Expiry Period for Reagents Used in the Laboratories | FDA

How does FDA interpret the regulations (21CFR part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents?

 

Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 21 CFR 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (#buffers, acids/bases, quantitative analytical preparations, etc.), whether purchased or prepared in-house. 

 

Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products.

 

If the purchased laboratory reagent or solution includes a manufacturer’s suggested use-by or expiry date, that date should be followed.

 

For purchased laboratory reagents and solutions without a “use by” or expiry date, FDA would expect that an assessment be conducted (a literature review may be acceptable) of that specific chemical’s or chemical family’s stability and that an appropriate use-by or expiry date be determined.

 

For in-house prepared solutions, such as mobile phases or other nonquantitative solutions, FDA would expect that an assessment be conducted (again, literature review may be acceptable) to determine an appropriate expiry period. 

 

However, for in-house prepared solutions used for quantitative analysis, such as sample or standard solutions used in assay or impurity testing or titration solutions, FDA requires that formal stability studies be conducted to determine an appropriate expiry. 

 

As mentioned in the ICH guidance for industry the stability of analytical solutions is a typical method variation that should be evaluated during robustness testing during method validation. 

 

Method validation is a CGMP requirement at 21 CFR 211.160(b).

 

The determined use-by or expiry dates should be documented within a procedure and followed. 

Procedures for any in-house prepared laboratory solution should include the determined stability timeframe and should instruct that these solutions be labeled with the appropriately determined use-by or expiry date upon preparation and discarded upon expiration.

 

These principles would also apply to active pharmaceutical ingredient (API) manufacturing and testing sites. 

 

The use of “reagents and solutions” and use-by dates are found throughout the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

 

References:

• CFR 211.160: General requirements
• CFR 211.194: Laboratory records
• ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 11, Laboratory Controls
• ICH Q2(R2) guideline on validation of analytical procedures

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Resource Person: BARBARA PIROLA