This document summarizes the functions of a pharmaceutical quality control laboratory. It discusses that quality control ensures manufactured products adhere to defined quality standards and are safe, effective and of good quality. The document then outlines various aspects of operating a quality control lab, including complying with good laboratory practices (GLP), good manufacturing practices (GMP) and ISO/IEC 17025. It discusses documentation, personnel, equipment, contracts, reference substances, calibration, verification, and qualifications. Finally, it summarizes procedures for sampling, testing, validating, evaluating and reporting analytical results.

1. Pharmaceutical Quality
Control Laboratory
Presented By: Group 06
BCH 7th Semester
(Evening)
Submitted To: Dr. Nafeesa
Hanif
Course Name: GLP

2. Group (6) Members:
• Farwa Zakir (20-Arid-2308)
• Isha Maryam (20-Arid-2313)
• Zinnia Rashad (20-Arid-2340)
• Bibi Saira (20-Arid-2305)
• Faryal Nadeen (20-Arid-2309)
• Haseeb Ahmad (20-Arid-2312)
• Shahiq ul Hassan (20-Arid-2333)

3. Pharmaceutical Quality
Control Lab
• 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.
• A pharmaceutical quality control
lab is a place where scientists test
medicine and other products to
make sure they are safe, effective
and of good quality.
Shahiq ul Hassan
20-Arid-2333

4. QC in pharmaceutical
• Quality control is an essential operation of the pharmaceutical industry
• Drugs must be marketed as safe and therapeutically active formulations whose
performance is consistent and predictable
• New and better medicinal agents are being produced at an accelerated rate. At the
same time more exacting and sophisticated analytical methods are being developed
for their evaluation.
• The 4 Main responsibilities of quality control in pharmaceutical industry include:
 Efficacy
 Quality
 Safety
 Compliance

5. Objectives of QC in pharmaceutical
• Establishment of quality standard
• Locating quality deviations
• Evaluating method and process of production
• Quick sales quality goods
• Production of standard quality goods
• Improvement in quality

6. Imprtance of QC in pharmaceutical
• The pharmaceutical environment today is changing quickly due to
globalization,increased competition , increased cost constraints ,demand for
efficiency ,product complexity etc .in this fast changing environment the people and
companies that learn to adopt will prosper
• To manufacture and deliever zero defect products to the patients
• The quality ,efficacy and safety attributes of product must be ensured so that the
costumer health is not compromised

7. The Regulatory and Ethical Requirement for
PQCL
GLP (Good Laboratory Practice):
GLP stands for Good Laboratory Practice, which is a set
of principles and guidelines for conducting non-clinical
studies that support or are intended to support applications
for research or marketing permits for products regulated
by government agencies.
GLP aims to ensure the quality, integrity, and
reliability of the data generated by the studies
Isha Maryam
20-Arid-2313

8. GMP (Good Manufacturing Practice):
GMP stands for Good Manufacturing Practice,
which is a system for ensuring that products are
consistently produced and controlled according to
quality standards. GMP covers all aspects of
production from the starting materials, premises,
and equipment to the training and personal hygiene
of staff.
GMP ensures that the products are safe,
effective, and fit for their intended use

9. ISO/IEC 17025
ISO/IEC 17025 is an international standard that
specifies the general requirements for the
competence, impartiality, and consistent operation
of testing and calibration laboratories. ISO/IEC
17025 covers the management and technical aspects
of laboratory activities, such as personnel,
equipment, methods, procedures, quality control,
and reporting.
ISO/IEC 17025 accreditation provides formal
recognition of the laboratory’s competence and
credibility.

10. Continue.......
These requirements apply to PQCLs in different ways, depending on the type and scope
of the testing or calibration activities they perform, the regulatory authorities they work
with, and the customers they serve.
For example, some PQCLs may need to comply with GLP for conducting non-clinical
studies for drug development, GMP for testing the quality of drug products, and
ISO/IEC 17025 for demonstrating their technical competence and quality management
system.
Other PQCLs may only need to comply with one or two of these requirements,
depending on their specific situation. In any case, PQCLs should follow the
relevant requirements to ensure the quality, safety, and efficacy of the
pharmaceutical products they test or calibrate

11. Organization and Regulation of
pharmaceutical Quality control
Laboratory
• Quality Management System (QMS):
The foundation of a QCL lies in its QMS, which comprises policies,
procedures, processes, and resources used to ensure product quality.
This system adheres to regulatory standards (such as cGMP – current
Good Manufacturing Practices) and encompasses quality planning,
control, assurance, and improvement. Bibi Saira
20-Arid-2305

12. • Documentation and Records:
Accurate and comprehensive documentation is vital in a PQCL. This includes SOPs
(Standard Operating Procedures), test methods, specifications, validation protocols,
calibration records, and reports. Proper maintenance of records ensures traceability,
facilitates audits, and demonstrates compliance with regulatory requirements
• Personnel:
The PQCL requires trained and qualified personnel to conduct analyses and oversee
quality control processes. This includes chemists, microbiologists, analysts, and quality
assurance professionals. Training programs, qualifications, and ongoing education are
essential to ensure competency and adherence to protocols

