Quality control unit, responsibility

Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control. 

Responsibilities of quality control unit. 211.25 Personnel qualifications. 

Subpart B, Organization and Personnel 211.22 Responsibilities of the quality control unit 211.25 Personnel qualifications 211.113 Control of microbiological contamination Subpart F, Production and Process Controls Subpart I, Laboratory Controls 211.167 Special testing... 

Violations of 21 CFR 122d (failure to create adequate, written responsibilities and procedures for the quality control unit or failure to follow them), occurring in 42% of the 483 s... 

Subchapters 2.6 and 2.7 deal with the responsibilities of the head of the quality control unit (quality control department) and 6.2 with the responsibihties of the quality control unit as a whole. Requirements for resources are covered in Subchapter 6.1. Correspondences to regulation 211.25 are covered in Subchapters... 

The cGMP regulations assign specific duties to the quality control unit. The unit is required to have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material,... 

B Organization and personnel Responsibilities of the quality control unit... 

CFR211.22(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 [1],... 

The API Assay, the Assay of Impurities and Product Stability. The central independent analytical research and quality control unit is responsible for the analytical release of both the API and the formulated drug product for the drug development programs. The central independent QC unit provides all the analytical data needed to build the analytical specification for the IND. It is recognized by those involved that the IND is a relatively raw document compared with the later NDA, which is built on data from a more developed process situation, using more refined analytical techniques. 

Eailure to have a Quality Control Unit adequate to perform its functions and responsibilities, as required by 21 CFR 211.22, as demonstrated by the number and type of inspectional observations. [FDA Warning Letter, 2002]... 

CFR 211.22 is the regulation that sets forth the responsibilities of the Quality Control Unit (QCU). There is no difference in the required roles and responsibilities of the QCU in the manufacture of clinical supplies vs. commercial products. The FDA considers the presence of an adequately staffed and trained QCU, empowered with authority to carry out its responsibility effectively, as a critical factor in GMP compliance. 

This section makes it clear that the quality control unit is not the only group responsible for the quality... 

Sections of the cGMPs most pertinent to the pharmaceutical microbiologist include Subpart B Organization and Personnel 211.22 Responsibilities of the Quality Control Unit and 211.25 Personnel... 

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