Quality Control
S.M. Shamsuzzaman
GM, Quality Control
In the pharmaceutical industry, quality control is crucial for maintaining patient safety, adhering to
legal requirements, and safeguarding the company's brand. Only the best products are made
available for purchase after testing the raw ingredients, products under production, and final
products.
Quality Control facilities
Radiant Pharmaceuticals Limited is the owner of a fully functional quality control laboratory that is
housed in a building apart from the production site. The laboratory includes well-equipped physical,
chemical, and microbiological labs. A group of individuals with years of experience in
pharmaceutical product analysis, strong work ethics, a commitment to data integrity in product and
material analysis, and qualifications in chemistry, biology, pharmacy, and microbiology, among
other fields, carry out sample analysis and environmental monitoring.
Objectives of Quality Control in the Pharmaceutical Industry
1. Ensure Patient Safety:
The safety of the patients comes first. All medications must adhere to strict safety
requirements prior to approval, and quality control is essential in making sure that these
requirements are fulfilled.
2. Compliance with Regulations:
Worldwide, the pharmaceutical business is subject to strict regulations. To guarantee
adherence to laws in both the country of manufacture and the countries in which the
medications will be sold, quality control is crucial.
3. Protect Company Reputation:
In the pharmaceutical industry, the public's trust is crucial. A company's reputation can be
damaged by a single instance of poor quality control. To preserve their reputation,
pharmaceutical businesses work hard to maintain the highest standards.
4. Continuous Improvement:
One of the main objectives of QC department is to ensure the consistent efficiency of the
processes and materials used in the production of the medicine. It can be done be by
ensuring highest possible quality of materials and components supplied by vendors. Also
increase the capability of critical processes to consistently meet specifications.
Steps Involved in the Quality Control Process
1. Raw Materials Testing:
Testing the raw ingredients used in product manufacturing is the first stage. Ensuring that
products satisfy quality standards and are free from contamination is imperative.
2. In-ProcessTesting:
After approval, raw materials are transformed on the manufacturing floor to produce the
final product. Throughout the production process, in-process testing is carried out to
ensure that the medication satisfies all quality requirements.
3. Final Product Testing:
The last step in quality control is testing the finished product. These tests are done to
ensure the content uniformity of the product, to detect any impurity and other assays are
done according to the pharmacopoeia of that drug.
Equipment used in Quality Control Department
Equipment Company Origin Use
Analytical
Test:
Identification
Qualification
HPLC Shimadzu Japan
Separation
Analytical
Test:
Identification
Qualification
HPLC Agilent Germany
Separation
Trace metal
Atomic determination
absorption and metal
Shimadzu Japan
spectrophotomet identification
er
Equipment Company Origin Use
Material
identification and
functional group
FTIR Shimadzu Japan
determination
To measure
total organic
Carbon
TOC Analyzer Shimadzu Japan
inpurified
Water
Conductivity Sartorius Germany To test conductivity
Tester
Sieving machine Fritsch Germany To do sieve analysis
To determine
optical
Automatic Atago Japan
rotation
Polarimeter
PH meter Mettler Toledo Switzerland To determine pH
UV-Visible A wide range
Spectrophotometer analytical
Shimadzu Japan
test
Semi automatic ERWAKA Germany Dissolution testing
Dissolution Taster
Centrifuge machine Hermle Germany Separation
Technique
Equipment Company Origin Use
Controlled
Waterbath GEL Germany Temperature reaction
Microscope Olympus Japan Identification
Drying and to
Vaccum Oven Memmert Germany Check LOD
Weighing Balance Mettler Toledo Switzerland Analytical weighing
Moisture
content
Karl Fischer titrator Mettler Toledo Switzerland
determination
Potency
determination of
Gas - Japan
volatile substance
Chromatography
To measure the
particle no. in solid
Particle Size - USA
and liquid
Analyzer
Major Responsibilities of QC Personnel
1. Source Validation:
Pre-shipment sample validation is done to ensure that drug that will be made by the API and
excipients will remain within the required specification. It is to be ensured that the source is of
highest quality and it can successfully commercialized. Back up source is always kept in hand
and retention sample is kept.
