3. CONTENTS:
• Introduction
• GMP
• QC
• WHO Good Practices for Pharmaceutical Quality Control laboratories
• GLP In Pharmaceutical Lab
• Ways to Reduce Human Errors in Pharmaceuticals
• Scope of QA & QC In Pharmaceutical Lab
• Stepwise GLP Implimentation
4. Introduction:
• Pharmaceutical laboratories provide specialist pharmaceutical testing
services, including chemical and physical characterization, formulation
development, microbial, stability and elemental impurity testing on a wide
range of products, from raw materials to finished products.
• Pharmaceutical testing laboratory tests:
• Raw materials
• Finished products
• Methods validation
• Stability testing
• Analytical method development
• Microbiology
5. Laboratory Inspection:
• The laboratory inspection may be limited to specific issues, or the
inspection may encompass a comprehensive evaluation of the
laboratory's compliance with CGMP's.
• In general these inspections may include
• - the specific methodology which will be used to test a new product
• - a complete assessment of laboratory's conformance with GMP's
• - a specific aspect of laboratory operations
6. GMP:
• Good manufacturing practice (GMP) is a system for ensuring that
pharmaceutical products are consistently produced and controlled
according to quality standards.
• The standards are designed to minimize the risks that cannot be
eliminated through testing the final product.
7. GLP in a Pharmaceutical Lab
In pharmaceutical lab, GLP should be followed. Following points should be
considered:
• The laboratory should be located designed, customized and maintained to
suit the performance of all QC test & analysis required.
• Conveniently located to service the Mfg. Dept. but preferably separate to
avoid vibration, dust, internal & external traffic to protect the delicate
instruments.
• As far as possible, there must be separate wings for analytical instruments,
microbiology and sterility etc. and all wings may be interconnected with the
internal door.
8. Continued..
• There must be an effective airlock, provisions for A.C. & fumigation
chamber, the laboratory should be so designed that not only adequate
provision of space but provision for utility, water, solvent storage,
extraction dust collection etc. were covered.
• Laboratory furniture so designed to provide for adaptability, tabletop
must be covered properly resistant to acid, alkali & solvent etc. The
floor should be smooth, easy to clean & adequate drainage facility.
10. Quality Control
What is Quality?
• Quality is the entity of a product (service) which fulfills the defined &
expected requirement.
• The customer checks if the product meets the requirements.
• 3 E in Quality:
I. Effectiveness extent to which planned activities are realized &planned
results achieved.
II. Efficiency relationship b/w results achieved & resources used.
III. Excellence doing the right things right.
11. QC in a Pharmaceutical Lab
• ISO: activities and techniques applied to ensure that products
consistently fulfil requirements
• Clinical Research: systematic checks on the compliance of the trial
process & reliability and credibility of data.
• All measures taken, including the setting of specification, sampling,
testing & analytical clearance, to ensure that raw materials,
intermediates, packaging materials and finished pharmaceutical
products conform with established specifications for identity, strength,
purity and other characteristics.
12. Functions of QC in Pharmaceutical Lab:
• Preparation of specifications for testing of materials and products.
• Carrying out Sampling and testing of materials or products.
• Environment Monitoring
• Conducting stability studies.
• Investigating test failures
• Analytical Method validation
• Evaluation of complaint samples.
• All the quality control activities are performed
• Adherence to the GLP.
13. WHO Good Practices for Pharmaceutical
Quality Control laboratories
This QC training module consists of 4 parts:
• Part 1: Management and Organization
• Part 2: Materials, equipment, instruments and devices
• Part 3: Working procedures and documents , and safety in the lab
• Part 4: inspecting the laboratory
14. Part 1: Management and infrastructure
• Organization & management
• Quality system
• Control of documentation
• Records
• Data processing equipment
• Personnel
• Premises
• Equipment, instruments and other devices.
15. Part 2: Materials and set-up of equipment,
instruments and other devices
• Specifications archive
• Reagents
• Reference materials
• Calibration, validation and verification of equipment, instruments and
other devices
• traceability
16. Part 3: Working Procedures
• Incoming sample
• Analytical worksheet
• Testing
• Evaluation of test results
• Retained samples
Part 4: Safety in pharmaceutical control
laboratories
• General rules
17. Quality Assurance in Pharamaceutical
Lab:
• In the pharmaceutical industry, quality assurance (QA) is essential for
ensuring that pharmaceutical products are manufactured to a safe and
consistent standard.
• QA is a very broad field that refers to any aspect that may affect a
drug’s quality during its research, development, manufacturing, and
sales phases.
