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Process validation is an essential element of the compliant design, development, manufacture and release to market. It is essential not only for the quality, safety and efficacy of the product itself, but also for a manufacturer to be able to demonstrate to regulatory bodies that a product in indeed “fit for purpose”. Pharmaceutical Validation (Medical Device & Biotech) needs to be risk based so that the validation efforts are appropriately focused, the validations must be performed by competent staff, and need to apply to expected and worst case conditions. The validation process must be planned out in advance, must be comprehensively documented and records need to be stored in a manner such that relatively easy retrieval can be achieved over the long term. Consideration needs to be given to the necessity for on-going revalidation, also the change management and control processes must include checks to confirm prior validations are not compromised by any proposed change, or where prior validation could be impacted, then consideration must be given to performing re-validation as part of the change approval process.

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Many organizations apply a life cycle approach to validation. This is a continuous approach to validation, where the process commences with the identification of the functional and system requirements, progresses onto validation performance, then feeds-back in a continuous loop of revalidation, re-verification, risk re-rating, etc.,  to ensure on-going validation compliance with regulatory expectations and business validation policies and strategies.

There needs to be an effective quality system in place. For many medical device companies, this means compliance with ISO 13485. There needs to be defined, documented and effective implementation of process and design controls, a documentation management system must be in-place, effective test and inspection processes, corrective action processes, an internal audit program, an effective customer feedback and complaints process, etc.,etc.

Pharmaceutical validation (Medical Device & Biotech) needs to be risk based. From a regulatory perspective the risk is primarily focused on patient and user health and safety. However, from an organizational perspective risk needs to consider the whole organization. Litigation is a major risk to a business and inadequate product or process validation can significantly contribute to increased risk of litigation. Inversely, comprehensive validation can be a strong defense to future litigation risks. Risk assessment, risk management and risk control all need to drive the validation efforts and are one of the first considerations in a process validation program.

Planning the validation process is essential to successful regulatory compliance and critical in terms of output quality and reliability. A validation master plan is the standard approach to ensuring good planning practice. The VMP details a path to be taken from initial risk determination, through to protocol development and approval. The VMP details the critical processes, details the reason for performing a validation and reasons where “not to be validated” decisions  are taken. The VMP details the process for protocol revision and re-approval, the approach to re-validation, etc..

Reference sources:

FDA – Process Validation. General principles and practices

European Medicines Agency – Process Validation for finished products