Good Manufacturing Practice and Quality Control.pdf

This is the process that goes into making sure good quality medication is made.

1. Good Manufacturing Practice
and Quality Control
Third years

2. Introduction
•Quality assurance (QA) and quality control (QC) are
two fundamental components of quality management
systems that organizations use to ensure the quality of
their products or services.
•While they are closely related, they serve distinct
purposes and involve different processes

3. Principles of Quality Assurance (QA):
•Customer Focus:QA starts with a deep understanding of customer
requirements and expectations. It aims to ensure that the final
product or service meets or exceeds these expectations.
•Process-Oriented:QA is process-oriented and focuses on preventing
defects and issues from occurring in the first place. It involves
defining and implementing standardized processes.
•Continuous Improvement:QA promotes a culture of continuous
improvement. Organizations should regularly review and enhance
their processes to achieve higher levels of quality.

4. QA
•Quality assurance focuses on preventing defects through
process management and improvement, while quality
control is about detecting and correcting defects in the final
product. Both QA and QC are critical for delivering high-
quality products or services that meet customer
expectations. An effective quality management system
integrates these principles to ensure consistent quality
throughout an organization's operations.

5. QA
•Top Management Commitment:Senior management must be
committed to and actively involved in QA initiatives. They should set
quality objectives and provide necessary resources.
•Training and Development:Providing training and development
opportunities ensures that employees have the skills and knowledge
required to execute QA processes effectively.
•Measurement and Analysis:QA relies on data and metrics to
evaluate process performance and product quality. Regular
monitoring and analysis help identify areas for improvement.

6. QA
•Documentation and Standardization:QA emphasizes documenting
processes, procedures, and standards to ensure consistency and
repeatability.
•Risk Management:Identifying and mitigating risks is an essential part
of QA. This includes both internal and external risks that can impact
product or service quality.
•Customer Feedback:QA systems should incorporate mechanisms for
collecting and acting upon customer feedback to drive improvements.

7. Principles of Quality Control (QC):
•Inspecting and Testing:QC involves inspecting, testing, or sampling
products or services to identify defects or non-conformities.
•Corrective Action:When defects are found, QC focuses on taking
corrective action to fix them before products are released to
customers.
•Product-Oriented:QC is product-oriented and aims to identify and
address issues with the final output.
•Verification:QC verifies that products or services meet established
quality standards and specifications.

8. QC
•Sampling Techniques:QC often employs statistical sampling
techniques to assess the quality of a representative sample of
products rather than inspecting every item.
•Non-Conformance Management:QC establishes procedures for
handling non-conforming products, including disposition (e.g.,
rework, scrap, or retesting).
•Documentation:QC maintains detailed records of inspections, tests,
and outcomes to demonstrate compliance with quality standards.
•Traceability:QC ensures that products and their components can be
traced back to their source, making it possible to investigate and
address quality issues.

9. QC
•Feedback Loop:QC can provide valuable feedback to QA by
highlighting areas where process improvements are needed.
•Objective Evaluation:QC activities are objective and focused on
measurable criteria to determine product acceptability.

10. Questions/quiz
1.Which of the following is primarily concerned with preventing defects before they occur?
a) Quality Control (QC)
b) Quality Assurance (QA)
c) Quality Improvement (QI)
d) Quality Inspection (QI)
2. What is the primary goal of quality control?
a) To design effective processes
b) To prevent defects in products or services
c) To continuously improve products or services
d) To gather customer feedback
3. Which phase of the production process is typically associated with quality control activities?
a) Design
b) Manufacturing
c) Marketing
d) Sales

11. Current Good Manufacturing for finished
products (cGMP)
•Current Good Manufacturing Practice (cGMP) for finished
pharmaceuticals is a set of regulations and guidelines
established by regulatory authorities, such as the U.S. Food
and Drug Administration (FDA) and the European Medicines
Agency (EMA), ZAMRA to ensure the quality, safety, and
efficacy of pharmaceutical products. Here are some key
terms and concepts commonly used in cGMP for finished
pharmaceuticals:

12. Terms
•Batch Record:A comprehensive document that includes all the
information about the manufacturing, packaging, and testing of a
specific batch of a pharmaceutical product. It serves as a historical
record of the batch's production.
•Validation:The process of demonstrating and documenting that a
system, process, or method is capable of consistently producing
pharmaceutical products that meet predetermined quality
specifications.
•Standard Operating Procedures (SOPs):Written instructions detailing
the steps and methods for performing specific manufacturing, testing,
or quality control processes consistently.

