Good laboratory practices in a pharmaceutical lab 1

GLP, QA, QC implementation in pharmaceutical lab

1. Good Laboratory Practices in a Pharmaceutical Lab BS.BCH 7 TH (M) Group 6

2. MEMBERS: ASMAA RIAZ 16-ARID-2539 AYESHA KANWAL 16-ARID-2541 EJAZ UL HAQ 16-ARID-2543 FAIZA WAHID 16-ARID-2546 LARAIB AMJAD 16-ARID-2554 RASHID IQBAL 16-ARID-2565 SABAHAT ALI 16-ARID-2569 TANZEELA NOUREEN 16-ARID-2578

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.

9. Stepwise GLP Implementation:

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: Effectiveness extent to which planned activities are realized &planned results achieved. Efficiency relationship b/w results achieved & resources used. 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: 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

29. REFERENCES: https://www.pharmaguideline.com/2011/08/good-laboratories-practice-glp.html https://www.pharmaguideline.com/2016/05/6-ways-to-reduce-human-errors-in-pharmaceuticals.html https://tipt.com/blog/why-quality-assurance-training-is-so-important-in-the-pharmaceutical-industry/ https://www.labcompare.com/Pharmaceutical-Lab-Equipment