Page 13 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

One critical requirement of all drug manufacturers is that products can only be
released to the marketplace if they meet all QC specifications, and they have
been manufactured in accordance with the details approved by the government
regulatory agency, and there have been no unresolved manufacturing errors.
The batch record provides the evidence and the assurance that the product is
safe to release. The QA Department is required to independently oversee and

review these activities.

What do the GMP rules say?

US FDA CFR 211

Sec 211.22 Responsibilities of quality control unit.

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.

** Note: The term "Quality Control Unit" may be interpreted to mean a suitable
combination of Quality Assurance and Quality Control.

FDA Guidance for Industry Quality Systems Approach to Pharmaceutical
CGMP Regulations

This guidance uses the term quality unit (QU) to reflect modem practice while
remaining consistent with the CGMP definition in§ 210.3(b)(15). The concept of

a quality unit is also consistent with modern quality systems in ensuring that
the various operations associated with all systems are appropriately planned,
approved, conducted, and monitored.

International GMPs

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