Role of GMP, quality assurance, validationpptx

advanced pharmaceutics

1. Role of GMP, Quality Assurance and Validation

2. Role of GMP, Quality Assurance and Validation Assignment of ADVANCED PHARMACEUTICS PHS C C 2201 Session 20 23-2024 Department of Pharmaceutical Sciences Dr. Harisingh Gour Vishwavidyalaya, Sagar, (M.P.) (A Central University) Supervisors: DR. DHARMENDRA JAIN DR. PRIYANKA JAIN DR. UDITA AGRAWAL Submitted by: ADARSH SHARMA Y 23254001

3. Table of contents Introduction 01 Quality Assurance 03 About GMP 02 Validation 04 Types Scope Roles Components Definitions About Advantages

4. 1. What is gmp?

5. Build the quality system Structure the Organization Establish policies, objectives, plans Review the system Provide leadership Teamwork and Risk management Role and responsibilities:

6. The 5p’s of gmp Products Clear specifications at every phase of production Processes Properly documented, simple and consistent People Comprehend roles and responsibility Procedures Guidelines for undertakings critical processes Premises Cleanliness and equipment calibration always

7. Components of GMP Material management Quality control Equipments Quality management Personnel Surroundings, buildings and facilities Aspects of management function that implies quality policy Quality of medicines depends on quality of people who produce them Well sanitation system Premises cleaned, disinfected Protection from pests Electrical supply, temperature, humidity, ventilation appropriate Cleaned and calibrated Logbook maintained with name, use, operators using it Raw materials, finished product, packaging material Quality, safety, efficacy Complaints Samples rechecked CAPA- corrective and preventive action taken Record maintained Part of GMP: Sampling Specifications Testing Documentation Health and hygiene Cleanliness Proper dressing Gloves Masks No smoking Standard operating procedure (SOP)

8. 2. What is quality assurance? Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.  It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. QA is the heart and soul of quality control QA = QC + GMP /Other Quality Systems. QUALITY CONTROL QC is part of GMP concerned with sampling, testing, documentation and release procedures which ensures that necessary and relevant tests are carried out. How quality assurance differs from quality control???

9. Quality Assurance Quality Control Definitions Set of activities for ensuring  Quality in the Processes  by which products are developed. Set of activities for ensuring quality in the Products. The activities focus on  identifying defects  within the actual products produced. Goal To improve  development and test processes  so that defects do not arise when the product is being developed. To identify defects after a product is developed and before it’s released. Focus on QA’s goal is to  prevent defects  with a focus on the  processes  used to make the product. Proactive quality process. QC’s goal is  to identify and correct defects  in the  final product . Reactive process . How To build a good  quality management system. Finding and eliminating sources of quality defects/issues What Prevention of quality problems  through planned and systematic activities including documentation. The  activities or techniques used to achieve  and maintain the product quality, process, and service. As a Tools QA  is a managerial tool, QC is a corrective tool.

10. Operations performed by Quality assurance:  Checking and inspections of physical parameters of incoming raw material and packing material.  Checking of proper labeling and status tags on each container during all drug manufacturing process. In-process testing and periodic rechecking and recording the results  Issuance of line clearance tag at every batch change over.   Dispensing of starting material and monitoring of manufacturing procedure according to master formulation. Handling of customer complaint and batch recall. Area monitoring such as temperature and humidity control record. Process validation of production department.

11. Advantages Quality assurance:

12. 3. What is Validation ?

13. Types of validation: 1. Process validation Prospective validation Concurrent validation Retrospective validation Re-validation 2. Cleaning validation 3. Validation of analytical methods

14. Evaluate individual risk Potential cause Prospective validation: This type of validation is performed before production, during a product’s development stage.  A risk analysis is performed to assess the production process by breaking it down into separate steps. These are individually evaluated and based on experience, the likelihood of each one leading to critical situations is determined. Once you’ve identified the critical sub-processes, these are the steps you should follow: Investigate and assess Probability solution

15. c) Retrospective validation: You should monitor the first three batches produced on a production-scale as closely as possible.   The data gathered through this step can provide an in-depth insight of the fundamentals, which greatly impacts the effectiveness of concurrent validation.  Together with comprehensive trend analysis, which includes other aspects like stability, you should perform concurrent validation throughout a product’s life to whatever extent it is needed. b) Concurrent validation: As the name suggests, retrospective validation is rather like validation in hindsight. It involves examining the past experiences of the process and evaluating the final control tests. This evaluation is done while assuming that the procedures, composition and equipment remains unchanged. To determine how well the process parameters adhere to the permissible range, you can also conduct a trend analysis. Retrospective validation should not be considered a quality assurance measure, rather it should be performed only in certain circumstances, like when you’re introducing validation requirements for the first time. It is more useful for establishing priorities for validation, so avoid this technique for new products or processes.

16. Quantify additional components   Method simplification or improvement  Complexity of the method  Safety concern Economic consideration  Sample throughout  Changes in manufacturing process  FDA guidelines/requirements d) RE-VALIDATION: as the method under validation is required to be written, any methods require re-validation:

17. 3) Method validation: This is establishing documented evidence that a cleaning procedure consistently results in equipment cleaned to a predetermined acceptable level. Cleaning validation should consider residual active substances, detergent residues, hard to clean excipients and areas of equipment which are known to be difficult to clean with respect to the potential risk of cross-contamination of other products. Cleaning validation must be conducted according to an approved protocol which specifies the procedures and tests to be conducted and the data to be collected as well as the acceptance criteria to be applied. 2) Cleaning validation: All analyses performed for validation should be conducted in accordance with validated analytical methods. The general principle applied will be that the final validation of methods should be carried out in the Laboratory and by the personnel which will be routinely using them.

18. Analytical test methods Accuracy, precision, specificity, limit of detection, linearity etc.. Instruments calibration Temp., Weight, pH, Humidity Process utility services Water, steam, HVAC system Raw materials & Packaging materials Specification, vendor certificate  Equipment Equipment qualification programme start with Users Requirement Specifications & Functional Requirement Specifications these two requirements will result i n to the Design Qualification Scope of validation:

19. REFERENCES: Jain N.K, “Pharmaceutical Product Development”, CBS Publishers & Distributors, 2 nd edition,2010, Pg.no. 1-30, 335-367 Sharma , A., Gamta , V. and Luthra , G. (2023) “The Importance of Good Manufacturing Practices (GMP) in the Healthcare Industry”,  Journal of Pharmaceutical Research International , 35(18), pp. 75–90 Sharma A, Luthra G. Role of regulatory affairs in a Medical Device industry. Current Journal of Applied Science and Technology. 2022;1–7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2016. ICH Q7 guideline: Good manufacturing practice guide for active pharmaceutical ingredients.