13. Terms cont..
•Change Control:A systematic process for proposing, evaluating,
approving, and implementing changes to pharmaceutical processes,
equipment, facilities, or materials to maintain product quality and
regulatory compliance.
•Out of Specification (OOS):Test results or product characteristics that
fall outside established acceptance criteria. OOS results trigger
investigation and may lead to product rejection or retesting.
•Batch Release:The formal review and approval process that allows a
batch of pharmaceutical product to be released for distribution. It
ensures that the batch meets all quality and safety requirements.

14. Terms cont..
•Critical Process Parameters (CPPs):The specific parameters and
variables within a manufacturing process that, if not controlled within
defined limits, could affect the quality and performance of the
finished pharmaceutical product.
•Quality Risk Management:A systematic process for assessing,
controlling, and mitigating risks that could impact product quality and
patient safety.
•Deviation:Any departure from established procedures or
specifications during the manufacturing or testing of pharmaceutical
products. Deviations are investigated and documented.

15. Terms cont…
•Audit and Inspection:Formal reviews and evaluations of
pharmaceutical manufacturing facilities and processes to ensure
compliance with cGMP regulations and guidelines.
•Cleaning Validation:The process of confirming that cleaning
procedures for equipment used in pharmaceutical manufacturing are
effective in preventing cross-contamination.
•Master Production Record (MPR):A document that provides
comprehensive instructions for the manufacture of a specific
pharmaceutical product, including specifications, procedures, and
controls.

16. Qustions/quiz
1. Which of the following is NOT a key element of cGMP?
a) Validation of processes and equipment
b) Document control and record-keeping
c) Maximizing production efficiency
d) Quality risk management
2. What is the primary goal of the batch release process in cGMP?
a) To maximize batch production
b) To expedite product distribution
c) To ensure that the batch meets quality standards
d) To minimize documentation
3. What does OOS refer to in cGMP?
a) Out of Stock
b) Out of Specification
c) On-site Safety
d) Operational Standard

17. Procedures within various components of
cGMP
•Current Good Manufacturing Practice (cGMP) for finished
pharmaceutical products encompasses various components
and procedures aimed at ensuring the quality, safety, and
efficacy of pharmaceuticals.
•Here are procedures within some key components of cGMP:

18. Personnel:
•A) Training and Qualification:Establish procedures for training
employees on cGMP requirements, job-specific tasks, and safety
protocols. Ensure that personnel are qualified for their roles.
•b) Hygiene and Gowning:Define procedures for maintaining personal
hygiene and appropriate gowning practices in cleanrooms and
controlled areas.

19. Facilities and Equipment:
•a Cleaning and Maintenance:Develop cleaning and maintenance
procedures for manufacturing equipment and facilities to prevent
contamination and ensure proper functionality.
•b) Equipment Qualification:Establish procedures for equipment
qualification, including installation, operational, and performance
qualification (IQ/OQ/PQ) to ensure equipment meets intended
specifications.
•c) Environmental Monitoring:Define procedures for monitoring
environmental conditions, such as temperature, humidity, and
particle counts, in critical manufacturing areas.

20. Materials Management:
•a) Raw Material Receipt and Testing:Develop procedures for
receiving, inspecting, and testing raw materials to ensure they meet
quality specifications before use in manufacturing.
•b) Storage and Handling:Establish guidelines for the proper storage
and handling of raw materials, intermediates, and finished products
to prevent contamination and degradation.
•c) Inventory Control:Implement procedures for maintaining accurate
inventory records and ensuring that materials are used on a first-in,
first-out (FIFO) basis.

21. Production:
•A) Batch Record Keeping:Develop procedures for documenting all
manufacturing steps and activities in batch records, including specific
instructions for each production batch.
•b) Process Validation:Define procedures for process validation, which
involves documenting and demonstrating the consistency and
reliability of manufacturing processes.
•c) Cleaning Validation:Establish procedures for cleaning validation to
ensure that equipment and manufacturing areas are effectively
cleaned to prevent cross-contamination.

22. Batch Release and Distribution:
•Batch Release Procedures:Define procedures for batch review,
approval, and release by the quality unit before products can be
distributed.
•b) Traceability:Establish procedures for traceability to track the
movement of products from manufacturing through distribution to
ensure accountability and recall readiness.

