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Welcome

Quality Assurance

- - -
o Buildings and Facilities Office
o Manufacturing
o Packaging and Labeling
o Product Development Laboratory
o QC - Analytical Labs
o QC - Batch Release
o Quality Assurance
o Receiving and Shipping
o Regulatory Affairs
o Training Department
o Validation Department

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Caption below

Quality Auditor in Production Area

QA functions as the company's internal quality auditing and compliance group. Generally, they are most interested in more global issues and less interested in the day-to-day testing and release of specific products (QC does that). They ensure that the company understands and is adhering to GMP requirements. They frequently conduct periodic GMP training to personnel at all levels of the organization. They also are the liaison with the local FDA office.

QA also is an arbitrator between the QC functions and production departments. According to GMP, the "Quality Control Unit" (which includes QC and QA) must make the final decisions related to product quality and GMP compliance.

Example of a GMP expectation that applies to Quality Assurance

There is a formally defined quality unit (Quality Assurance and/or Quality Control) which has the autonomy and authority to act independently.

Example of GMP requirements specific to this GMP expectation

U.S. flag  U.S.

  • 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. [211.22(a)]

Canadian flag  Canada

  • Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall have on his premises in Canada a quality control department that is supervised by personnel described in section C.02.006. [C.02.013(1)]

  • The quality control department referred to in subsection (1) shall be a distinct organizational unit that functions and reports to management independently of any other functional units including the manufacturing, processing, packaging or sales unit. [C.02.013(2)]

European Union flag  European Union

  • Each holder of a manufacturing authorization should have a Quality Control Department. This department should be independent from other departments, and under the authority of a person with appropriate qualifications and experience, who has one or several laboratories at his disposal. Adequate resources must be available to ensure that all the Quality Control arrangements are effectively and reliably carried out. [EU # 6.1]

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