GOOD LABORATORY PRACTICES IN PHARMACEUTICAL INDUSTRY

Industrial Pharmacy II , B. Pharm VII Sem student.

Good Laboratory Practices (GLP) is a set of standards and principles ensuring the quality, reliability, and integrity of laboratory studies used in research and regulatory decision-making. This presentation covers the core principles, objectives, organizational structure, and practical implementation of GLP in pharmaceutical laboratories, highlighting its role in ensuring accurate study results, regulatory compliance, and global acceptance while addressing common challenges faced during implementation.

1. Submitted By:- Harshita J. Kirpane Trupti S. Tagade B. Pharm 4 th year B.K.C.P Sakoli BAJIRAOJI KARANJEKAR COLLEGE OF PHARMACY (BKCP), SAKOLI , 441802 RASHTRASANT TUKADOJI MAHARAJ UNIVERSITY NAGPUR , M.S. INDIA Harshita J. Kirpane, Trupti S. Tagade Subject: Industrial Pharmacy II, B Pharm Final Year Guide Name: Chandrashekhar M. Chakole GOOD LABORATORY PRACTICES

2. Contents Introduction Purpose Objectives Organization Principles Advantages Disadvantages

3. Introduction In 1970s , the concept of “ Good Laboratory Practices” developed in USA , due to concern about the validity of nonclinical safety data submitted towards the Food and Drug Administration ( FDA ) in the context of latest New Drug Administration ( NDA ) . DEFINATION :- Good Laboratory Practices ( GLP ) is a set of rules and principles that give a proper system for how laboratory studies Should be planned , performed , checked , stored and reported . It is simply means doing work in the laboratory in a good and proper way .

4. Purpose of Good laboratory Practices ( GLP )

5. Objectives of GLP To ensure quality and reliability. To maintain Uniformity. To promote safety. To build trust in the test results for use by regulatory authority , industries and the public . To Facilitate international acceptance. To ensure proper documentation . To support regulatory decisions . To minimize errors in laboratory testing .

6. Organisation of Good Laboratory Practices ( GLP ) Organisation is a part of planning process. It is an important tool for getting work done from human being . In context with the quality, Organisation consist of :- Identification of quality activities . Assigning responsibility for performing identified quality activities. Defining the authority and responsibility associated with each job with other jobs . Dividing the total work pile into logical parcels of work , known as Jobs .

7. MANAGEMENT Head sales Head quality control Head production Quality assurance unit In process control unit Inspection and test unit Fig : simplest organization of Good Laboratory Practice

8. Principles of Good laboratory Practices ( GLP ) Test facilities organisation and personal . Quality Assurance Programme ( QAP ). Facilities . Apparatus , material and reagents. Test system . Test and reference substances . Standard operating Procedures ( SOP ) . Storage and retention of records and materials.

9. 1.Test facility organization and personnel . The test facility must have a proper management structure with clear roles and responsibilities . There should be an independent Quality Assurance ( QA ) Unit that checks whether studies are performed according to GLP . In responsibilities of personnel all staff must be properly trained for their tasks. They should follow SOPs and safety rules. Personnel must report any problems or deviations immediately .

10. 2. Quality assurance program The quality assurance program is an independent system within in a test facility that ensures every study is conducted according to GLP principles . . The main function of QA in GLP, QA unit is separate from study personnel to avoid bias. . The QA inspects critical phases of studies . . The purpose of QA program in GLP to provide assurance that studies are planned , preformed , monitored and reported in compliance with GLP .

11. 3. Facilities The test facility is the physical place where GLP studies are conducted . The proper facilities are essential to ensure accuracy , avoid contamination and maintain integrity of studies . The key requirements of facilities under GLP is the layout should support smooth workflow . Enough space to avoid mix-up of test items , samples or animals . There should be separate areas for different activities like animal housing , storage rooms , archives for raw data and specimens .

12. 4. Apparatus , materials and reagents All instruments like – weighing balances , spectrophotometers , chromatographs , animal cages , etc. Apparatus properly maintained to avoid malfunction . Materials includes glassware , plasticware , cages , filters and other laboratory supplies must be clean and contamination free , stored properly and labelled clearly . Reagents must be known purity and quality . Containers must labeled with name , concentration , preparation date , expiry date and storage conditions .

13. 5. Test systems In GLP the test system is the biological , chemical or physical system that is used to obtained data in a non clinical safety study . Proper handling in test system ensures that the study results are reliable, reproducible and scientifically valid . The test system factors such as – species , strain , age , sex , health and environmental conditions must be considered . Each test system must be uniquely identified .

14. 6. Test and reference substances The test substance is the chemical , drug , pesticides , cosmetic material or other material whose safety or properties are being studied . Identity , purity , stability , solubility and physicochemical properties of test substances should be known . The reference substance is used for comparison or validation in a study . Reference data should help verify whether the test system and conditions are working properly .

15. 7. Standard operating procedure (SOP) In Good laboratory Practices (GLP) , standard operating procedures (SOPs) are written , approved instructions that described how to perform specific routine operations in a consistent and reliable way . Purpose of SOPs - To ensure that all personnel follow the same standardized methods . To maintained reproducibility of study results . To avoid errors caused by differences in technique . Responsibilities – managements , quality assurance , study directors .

16. 8. Storage and retention of record and materials In Good Laboratory Practices (GLP) , proper storage and retention of study related material and record ensures that data can be verified , reconstructed, and inspected at any time in the future . Purpose – To ensure all raw data , documents, sample , and specimens are securely stored . To protect against loss, damage, or unauthorized access. To make sure records are readily retrievable for inspections or regulatory review .

17. Advantages of Good Laboratory Practices(GLP) It ensures test results are accurate , consistent and trustworthy . It gives guarantee that drugs , chemicals and products tested are safe for human , animals or environmental use . It meets national and international standards (FDA, OECD, CDSCO, etc.) helping in product approval. Data generated under GLP is recognized globally, reducing the need for duplicate testing. GLP improves staff skills and encourages responsibility and discipline in the workplace.

18. Disadvantages of Good Laboratory Practices (GLP) Implementation requires trained staff, equipment validation, documentation and audits, which can be expensive. Researchers must strictly follows protocols, leaving little room for creativity or changes during experiments. Continuous training of staff is necessary, which adds to workload and cost. Small laboratories or industries may find it difficulty to comply with GLP guidelines. Needs proper infrastructure, storage, equipment calibration, and maintenance, which may not be feasible for all labs.

19. Conclusion Good Laboratory Practices (GLP) is a set of principles that ensures quality, safety, reliability ,and integrity in laboratory studies. It promotes standardization, proper documentation, trained personnel, and regulatory compliance, which together safeguard human health, the environment, and product quality.

20. eferences :- The book of quality assurance manual by Shah. H. D. Business Horizons pharmaceutical publisher. https ://en.wikipedia.org/wiki/Good_laboratory_practice

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