Good

practices in
quality
control
What is quality control
• Quality control (QC) is a procedure or set of procedures intended to ensure that a
manufactured product or performed service adheres to a defined set of quality
criteria or meets the requirements of the client or customer.
• QC is the part of GMP concerned with sampling, specifications and testing and
documentation which ensure that the necessary and relevant tests are actually
carried out and that materials are not released for use, nor products released for
sale or supply, until their quality has been judged to be compliant with the
requirements.
• All testing should be performed as per written and approved procedure. This can
be a monograph or a product specification. Results should be checked by the QC
manager/ designate before material or product is released or rejected

QC SHOULD BE INDEPENDENT FROM PRODUCTION

DEFINITION OF TERMS
• Expiry date-The date given on the individual container (usually on the label) of a product up to
and including which the API and FPP are expected to remain within specifications, if stored
correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
• Re-test date-The date after which an API/Excipient should be re-examined to ensure that the
material is still in compliance with the specification and thus is still suitable for use in the
manufacture of an FPP
• Shelf-Life-The period of time during which an API or FPP, if stored correctly, is expected to comply
with the specification as determined by stability studies on a number of batches of the API or FPP.
The shelf-life is used to establish the expiry date of each batch.
• Sample-A portion of a material collected according to a defined sampling procedure.
• Composite sample-sample resulting from combining all or parts of two or more samples of the
same batch of material
• Retention sample- samples collected as part of the original sampling process and reserved for
future testing
• In-process sample-product sample that has gone through all manufacturing steps, awaiting
testing and packaging. This proves that we are on track and gives a provision for corrective action
Basic requirements of QUALITY CONTROL
1. Adequate facilities, trained personnel and approved procedures must be available for
sampling, inspecting, and testing starting materials, packaging materials, and intermediate,
bulk, and finished products, and where appropriate for monitoring environmental conditions
for GMP purposes
2. Samples of starting materials, packaging materials, intermediate products, bulk products and
finished products must be taken by methods and personnel approved by the QC department;
3. Records must be made demonstrating that all the required sampling, inspecting and testing
procedures have actually been carried out and that any deviations have been fully recorded
and investigated( Good documentation practices)
4. The finished products must contain ingredients complying with the qualitative and quantitative
composition of the product described in the marketing authorization; the ingredients must be
of the required purity, in their proper container and correctly labelled
5. Records must be made of the results of inspecting and testing the materials and intermediate,
bulk and finished products against specifications; product assessment must include a review
and evaluation of the relevant production documentation and an assessment of deviations
from specified procedures
6. Sufficient samples of starting materials and products must be retained to permit future
examination of the product if necessary; the retained product must be kept for the appropriate
time in its final pack unless the pack is exceptionally large, in which case one that is equivalent
to the marketed packaging system may be used
7. Raw materials can only be sourced from approved suppliers as per the prescribed procedure
 Sampling
RAW MATERIALS
On receipt of the Goods Received Voucher(GRV) the analyst or designate logs it into the raw material
GRV log book. Original copies of manufactures CoA and MSDS should also be submitted to the
laboratory. CoA contains the following,
• ID of supplier
• Name of material tested
• Batch number
• Specification and methods used for testing
• Results obtained
The sampler then:
o Uses the CoA to verify that material has been sourced from Approved manufacturer
o Verify that the expiry date or retest date or best before date is at least 4/5 of the supplied materials
shelf life
o Fill in the sampling sticker(orange and white) with the aid of the GRV
Sample tracking number on the composite sample should be the same as the one on the retention
sample sticker
Information form the MSDS, CoA and Pharmacopeia must be used to highlight precautions that need
to be employed when handling the materials both in the laboratory and in production
RAW MATERIALS continued………………..
Samples should be a representative of the bulk from which they are taken from.
Sampling equipment should be cleaned and sterilized before used and stored
separately. Care should be taken during sampling to avoid cross contamination
Samples that require microbiological test must be sampled by the microbiologist
before sampling for chemical testing
Sample size/ amount should be an amount adequate to permit at least three full
examinations. For solid samples composite samples is 20g, 40g for retention
samples
Containers that have been sampled should be marked accordingly and carefully
resealed after sampling
Sampling is done in the sampling booth, warehouse(paste,waxes,fats and grease),
dangerous drug room( Codeine, Pseudoephedrine,Meprobamate and
Phenylephrine),Alcohol store for flammable liquids
Sampling should be done as per SOP 100.01-Raw material sampling
RAW MATERIALS………………continued
• TESTING
All raw materials should be tested for conformity with specifications for
identity, strength, purity etc
Identity test is carried out on a sample from each container of the same
lot number.
All raw materials are received with a certificate of analysis from the
manufacture/supplier.
Results on the CoA are often compared to our own results to assess the
reliability of our suppliers
Storage of raw material samples
Samples are generally stored in locked in sampling baskets. Storage
conditions are stated by the manufacturer’s MSDS
All retention starting material are boxed sequentially using the
Laboratory reference numbers
Dangerous drugs retention samples are taken back to the dangerous
drugs room
Storage of samples during testing is also important so that the integrity
of the raw material is maintained
In process/intermediate products
For each batch of medicines, there should be an appropriate laboratory determination of
satisfactory conformity to its finished product specification prior to release
Finished products are tested as per approved product specification. Test
include physical tests, chemical test and microbiological tests
In-process control limits should always be tighter than QC limits and QC
limits tighter than stability limits
Analytical methods for testing should be validated
Products failing to meet specifications should be rejected
Out-of-specification results obtained during testing of materials or products
should be investigated in accordance with an approved procedure.
Results are trended for OOT, and any result falling outside the control limits
has an OOT report generated.
Product testing and results are recorded in an analytical workbook and
datasheet which will be filed together with the batch manufacturing records
Batch record review
QC records should be reviewed as part of the approval process of batch release
before transfer to the authorized person. Any divergence or failure of a batch to
meet its specifications should be thoroughly investigated. The investigation should,
if necessary, extend to other batches of the same product and other products that
may have been associated with the specific failure or discrepancy. A written record
of the investigation should be made and should include the conclusion and follow-
up action.
Retention samples from each batch of finished product should be kept for at least
one year after the expiry date. Finished products should usually be kept in their
final packaging and stored under the recommended conditions. If exceptionally
large packages are produced, smaller samples might be stored in appropriate
containers. Samples of active starting materials should be retained for at least one
year beyond the expiry date of the corresponding finished product. Other starting
materials (other than solvents, gases and water) should be retained for a minimum
of two years if their stability allows. Retention samples of materials and products
should be of a size sufficient to permit at least two full examinations.
Good Quality Control Practices
• Recording data in real time
• Any changes or adjustments from approved documents should be recorded
as deviations. Everything has to be approved by QA before
implementation/closure
• Qualification and calibration of equipment, appropriate glassware etc.
• Freshly prepared volumetric solutions, mobile phases and samples –if not
provide stability data
• Qualified working standards
• Current versions of documents and pharmacopeia's
• Having qualified personnel with appropriate scientific
background/experience
• Adequate working space
REFERENCES
• WHO Good Practices for Pharmaceutical Quality Control Laboratories.
WHO Expert Committee on Specifications for Pharmaceutical
Preparations. Forty-fourth Report. Geneva, World Health
Organization, 2010 (WHO Technical Report Series, No. 957, Annex 1.
• WHO good manufacturing practices for pharmaceutical products:
main principles, TRS No 986 Annex 2