How long must batch records be kept?

1Minimum retention periods at a glance.

The period depends on the product, the jurisdiction and, for investigational products, the clinical trial. These are the minimums the rules set.

2What 21 CFR 211.180 requires.

Section 211.180(a) applies to “any production, control, or distribution record” that Part 211 requires and that “is specifically associated with a batch of a drug product”. It must be kept for at least one year after the batch’s expiry date or, for certain OTC products exempt from expiry dating under 211.137, three years after the batch is distributed. Section 211.180(b) sets the same periods for records of components, containers, closures and labelling; for those OTC products, the three years run from distribution of the last lot that used them.¹

The rest of the section governs how records are kept. Under 211.180(c), records must be “readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred”; records that can be immediately retrieved from another location electronically meet that requirement. Under 211.180(d), records may be kept as originals or as true copies, such as photocopies or microfilm. Section 211.180(e) requires records to be kept so their data can be used to evaluate each product’s quality standards at least annually.¹

Other US rules set their own periods for some products. Licensed biologics keep records long enough to permit the return of clinical reports of unfavourable reactions, and for at least five years after the records of manufacture are completed or six months after the latest expiry date, whichever is later.² Establishments handling human cells, tissues and cellular and tissue-based products keep records for 10 years after creation, and records for a particular product for at least 10 years after its administration, or after its distribution, disposition or expiry, whichever is latest, if the administration date is not known.³ For investigational drugs, the IND sponsor keeps its records of the drug’s receipt, shipment and disposition, including the batch or code mark of each shipment, for two years after a marketing application is approved or, if none is approved, until two years after investigational shipment stops and FDA has been notified.⁴

3What EU law requires.

For human medicines, Article 9 of Commission Directive (EU) 2017/1572, which repealed Directive 2003/94/EC, requires a documentation system that will “enable the history of the manufacture of each batch to be traced”, and requires the manufacturer to retain the batch documentation “for at least 1 year after the expiry date of the batches to which it relates or at least 5 years after the certification” by the Qualified Person, “whichever is the longer period”.⁵

For investigational medicinal products, Article 8(3) of Delegated Regulation (EU) 2017/1569 requires the manufacturer to retain the product specification file and batch documentation “for at least five years after the completion or discontinuation of the last clinical trial in which the batch was used”.⁶

Chapter 4 of the EU GMP guide, in operation since 30 June 2011, repeats both periods in section 4.11 and goes further for other records. Critical documentation, including raw data that supports the marketing authorisation, should be kept while the authorisation is in force. Raw data superseded by a full new data set may be retired with a documented justification, but process validation raw data should be kept at least as long as the records of every batch released on the basis of that validation.⁷

4How the APIs rule works with retest dates.

ICH Q7 asks for production, control and distribution records to be kept for at least one year after the batch’s expiry date, and, for APIs with retest dates, “for at least 3 years after the batch is completely distributed”. During that time, originals or copies should be readily available where the activities took place, and records may be kept as originals or as true copies, such as photocopies or microfilm.⁸

The ICH Q7 questions and answers of June 2015 explain “completely distributed” as distribution of the entire batch by the API manufacturer to the next party in the supply chain, or of the received quantity for agents, brokers and distributors. They say the intent is to keep records for as long as the API could be on the market, that “at least three years” covers longer periods, and that companies should consider keeping records for as long as drug products made with the API may be on the market.⁹

5Cell and gene therapies keep traceability data longer.

The EU GMP guidelines for advanced therapy medicinal products apply the same batch documentation periods, with five years after the last clinical trial for investigational products. Their traceability data, which link each donation to the batch and the recipient, are kept “for a minimum of 30 years after the expiry date of the product”, unless the marketing authorisation sets a longer period.¹⁰

6Keeping records usable for the whole period.

A retention period is only met if the record can still be read and trusted at the end of it. Part 11 requires closed systems to protect electronic records “to enable their accurate and ready retrieval throughout the records retention period”, and to keep audit trails for at least as long as the records they cover.¹¹ In the EU, a manufacturer that keeps documentation electronically must first validate the system to show the data will be stored appropriately for the anticipated period, protect the data by duplication or back-up, and maintain audit trails.⁵ Chapter 4 asks for it to be clearly defined which record relates to each activity and where it is kept, with secure controls on integrity throughout the retention period.⁷

7How it runs in Seal.

In Seal, an electronic batch record records the form version it ran on and becomes a signed, searchable record of what actually happened, and its audit history preserves original and changed values, reasons, users and times. Procedures behind the batch keep one effective version with every earlier version and its approvals retained, as document control describes.

For records that already exist on paper, Neil reads scanned paper records into values, each linked to the place on the page it came from, and the scan stays with them. Whether a scan stands in for the paper original is your quality unit’s decision under your retention procedure.