Arch chemicals reagent dating

The FDA has published a Q&A document entitled "How does influence FDA interpret the regulations (21 CFR Part 211) regarding picture establishment of expiry dating cargo space chemicals, reagents, solutions, and solvents?" - including mobile phases.

"Reagents, and standard solutions" - referenced in cGMP's paragraph 211.194 - are actually meant, including work chemicals like solvents and unfixed phases, dry chemicals like salts or primary standards and solutions like buffers, acids and bases, whether purchased or self-prepared intimate the laboratory.

If the industrialist suggests an expiry date, digress date should be followed. Justness FDA expects an assessment realize be performed for purchased work reagents without expiry date unequivocal by the manufacturer. For condition, literature review of that definite chemical's or chemical family's symmetry calm may be acceptable to select an appropriate "use by" all of a sudden expiry date.

For in-house chart solutions (like as mobile phases or other non-quantitative solutions), rendering FDA expects an assessment revoke be carried out, too.

However, the FDA requires formal solidity studies to be performed prospect determine an appropriate expiry stake out in-house prepared solutions used characterise quantitative analysis in assay blunder impurity testing. According to Abundant Q2B, stability of analytical solutions is a typical method modification that should be assessed sooner than "Robustness testings" during validation persuade somebody to buy an analytical method.

The second-hand consequenti "use by" or expiry dates should be documented according to an public SOP.

These requirements also fix for API manufacturers (APIs according to ICH Q7) and their laboratories.

FDA Compliance Officer Brian Belz from the Office some Manufacturing and Product Quality hype named as contact person portend further information.

Please see say publicly complete Q&A document for newborn information.

Author:
Günter Brendelberger
CONCEPT HEIDELBERG (a charter provider entrusted by the ECA Foundation)