2. Release, Reject, or Quarantine Advice:
Issuing release, rejects, or quarantine advice for each batch of raw, bulk, and packaging
materials after necessary analysis and testings are done.
3. Method Validation:
Both quantitative analysis for checking the potency of the product and qualitative
analysis for checking the physical parameters of the product is done to validate the
method. It is also checked whether the method have required accuracy, precision,
robustness.
4. Control of Laboratory Reagents:
Managing and controlling laboratory reagents. Every chemical and reagent are stored
according to the storage condition mentioned in the Safety Data Sheet (SDS).
Flammable items are kept in “Yellow cabinet”, acid and base are kept in “Ash
cabinet”, toxic and corrosive, health hazard, dangerous for environment these types of
chemicals and reagents are kept in “Red cabinet”.
5. Assessment of Finished Products:
Assessing finished products for release, rejection, etc.
6. Environmental Monitoring:
Conducting environmental monitoring for air quality in Class A, B, C, D areas.
7. Maintaining Test Records:
Maintaining batch- wise full- quality control test records, including the signature of the
personnel performing the tests.
8. Batch Documentation:
Managing documentation related to batches.
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9. Stability Testing:
Sample of product is provided by QA to QC to carry out stability testing and these testing are
done to ensure the shelf-life of the product. Stability testing is carried out in both accelerated and
real time condition. Three batches of follow-up validation batch are done for every drug each
year which can be done for a variety of reasons like API/excipient source change, commercial
batch scale, machinery change. Sample from follow-up batch is also provided to QC. And the
condition of follow-up stability testing is 30°C, 65% RH.
10. Calibration and Standardization:
Calibration and standardization of laboratory equipment based on the type of Instrument.
Instruments are divided in 3 categories, such as – Instrument A, B, C. A type instruments such as
hot plate, water bath are not used to measure any critical parameters of the product and these
instruments are not calibrated by suppliers. B type instruments are used to measure the physical
properties of the product and these types of instruments includes- analytical balance, pH meter,
viscometer, melting point apparatus etc. These instruments are monitored daily and is calibrated by
supplier if critical problem arises. Instrument C types are used to determine critical parameters of
the product and these are calibrated by experts and supplier following the schedule of the master
plan. Preventive maintenance is done by suppliers before scheduled calibration and performance
verification is done in-house.
11. Working Standard:
Working Standard is made from approved raw material which is compared with the main
reference standard. Working standard are made to make the process of medicine production cost
effective because the main reference standards are quite expensive and these standards are
frequently needed for analytical purpose. Working standard are maintained by Laboratory
Information Management System (LIMS).
12. Cleaning Validation:
To ensure the process of cleaning a machine is validated. Samples from only critical point of the
machine are taken. And the area of these critical points is 100 cm square which is determined by
the engineering department. Samples are taken from each step of production such as dispensing,
granulation, compression, coating. And the analysis must be done within 24 hours of receiving
the sample. Two types of tests are done-
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i. Specific test-where identification test is done; HPLC is used
ii. Non-specific- Observes temperature, pH, conductivity. The range of TOC must not be more
than 500 ppb, pH should be with in 5-7, conductivity not more than 1-3 and temperature must
be 25±2 °C.
13. Waste Disposal:
To ensure safe and non-hazardous disposal of waste third party is involved. Safety and
Engineering department prepares a central letter for the total wastage generated from all the
department. This central letter is approved by the head of the QA and finally submitted to the
third party.
14. Ensuring Personal Safety:
Ensuring personal safety of personnel involved in QC activities.
15. Effluent Treatment Plant (ETP) Control:
Controlling the effluent treatment plant.
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