Up to now, the terms Quality Control, Quality Control Unit, Quality Unit
were not exactly defined in FDA's rules and regulations. Clear statements
regarding independence or analogies were missing. For example it was not
obvious who is responsible for the quality system, controls and release.
The Guidance for Industry: Quality Systems Approach to Pharmaceutical
cGMP Regulation does now try to define these terms more precisely. The
document defines the Quality Unit as the concept which "is also consistent
with modern quality systems in ensuring that the various operations
associated with all systems are appropriately planned, approved, conducted
and monitored".
Assigned responsibilities are for example:
- Ensuring that controls are implemented and completed satisfactorily
during manufacturing operations
- Ensuring that developed procedures and specifications are
appropriate and followed
- Approving and rejecting incoming materials, in-process materials and
drug products
- Reviewing production records and investigating any unexplained
discrepancies
Responsibilities are divided between quality control (QC) and quality
assurance functions (QA). The QC usually assesses suitability of
components and products, evaluates the performance of the manufacturing
process with respect to specifications and limits and determines the
acceptability of each batch for release, The QA reviews and approves
procedures, reviews records and performs audits and trend analyses.
Nevertheless, the FDA does not move away from the term Quality
Control Unit (QCU), which is defined in CFR §210.3(b)(15) and
described in §211.22. This still leaves a bit of ambiguity. According to
CFR §210.3, the Quality Control Unit is responsible for the duties
relating to quality control, whereas according to §211.22, the QCU has the
responsibility to approve or reject.
The Guidance was published 29 September 2006 (see
news from 05 October 2006) and contributes
to the goals of the FDA's "cGMPs for the 21st Century" and "Critical Path
Initiative" (www.fda.gov/oc/initiatives/criticalpath/)
which seek to modernise the development of new drugs.
The full text of the guidance can be found at:
http://www.fda.gov/cber/gdlns/qualsystem.pdf
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