21 CFR 211.22 - Responsibilities of Quality Control Unit

Overview:

21 CFR 211.22 outlines the responsibilities of the quality control unit in pharmaceutical manufacturing. It grants the unit the authority to approve or reject components, packaging materials, in-process materials, and finished drug products, including those produced under contract. 

The regulation requires adequate laboratory facilities for testing and mandates that all procedures affecting drug identity, strength, quality, and purity be documented and strictly followed. This regulation ensures compliance with quality standards to maintain the integrity and safety of drug products.

(a) 

There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) 

Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.

(c) 

The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

(d) 

The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.