How does the FDA interpret the regulations 21 CFR Part regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? Answer :.
This Standard Operating Procedure (SOP) is applicable to the chemicals, reagents and solutions used in analytical testing designed to define and standardise labelling and handling procedures in laboratories. The appropriate handling of chemicals, reagents and solutions and the process of assigning them a reasonable shelf life are key procedures in the quality laboratory that ensure the. 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. reagents, and record these on each container at the time of receipt (reagents) or preparation (solutions). 5 Guideline Purchased Reagents On receipt of purchased reagents the date should be recorded on each container so that it's approximate age is subsequently known. An expiry date as well as the opening date must be added when the File Size: 76KB.
Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products. For purchased laboratory reagents and solutions without a "use by" or expiry date, FDA would expect that an assessment be conducted 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.
Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply.
In these instances, the use of computer systems in the generation of paper records would not trigger part Persons must comply with applicable predicate rules, and records that are required to be maintained or submitted must remain secure and reliable in accordance with the predicate rules.
For high performance liquid chromatography HPLC and gas chromatography GC systems and other computerized systems involving user inputs, outputs, audit trials, etc.
Section The chromatogram does not generally include, for example, the injection sequence, instrument method, integration method, or the audit trail, of which all were used to create the chromatogram or are associated with its validity. Therefore, the printed chromatograms used in drug manufacturing and testing do not satisfy the predicate rule requirements in part The electronic records created by the computerized laboratory systems must be maintained under these requirements.
We recognize that there are cases where it could be appropriate for the printed chromatogram to be used within laboratories for the review of test results. Similarly, it also may be acceptable to provide the printed chromatogram during a regulatory inspection or for application review purposes.
How can a laboratory establish the expiration dating of chemical solutions and reagents not provided by sup- pliers, or for chemical solutions prepared in-house? Sep 19, Sec. Reagents and solutions. All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used. Jun 28, Take for example, reagents. ANP on the CAP checklist requires that "All reagents are used within their indicated expiration dates." If there is not a manufacturer provided expiration date, it is up to your laboratory to assign one.
In summary, decisions on how to maintain records for computerized systems should be based on predicate rule requirements. It may be okay to eat bread a few days past its expiration date, but the materials we use in our labs have expiration dates too, and this is something that CAP checks on.
Take for example, reagents. In order to be CAP compliant, your lab must have a written policy for evaluating reagents that are lacking an expiration date. This assessment must also be documented, and a system put in place for regular, yearly, reassessment.
"Reagents, and standard solutions" - referenced in cGMP's paragraph - are actually meant, including laboratory chemicals like solvents and mobile phases, dry chemicals like salts or primary standards and solutions like buffers, acids and bases, whether purchased or self-prepared in the laboratory. Laboratory "reagents, and standard solutions," as referenced in the CGMP regulations at 21 CFR , includes laboratory chemicals such as solvents (including mobile phases), dry chemicals. For purchased laboratory reagents and solutions without a "use by" or expiry date, FDA would expect that an assessment be conducted (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.
A label on the reagent should be applied, indicating the date it should be re-verified through technical assessment.