13. • Premises:
The laboratory’s physical environment must meet specific standards for cleanliness,
temperature control, safety, and adequate space to prevent contamination and ensure
accurate testing. Compliance with regulatory guidelines for laboratory design and
maintenance is
crucial.
• Equipment:
Accurate and validated equipment is integral to PQCL operations. This
includes analytical instruments (HPLC, GC, spectrophotometers),
balances, incubators, and more. Calibration, validation, maintenance,
and qualification of equipment are essential to ensure accuracy and
reliability of test results

14. • Contracts:
PQCLs often engage in contracts for services, such as outsourcing specialized tests or
collaborating with third-party laboratories. Contracts outline responsibilities, quality
standards, confidentiality agreements, and compliance with regulatory requirements.

15. Reagent,reference substances,callibration and verification
devices and Qualification
Reference Substances
Definition: Highly pure and well-characterized materials.
Purpose: Used for comparison, calibration, and validation.
Role: Benchmark for accurate and reliable analytical results.
Functions: Validate methods, verify instrument performance, and maintain product quality.
Importance:Critical in ensuring consistency and quality during testing in pharmaceutical
laboratories.
Reagents
• Titration solutions
• Reference standards for calibration
• Solvents
• Reagents for chromatography, spectroscopy, and assays, depending on testing methods.
•Indicators
•Buffers
Zinnia Rashad
20-Arid-2340

16. Devices used for Calibration:
• Calipers:Measure dimensions of objects with high precision.
• Weights: Used for calibrating scales and balances.
• Pressure Gauges: Calibrated to ensure accurate pressure readings.
• Thermocouples: Devices to calibrate temperature-measuring instruments.
• Multimeters: Calibrated for accurate electrical measurements.
• pH Meters: Calibration ensures accurate pH readings.
• Flow Meters: Calibrated to ensure accurate flow rate measurements.
• Spectrophotometers: Calibration ensures accurate absorbance and concentration
readings.
• Gas Detectors:Calibrated for precise gas concentration measurements.

17. Verification
• Instrument Calibration: Regular verification of analytical instruments to maintain
accuracy.
• Method Verification: Confirming that testing methods are accurate, reliable, and meet
regulatory standards.
• Quality Control Standards:Verifying that reference substances and reagents adhere to
defined quality standards.
• Data Verification: Ensuring accuracy and integrity of data through review and
validation.
• Equipment Validation
• Compliance Verification
• Training Verification
• Environmental Monitoring

18. Qualification:
• Educational Background: Bachelor’s or Master’s degree in a relevant field (e.g.,
Chemistry, Pharmacy, Biochemistry).
• Technical Skills: Proficiency in analytical techniques (e.g., chromatography,
spectroscopy).
• Regulatory Knowledge: Understanding of Good Laboratory Practices (GLP) and
regulatory guidelines.
• Documentation Skills: Ability to maintain accurate and detailed records.
• Attention to Detail: Precision and accuracy in conducting tests and interpreting
results.
• Problem-Solving Skills: Ability to troubleshoot and address unexpected issues.
• Communication Skills: Clear communication of results and documentation.
• Computer Proficiency: Familiarity with laboratory information management systems
(LIMS) and data analysis software.

19. The working procedures and Methods for Sampling,
Testing, Validation, Evaluating and Reporting of
analytical results
• Sampling:
This involves selecting a representative sample of the material or product to be tested,
ensuring its integrity and traceability, and preparing it for analysis. Sampling should
follow a written protocol that specifies the sampling plan, the sampling method, the
sample size, the sample labeling, the sample storage, and the sample transportation
Farwa Zakir
20-Arid-2308

20. • Testing:
This involves performing the analytical method on the sample, following the written
procedure that describes the apparatus, equipment, reagents, standards, operating
parameters, system suitability, and calculation of results.
Testing should be done by qualified and trained personnel, using calibrated and
validated instruments, and following good laboratory practices (GLP).
• Validation:
This involves demonstrating that the analytical method is suitable for its intended
purpose, by verifying its accuracy, precision, specificity, linearity, range, detection limit,
quantitation limit, robustness, and ruggedness.
Continue...

21. Continue..
• Evaluation:
This involves comparing the analytical results with the acceptance criteria, specifications,
or reference values, and determining whether the sample passes or fails the test.
• Reporting:
This involves presenting the analytical results in a clear, concise, and complete manner,
following the format and content required by the customer or the regulatory authority.
Reporting should include the sample identification, the analytical method, the test results,
the acceptance criteria, the conclusion, and any deviations, anomalies, or remarks.
Reporting should also include the signature, name, and date of the analyst and the
reviewer.

