Quality Control of Pharma Products and their importance.pdf

Quality Control (QC) of Pharmaceutical Products
Quality control in pharmaceuticals involves the systematic testing of raw materials, intermediates, and finished products to ensure they meet specified safety, efficacy, and quality standards. It includes physical, chemical, biological, and microbiological tests to verify identity, purity, potency, and consistency. QC ensures compliance with regulatory requirements and prevents substandard products from reaching
consumers.

1. VIVEKANANDHA ARTS AND SCIENCE COLLEGE FOR WOMEN
VEERACHIPALAYAM,SANKAGIRI,SALEM,TAMILNADU .
DEPARTMENT OF MICROBIOLOGY
SUBJECT : MICROBIAL QUALITY CONTROL AND TESTING
TOPIC : QUALITY CONTROL OF PHARMA PRODUCTS
Dr.V.BHARATHI,
ASSISTANT PROFESSOR,
DEPARTMENT OF MICROBIOLOGY,
VIVEKANANDHA ARTS AND SCIENCE COLLEGE
FOR WOMEN,SANKAGIRI,SALEM,TAMILNADU.
V.ABINAYA,
II - M.sc MICROBIOLOGY,
VIVEKANANDHA ARTS AND SCIENCE
COLLEGE FOR
WOMEN,SANKAGIRI,SALEM,TAMILNADU.
SUBJECT INCHARGE SUBMITTED BY

2. • INTRODUCTION
•IMPORTANCE OF QUALITY CONTROL OF
PHARMACETICAL PRODUCTS.
•STEPS IN PHARMACEUTICAL QUALITY CONTROL.
•PHARMACEUTICAL GUIDELINES.
•CONCLUSION.
CONTENT

3. •The term quality control refers to the sum of all
procedures undertaken to ensure the identity
and purity of a particular pharmaceutical
product.
•Such procedures may range from the
performance of simple chemical experiments
which determine the identity and screening for
the presence of particular pharmaceutical
substance to more complicated requirements of
pharmacopoeial monographs.
INTRODUCTION TO QUALITY CONTROL OF
PHARMACHEUTICAL PRODUCTS

4. •The quality of a product may deviate from the standa required so
carrying out analysis is important in order to determine the
quality.
•Testing a pharmaceutical product involves chemical, physical,
and some time microbiological evaluation or test.
•Quality control is a critical aspect of pharmaceutical
manufacturing that ensures the quality, safety, and efficacy of
pharmaceutical products.
•The primary goal of quality control is to guarantee that
pharmaceutical products meet the required standards of identity,
strength, quality, and purity.

5. IMPORTANCE OF QUALITY CONTROL IN PHARMACEUTICALS
• Ensures patient safety and well-being.
•Prevents harm from adulterated or contaminated products.
•Maintains public trust in pharmaceutical products.
•Complies with regulatory requirements and industry standards.
•Supports the reputation and credibility of pharmaceutical
companies.

6. STEPS IN PHARMACEUTICAL QUALITY CONTROL
• Pharmaceutical quality control
involves a series of steps to ensure
pharmaceutical products' safety,
efficacy, and consistency.
• These steps are critical in meeting
regulatory requirements and
maintaining product quality.

8. SAMPALING
The process begins with the
collection of samples from
various stages of production,
including raw materials, in-
process materials, and finished
products.
Sampling is done according to
established procedures and
sampling plans.
TESTING AND ANALYSIS
The collected samples undergo
various tests and analyses.
Depending on the product type,
these may include chemical, physical,
microbiological, and pharmacological
tests.
The tests are conducted in
accordance with established testing
methods and pharmacopeia standards.

