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Qc is the part of GMP concerned with sampling,
specifications and testing and with the organization,
documentation and release procedures which ensure that the
necessary and relevant tests are actually carried out and the
materials are neither released for use, nor products are used for
sale & supply until their quality has been satisfactory.
Independence of QC from production is considered
QC head should have appropriate qualification and
experience, which has control over one or several labs.
Adequate resources must be available to ensure all quality
control arrangements are effectively and reliably carried
Adequate facilities, trained personnel and approved
procedures must be available for sampling, inspecting
and testing of starting materials, packaging materials
and intermediate bulk and finished products and where
appropriate of monitoring environmental conditions for
into – before,
All the methods used by QC, say for
sampling, testing and other activities must be
Validation of testing method is particularly
Records must be made (manually and/or by recording instrument)
demonstrating that all the required sampling, inspecting, testing procedures
have been actually carried out and that any deviation have been recorded and
Recording is the primary basis of any pharmaceutical activity and hence all
regulations insist on recording of each and every activity carried out. This
helps in tracing the history of a batch produced; this may be required in future
if any investigation is to be made.
The basic concept of GMP is – Do as you have written (i.e. SOPs) and write
what you have done ( i.e. RECORDS)
The finished product must contain ingredients
complying with qualitative and quantitative
composition of the product described in the marketing
authorization, the ingredients must be of required
purity, in their proper containers and correctly labeled.
Sufficient samples of starting materials and products
should be retained to permit further examination of
the product if necessary; the retained samples must be
kept in the final pack unless the pack is exceptionally
1. Establish, validate and
implement all the quality control
procedures, maintain sufficient
standards and reagents
4. Assess production
conditions and IPQAC
7. Assess the finished
product after evaluation.
2. Evaluate, maintain and store
references and working standards
5. Participate in the
complaints related to
quality of the product.
8. Assess manufacturing
3. Ensure the correct labeling of
containers, materials and
6. Participate in the
9. Compliance with
specification of the
finished product and
examination of final pack.
OTHER ACTIVITES OF QC