Record Retention
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.
The requirement to retain GxP records — batch records, raw data, validation documentation, complaint and training files — for a defined minimum period after batch release, product expiry, or study completion, ensuring records remain retrievable for inspection, investigation, or reconstruction of a product’s history.
Retention periods differ by record type and jurisdiction: FDA cGMP regulations tie drug batch-record retention to at least one year after the batch expiration date, while records supporting a biologics license or an approved application may need to be kept for the life of the application. Clinical trial records have their own, often longer, retention requirements tied to marketing authorization status.
Record retention is a distinct requirement from record retrieval: a retained record that cannot be located and produced within a reasonable inspection timeframe is, in practical inspection terms, treated no differently from a missing one. Retention policies therefore specify not just duration but storage location, format, and indexing.
For electronic records, retention intersects with backup-and-archive and disaster-recovery practices — a record retained only in a backup that is never tested for restorability does not satisfy the intent of the requirement.
- —Retention periods vary by record type and regulatory jurisdiction
- —Tied to batch expiration, application life, or study/trial status depending on record type
- —Retrievability within a reasonable timeframe matters as much as retention duration
- —For electronic records, depends on tested backup and archive practices
21 CFR 211.180(a)-(c); EU GMP Part I Chapter 4 (Documentation)
Frequently asked questions
What is Record Retention?
The requirement to retain GxP records — batch records, raw data, validation documentation, complaint and training files — for a defined minimum period after batch release, product expiry, or study completion, ensuring records remain retrievable for inspection, investigation, or reconstruction of a product’s history.
Which regulations cover Record Retention?
21 CFR 211.180(a)-(c); EU GMP Part I Chapter 4 (Documentation)