23. Quality Risk Management:
•A) Risk Assessment:Develop procedures for conducting risk
assessments to identify, evaluate, and mitigate risks that could impact
product quality and patient safety.
•b) CAPA (Corrective and Preventive Actions):Implement procedures
for initiating, investigating, and documenting CAPAs in response to
deviations, complaints, or non-conformances.

24. Question /quiz
1. Batch release procedures in cGMP involve:
a) Immediate distribution without review.
b) Review, approval, and release by the quality unit before distribution.
c) Skipping the batch release step to save time.
d) Releasing batches only after complaints are received.
2. Procedures for quality risk management in cGMP include:
a) Avoiding risk assessments as they are time-consuming.
b) Conducting risk assessments to identify, evaluate, and mitigate risks.
c) Implementing CAPA procedures without root cause analysis.
d) Performing risk assessments only for top management decisions.

25. Pharmaceutical Manufacturing and
extemporaneous compounding
•Pharmaceutical manufacturing and
extemporaneous compounding are two distinct
processes involved in the production of
pharmaceutical products, each with its own
characteristics, purposes, and regulatory
considerations.
•Let's explore both processes:

26. Pharmaceutical Manufacturing:
•Pharmaceutical manufacturing refers to the large-scale production of
pharmaceutical products in a controlled and highly regulated
environment. It typically involves the production of standardized
drugs in large quantities for distribution to patients.
•Here are some key aspects of pharmaceutical manufacturing:

27. Regulation
•Pharmaceutical manufacturing is subject to strict regulatory
oversight, with compliance to Current Good Manufacturing Practice
(cGMP) standards being essential.
•Regulatory agencies, such as the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA), establish and
enforce these standards to ensure product quality, safety, and
efficacy.

28. Scale:
•Manufacturing processes are designed for large-scale production,
often involving automated machinery and equipment.
•This allows for the efficient production of consistent and uniform drug
products.

29. Quality Control:
•Robust quality control procedures are in place to monitor and ensure
product quality at every stage of manufacturing.
•Extensive testing, including analytical testing and stability studies, is
conducted to confirm the product's identity, potency, purity, and
safety.

30. Standardization:
•Pharmaceutical manufacturing aims for product standardization and
reproducibility.
•Each batch is expected to meet predefined specifications, and
deviations are carefully investigated and addressed.

31. Formulations
•Pharmaceuticals are produced in various dosage forms, including
tablets, capsules, injections, and more. The formulation and
manufacturing processes are optimized for the specific dosage form.

32. Packaging:
•Products are packaged in appropriate containers and labeled with
essential information, such as dosage instructions, expiration dates,
and batch numbers.

33. Extemporaneous Compounding:
•Extemporaneous compounding, on the other hand, is a process of
preparing customized medications for individual patients when
commercially available drugs are not suitable or available in the
required dosage form, strength, or formulation.
•Here are some key aspects of extemporaneous compounding:

34. Purpose:
•Extemporaneous compounding is performed by pharmacists or
specially trained professionals to meet unique patient needs.
•It is often used for patients with allergies, sensitivities, or specific
dosing requirements that cannot be met with commercial products.

35. Regulation:
•Compounding is subject to regulations established by health
authorities, such as the FDA in the United States.
•Compounding pharmacies must comply with standards outlined in
the United States Pharmacopeia (USP) Chapter <795> and <797> for
non-sterile and sterile compounding, respectively.

36. Customization
•Compounding involves preparing medications in response to a
prescription or a healthcare provider's order.
•The compounding pharmacist customizes the medication's
formulation, strength, and dosage form to meet the patient's specific
needs.

37. Small Scale:
•Compounding is typically carried out on a smaller scale compared to
pharmaceutical manufacturing.
•Each compounded product is prepared individually or in small
batches.

38. Labeling
•Compounded medications are labeled with specific patient
information, directions for use, and the pharmacist's information.
•This labeling is essential to ensure proper administration and tracking.

39. Questions/quiz
1. What is the primary goal of pharmaceutical manufacturing?
a) Customizing medications for individual patients.
b) Producing large quantities of standardized drugs.
c) Preparing compounded formulations.
d) Conducting clinical trials.
2. What is the primary purpose of extemporaneous compounding?
a) Mass production of standardized medications.
b) Customizing medications for individual patients.
c) Conducting clinical trials.
d) Manufacturing over-the-counter drugs.