• QA professionals are responsible for instituting a range of practices
that help guarantee a drug’s quality.
18. Quality Assurance Training Helps Ensure
Drugs Work Safely and as Intended
• A drug that doesn’t work as intended or that is defective in some way
can present a threat to public health.
• Ensuring that pharmaceutical products are safe and effective is the
primary goal of any pharmaceutical company’s QA department. There
are a number of methods and procedures QA departments use to
achieve this goal.
• For example, QA professionals test for drug stability, which is a
measure of how consistent a pharmaceutical product’s chemical,
therapeutic, physical, and other properties remain over time and in
certain conditions.
19. Contd..
• A drug that degrades when
exposed to different
environmental conditions may
have an adverse impact on
patients, which is why QA
professionals investigate if a
drug’s chemical properties
change if it is stored at a certain
temperature. The results of these
investigations can help drug
manufacturers develop
guidelines for safe and proper
storage of the drug.
20. Quality Assurance Helps Pharmaceutical
Companies Stay in Compliance with the Law
• Due to their impact on public health, pharmaceutical products and
pharmaceutical QA are highly regulated.
• There are many laws and rules that pharmaceutical companies must
comply with before they can sell and market a pharmaceutical product.
• Part of a QA professional’s job is to assist companies with regulatory
compliance, which can be achieved in a number of ways.
21. Contd..
• A QA professional implements
various measures at
manufacturing facilities, such as
calibrating equipment,
maintaining documentation, and
conducting quality tests, that are
covered by GMP and that can
help a facility pass its inspection.
22. Quality Assurance Training Helps
Pharmaceutical Companies Maintain Their
Reputations
• The public wants assurances that the pharmaceutical drugs they take
are safe and useful.
• If a pharmaceutical manufacturer is found not to be in compliance
with QA regulations, or if they have created a pharmaceutical product
that is either unsafe or doesn’t work as intended, the public may lose
faith in the quality of that company’s products.
• By ensuring that measures are in place to guarantee product quality, a
QA professional plays a significant role in reassuring the public that a
certain drug—and, by extension, that drug’s manufacturer—can be
trusted.
23. 6 Ways to Reduce Human Errors in
Pharmaceuticals:
• Human errors have critical effects on pharmaceutical product quality .
About 80% of the product quality issues occur due to human errors, which
are traced by deviations in the process. They occur due to improper
communication or failure to follow the written procedure.
• Following are some solutions to minimize the human errors:
1. Identify the Error Reduction Opportunities:
The space where a human error can occur must be identified in the
manufacturing & QC. It should be identified separately for the equipment,
documentation and systems where improvements can be done.
24. Continued…
2. Redesign procedures:
Make required changes in SOP`s & formats to make them easy, short and clear.
Remove the sections from procedures which are not useful.
3. Improve supervision:
Instructions to the workers & pharmacists should be given at every stage of
manufacturing by the supervisors. Supervisors should be on the floor not in the
office.
4.Improve communication:
Lack of communication in different shifts causes a lot of problems.
Communication between QA & manufacturing department should be proper at
every stage.
25. Continued…
5. Job Assignment:
Performance of the individual personnel should be monitored by
supervisor & job should be assigned according to their capabilities. It
gives better results and reduces the chances of errors.
6. Training:
On job training is necessary to all workers for all critical activities.
Training should include all possible human errors & related question
that may occur during the process.
26. Pharmaceutical Testing
Whether you are performing the testing on site or utilize services from a
pharmaceutical testing company, the various studies and validations include:
• Potency
• Purity
• pH
• Microbial and fungal identification
• Antimicrobial effectiveness testing
• Dissolution
• Stability testing
27. Scope of QA & QC In Pharmaceutical Lab:
SR No Criteria Quality Assurance Quality Control
1. Focus To prevent defects with a focus on
the process.
To identify defects in
the finished product.
2. Goal To improve development and test
processes so that defects do not arise.
To identify defects
after a product is
developed and before
it's released.
3. How Establish a good quality management
system & assessment of its adequacy
with continuous monitoring.
Finding sources of
quality problems to
continually meet
customer's
requirement.
28. Continued..
Sr No Criteria Quality Assurance Quality Control
4. What Prevention of quality problems
through planned and
systematic activities.
Analytical techniques
used to maintain the
product quality and
process.
5. Responsibility Everyone on the team. Of a specific team that
tests the product for
defects
6. As a Tool QA is a managerial tool QC is a corrective tool
