21 CFR 211.167 - Special Testing Requirements

Overview:

21 CFR 211.167 sets special testing requirements for drug products, including sterility, pyrogen-free status, ophthalmic ointment quality, and controlled-release dosage forms. 

The regulation mandates written test procedures to ensure conformance with specifications for each batch. It primarily serves pharmaceutical manufacturers and quality control teams to ensure drug products meet safety and performance standards.

(a) 

For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.

(b) 

For each batch of ophthalmic ointment, there shall be appropriate testing to determine conformance to specifications regarding the presence of foreign particles and harsh or abrasive substances. The test procedures shall be in writing and shall be followed.

(c) 

For each batch of controlled-release dosage form, there shall be appropriate laboratory testing to determine conformance to the specifications for the rate of release of each active ingredient. The test procedures shall be in writing and shall be followed.