Concurrent Validation
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A validation approach in which product manufactured during the qualification runs is released for distribution based on real-time monitoring and testing of each individual batch against predefined acceptance criteria, used only in defined circumstances — such as limited supply or an orphan product — with documented quality-unit justification and heightened in-process control.
Concurrent validation exists for situations where waiting for a full prospective validation campaign to complete before releasing any product is not practical or is clinically inappropriate — a drug shortage, or a very small production volume such as an orphan drug. It is not a default option: it requires a documented, quality-unit-approved rationale explaining why prospective validation was not used.
Because release decisions are being made batch by batch while the validation exercise is still underway, each individual batch must independently meet every specification on its own merits — a batch cannot ride on the strength of the batches around it, and monitoring is typically more intensive than for routine production.
- —Product is released from qualification runs based on real-time, batch-by-batch results
- —Requires prior, documented quality-unit approval and justification — not a default approach
- —Common justifications: drug shortage, orphan/small-volume product
- —Each released batch must independently meet all specifications
- —Monitoring and in-process control are heightened relative to routine production
FDA Process Validation: General Principles and Practices (2011); EU GMP Annex 15
Frequently asked questions
What is Concurrent Validation?
A validation approach in which product manufactured during the qualification runs is released for distribution based on real-time monitoring and testing of each individual batch against predefined acceptance criteria, used only in defined circumstances — such as limited supply or an orphan product — with documented quality-unit justification and heightened in-process control.
Which regulations cover Concurrent Validation?
FDA Process Validation: General Principles and Practices (2011); EU GMP Annex 15