22. Continue..
These are some of the general steps for the working procedures and methods for
sampling, testing, validation, evaluating and reporting of analytical results in PQCL.
However, each PQCL may have its own specific procedures and methods, depending on
the nature and scope of the analysis, the regulatory requirements, and the quality
standards. Therefore, it is important to consult the relevant guidelines, protocols, and
manuals for each PQCL before performing any analysis.

23. The safety measures and precautions for handling
hazard substances and preventing contamination
Working in Pharmaceutical quality control laboratory
• Hazardous substances:
“A hazardous substance is any material which can cause harm to you either directly
or indirectly. You may encounter hazardous substances either during the sampling or
in the working environment where you are conducting the sampling.”
Faryal Nadeem
20-Arid-2309

24. Types of hazardous material
• Explosives
• Flammable Liquid and Combustible Liquid
• Flammable Solid, Spontanaeously Combustible and Dangerous
When Wet
• Oxidizer
• Gases

25. Safety measures and precautions:
• Handling hazardous substances requires careful attention and adherence
to safet protocols to ensure well being of individual and prevent
contamination.Safety measures and precautions for handling hazardous
substances are
• Personal protective equipment
• Proper storage Of hazardous substances
• Handling and transportation
• Ventilation
• Waste disposal
• Emergency preparedness

26. Working inPQCL:
• Working in a pharmaceutical quality control laboratory involves ensuring that
products meet the required standards and specifications.
Instrumentation Skills
Training
Documentation
Quality Assurance
Safety
Sample Handling
Calibration
Testing and Analysis

27. Conclusion:
 Handling hazardous substances requires strict adherence to safety measures and
precautions to protect individuals and prevent contamination.
 By following proper protocols for personal protective equipment, storage, handling,
ventilation, waste disposal, and emergency preparedness, the risk of accidents and
contamination can be significantly minimized.

28. Challenges And Oppurtunities of PQCL
Pharmaceutical Quality Control (QC) laboratories play a crucial role in
ensuring the safety, efficacy, and quality of pharmaceutical products. However,
like any other field, they face several challenges and opportunities
1.Challenges:
i. Regulatory Compliance
ii. Technological Advancements
iii. Data Management
iv. Personnel Training
v. Sample Volume and Turnaround Time
vi. Globalization and Supply Chain Complexity
vii. Environmental Monitoring
Haseeb Ahmad
20-Arid-2312

29. CONTD…
2. Opportunities:
i. Advanced Analytical Technologies
ii. Automation and Robotics
iii. Data Analytics and AICollaboration and Networking
iv. Regulatory Alignment
v. Sustainability Initiatives
vi. Continuous Improvement Culture

30. Ethical and Social Implications for Developing Countries
1. Ethical Implications
i. Patient Safety
Ensuring the quality of pharmaceutical products through rigorous quality control is
an ethical imperative to safeguard the health and well-being of patients. Substandard or
counterfeit drugs can have severe consequences for individuals and communities.
ii. Equitable Access to Quality Healthcare
include the need for equitable access to high-quality medicines. Developing countries
often face challenges in accessing affordable, safe, and effective medications.
Implementing robust quality control processes contributes to addressing this ethical
concern

31. iii. Clinical Trials and Informed Consent
Ethical pharmaceutical quality control involves adherence to standards in the
conduct of clinical trials. Ensuring that participants in these trials are fully
informed and have given their voluntary consent is crucial
iv. Transparency and Accountability
Ethical pharmaceutical practices demand transparency in reporting and
accountability in the manufacturing and distribution processes. This is essential
to maintain public trust in the pharmaceutical industry
v. Preventing Exploitation
Developing countries may be vulnerable to the importation of substandard
drugs. Ethical quality control measures help prevent the exploitation of
vulnerable populations through the sale of low-quality or ineffective
pharmaceuticals
CONTD...

32. Social Implications
i. Public Health Impact
 Substandard or counterfeit drugs can have severe consequences on public
health, leading to treatment failures, increased morbidity, and mortality.
Robust quality control is essential to mitigate these social impacts
ii. Economic Burden
 The use of poor-quality pharmaceuticals can result in increased healthcare
costs due to prolonged illnesses, hospitalizations, and the need for
additional treatments. This places an economic burden on both individuals
and the healthcare system
iii. Access to Essential Medicines
 Quality control processes impact the availability of essential medicines.
Adequate quality control ensures that vital medications are accessible to
those who need them, contributing to the overall well-being of communities

33. CONTD...
iv. Trust in Healthcare Systems
Ensuring the quality of pharmaceuticals builds trust in healthcare systems. This
trust is vital for encouraging individuals to seek medical care, comply with
treatment regimens, and participate in public health initiatives
v. Capacity Building and Local Industry
Implementing quality control measures can lead to capacity building in local
industries. This not only enhances the skills and knowledge of the workforce but
also supports the growth of a sustainable pharmaceutical sector in developing
countries
vi. International Collaboration and Aid
Adhering to high-quality standards in pharmaceuticals facilitates international
collaboration and aids. It encourages partnerships between developed and
developing countries, promoting the exchange of knowledge, resources, and
technologies