Quality control in pharmaceutical Industry

2. 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.

3.  Independence of QC from production is considered
fundamental.
 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
out.

4. 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
GMP purpose.

5. Quality Control
QC labs
Sampling
Validation
Records
Analysis of
Finished
Product
Retained
Samples
Batch
Inspection and
Sampling

6. QC LABS
QC Labs
3.Microbioloy
and
Toxicology lab
6. Relevant
Books
8. Trained
Personnel
1. Chemical
Testing Lab
5.
Documentation
Room
4. Provision
for retained
samples and
stability
samples
2. Instrumental
Analysis Lab
7. SOPs

7. SAMPLING
Sampling
Sops for
RM/FM/IM
Approved
method for
sampling
Well trained
personnel
and sampling
tools
Records
maintenance
of all
sampling
Checklist for
every stage
Sops divided
into – before,
during and
after

8.  All the methods used by QC, say for
sampling, testing and other activities must be
validated.
 Validation of testing method is particularly
very important.
VALIDATION

9.  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
investigated.
 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)
RECORDS

10.  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.
FINISHED PRODUCT

11. Batch inspection and relevant sampling

12.  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
large.
RETAINED SAMPLES

13. 1. Establish, validate and
implement all the quality control
procedures, maintain sufficient
standards and reagents
4. Assess production
conditions and IPQAC
results.
7. Assess the finished
product after evaluation.
2. Evaluate, maintain and store
references and working standards
for substances.
5. Participate in the
investigation of
complaints related to
quality of the product.
8. Assess manufacturing
and packaging
documentation.
3. Ensure the correct labeling of
containers, materials and
products.
6. Participate in the
environment monitoring.
9. Compliance with
specification of the
finished product and
examination of final pack.
OTHER ACTIVITES OF QC