9. All analytical instruments and
equipment used in testing must
be regularly calibrated to ensure
their accuracy and reliability.
Calibration records are
maintained to demonstrate
instrument performance.
INSTRUMENT CALIBRATION
Detailed test results, procedures, and
observation records are meticulously
maintained.
Proper documentation is crucial for
traceability, accountability, and
regulatory compliance.
DATA RECORDING AND
DOCUMENTATION

10. Trained analysts review and
interpret the test results, comparing
them to established specifications
and standards.
Deviations from specifications are
identified and investigated.
REVIEW AND
INTERPRETATION
If a sample fails to meet established
specifications, an OOS investigation is
initiated to determine the cause of the
deviation.
Corrective and preventive actions
(CAPA) are implemented to address
the issue and prevent recurrence.
OUT-OF-SPECIFICATION (OOS)
INVESTIGATION

11. Stability studies evaluate how the
product changes over time under
different storage conditions.
This helps determine shelf-life and
appropriate storage recommendations.
STABILITY TESTING
Quality control personnel review
all data and documentation to
ensure compliance with
established procedures and
regulatory requirements.
DOCUMENTATION REVIEW

12. Based on the review of testing data,
products are either released for
distribution if they meet specifications
or rejected if they do not.
The release decision is made by
qualified personnel.
RELEASE OR REJECT
DECISION
All quality control records,
including test results, batch
documentation, and
investigations, are archived and
maintained for a specified period,
as regulatory authorities require.
RECORD KEEPING

13. Quality control may generate
reports summarizing testing results,
OOS investigations, and other relevant
information.

These reports can be shared with
regulatory agencies as required.
REPORTING
The quality control process
includes feedback mechanisms
to improve processes and
prevent future quality issues
continually.
CONTINUOUS IMPROVEMENT

14. •These guidelines are established by various regulatory
bodies, including the United States Food and Drug
Administration (FDA).
•European Medicines Agency (EMA).
•International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use (ICH).
PHARMACEUTICAL GUIDELINES FOR QUALITY CONTROL

15. SOME KEY PHARMACEUTICAL GUIDELINES FOR QUALITY CONTROL
Good Manufacturing Practices (GMP) :-
GMP guidelines provide comprehensive standards for the manufacturing,
testing, and quality control of pharmaceutical products. They cover facility
design, personnel training, documentation, and qualityassurance.
Good Laboratory Practices (GLP) :-
GLP guidelines focus on the quality and integrity of laboratory data
generated during pharmaceutical development and testing. They ensure that
testing and analytical procedures are accurate and reliable.

16. Pharmacopeia Standards:
Pharmacopeias like the United States Pharmacopeia (USP) and the European
Pharmacopoeia (Ph. Eur.) establish standards for the quality of pharmaceutical
ingredients and finished products. Compliance with these standards is often mandatory.
ICH Guidelines:
The International Council for Harmonization (ICH) develops guidelines that
harmonize regulatory requirements across regions, ensuring consistency in quality
control practices.
Validation Guidelines:
Validation guidelines outline procedures for validating equipment, analytical
methods, and processes to ensure they perform as intended and consistently produce
quality products.

17. Stability Testing Guidelines:
These guidelines specify the requirements for conducting stability studies to
determine pharmaceutical products' shelf-life and storage conditions.
Data Integrity Guidelines:
These guidelines emphasize the importance of maintaining accurate and
reliable data throughout product development and manufacturing processes.
Quality Risk Management:
Quality control guidelines also advocate using risk management principles to
identify, assess, and mitigate risks that could impact product quality.

18. The Effective quality control measures, including raw materials control, in-process
control, finished product control, and stability testing, help to
1. Prevent contamination and adulteration,
2. Ensure consistency and reliability,
3. Detect and correct deviations,
4. Maintain regulatory compliance.
The Quality control in pharmaceutical products is essential for protecting public
health and ensuring that patients receive safe and effective treatments. By
prioritizing quality control, pharmaceutical companies can maintain the trust of
patients, healthcare professionals, and regulatory authorities.
CONCLUSION

19. https://www.compliancequest.com/quality/pharmaceutical-quality-control/
https://www.who.int/teams/health-product-and-policy-
standards/standards-and-specifications/norms-and-standards-for-
pharmaceuticals/guidelines/quality-control
https://www.slideshare.net/slideshow/quality-control-of-pharmaceutical-
products-31353025/31353025. https://blog-nbs--us-
com.cdn.ampproject.org/v/s/blog.nbs-us.com/steps-of-quality-control-in-
the-pharmaceutical-industry. https://www.slideshare.net/slideshow/quality-
control-of-drugs-and-pharmaceuticals/250379458.
References

20. THANK
YOU
"Pure Quality , Pure care
Your Health is Our Priority"....