GOOD LABORATORY PRACTICE

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GOOD LABORATORY PRACTICE AND ISO - 9000

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GOOD LABORATORY PRACTICE AND ISO - 9000: 

GOOD LABORATORY PRACTICE AND ISO - 9000 Presented By: kunal c mehta Dept. of Q.A. I st year M. Pharm Shree Devi College Of Pharmacy..

CONTENTS:: 

2 CONTENTS: What is meant by GLP? Steps in GLP. GLP History and Regulations. OECD Principles. Idea behind GLP. Pillars of GLP. GLP Applications. ISO – 9000.

GOOD LABORATORY PRACTICE: 

3 GOOD LABORATORY PRACTICE Good laboratory practice is a quality system which intends to ensure, thorough, careful and accurate documentation covering all aspects of study and of its environment, the quality, integrity and reliability of safety data. The principles of good laboratory practice have been developed to promote the quality and validity of test data.

IMPORTANT STEPS IN GLP: 

4 IMPORTANT STEPS IN GLP Listen carefully to safety instructions from staff. Make sure u know where fire exit is. Always wear a lab coat. No mouth pipetting. Dispose of chemicals and bacterial cultures in safe manner. Switch of all electrical equipment when u finished the lab.

HISTORY OF GLP AND FIRST REGULATIONS : 

5 HISTORY OF GLP AND FIRST REGULATIONS GLP term is first used officially in” new zealand testing laboratory act”, where development and maintainance of GLP in testing had been made a task. FDA published proposed regulations for GLP in “FEDERAL REGISTER” on november 19, 1976. Register of sep 4, 1987, the FDA amended its GLP regulations with the intent of reducing the regulatory burden on testing facilities.

INTERNATIONAL RIPPLES: OECD PRINCIPLES.: 

6 INTERNATIONAL RIPPLES: OECD PRINCIPLES. The principles of GLP of the OECD were first developed by an expert group which was established in 1978 under special programme on control of chemicals. It states that “data generated in testing of chemicals in an OECD country shall be accepted in other member countries in relation to protection of man and environment”.

IDEA BEHIND GLP: 

7 IDEA BEHIND GLP There are about three issues that are central to ideas behind GLP. They are: Continuation in testing. Accountability. Awareness. GLP is primarily intended to ensure data quality and integrity.

PILLARS OF GLP: 

8 PILLARS OF GLP GLP is based on four pillars which have to support implementation of its principles they are: THE MANAGEMENT THE QUALITY ASSURANCE THE STUDY DIRECTOR THE NATIONAL COMPLIANCE MONITORING AUTHORITY.

WHERE CAN GLP BE PROFITABLY APPLIED: 

9 WHERE CAN GLP BE PROFITABLY APPLIED GLP is found mandatory in safety testing of any items where results are assessed by national regulating authority for purpose of licensing item. GLP applications in laboratories are: Maintaining and calibration of apparatus. Studies should be conducted to the applicable SOPs. All activities should be documented and recorded.

GLP APPLlCATIONS:: 

10 GLP APPLlCATIONS: GLP can be also applied in another ways: It might be used to detect fraud. It could also serve to protect resarcher from unfounded allegations. It can also be applied in recording of data. It can also be applied in resarch environment.

RESPONSIBILITIES IN GLP: 

11 RESPONSIBILITIES IN GLP There are some mutually exclusive tasks where responsibilities have to be fixed in order to create real quality system. they are: Management responsibilities Study director and Principal Investigator Study Personnel Sponsor

MINIMUM SKILLS ANALYST SHOULD POSSESS:: 

12 MINIMUM SKILLS ANALYST SHOULD POSSESS: Knowledge of basic chemical principles and laboratory techniques. Adequate knowledge of CGMP and CGLP. Communication of laboratory results in written reports. Use of instruments like balance, pH meter, melting point apparatus.

QUALITIES OF AN ANALYST: 

13 QUALITIES OF AN ANALYST Possesses aptitude and attitude of mind to become competent analyst. Punctual and disciplined. Well organised and methodological. Pays full attention to details. Possesses experimental skills. Sound knowledge of common compendial procedures. Good presentation and communication skill.

RESPONSIBILITIES OF KEY PERSONNEL IN Q.C. LABORATORY: 

14 RESPONSIBILITIES OF KEY PERSONNEL IN Q.C. LABORATORY Approval or rejection of all raw materials, packaging materials. Evaluation of batch records. Ensuring validation or testing of analysts. Setting up a system of Quality Assurance. Preparing a quality control manual giving all details about systems to be followed.

ISO - 9000: 

15 ISO - 9000 One of the ways of demonstrating quality products is by registering manufacturing facilities for participation in international organisation for standardised 9000 program. The ISO 9000 series consists of five standards , ISO 9000 through ISO 9004, that provide guidelines for quality management and quality assurance. ISO 9000 standards are not so much concerned about methods used in QA, but concerned about how the system works. Cont…

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16 According to oaklynd, defined as quality system as an assembly of components of organisational structure, procedures, processes & resources for implementing quality management Any organisation wanted to compete in international market will have to consider the “ISO 9000” impact. Cont…

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17 The use of reference materials may not be specifically mentioned in ISO 9000 standards, but their use in US certification schemes is mandated. ISO 9000 principles can be used to define quality system under which reference materials are produced, but the standards do not specify the use of reference materials as part of QA practice.

DEFINITIONS IN GLP:: 

18 DEFINITIONS IN GLP: STUDY DIRECTOR: Defined as individual responsible for overall conduct of the non - clinical health and environmental safety study. PRINCIPAL INVESTIGATOR: Defined as individual having responsibility for delegated phases of study to be conducted in accordance with principles of GLP. cont….

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19 TEST FACILITY: It means the premises and operational units that are necessary for conducting non – clinical health and environmental safety study. TEST SITES: Defined as the locations at which a phases of study is conducted. TEST ITEM: It means an article that is the subject of a study. Cont…..

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20 INITIATION DATE: The date on which first study specific data are collected. COMPLETION DATE: The last date on which data are collected from the study. RAW DATA: Defined as all original lab records and documentation which are result of original observations and activities in a study. Cont….

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21 STUDY PLAN: Defined as a document which defines the objectives and experimental design for the conduct of study. DEVIATION: Defined as un intended departure from study plan after study initiation date. AMENDMENT: Defined as intended change to study plan after study initiation date. cont…..

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22 MASTER SCHEDULE: It means an information for assessment of work load and for the tracking of studies at a test facility. REFERENCE ITEM: Defined as any article used to provide a basis for comparison with test item.

REFERENCES:: 

23 REFERENCES: GLP- JURG .P. SEILER – 2nd edition Pg: 1-126 Quantitative analysis of drugs in pharmaceutical formulations – P.D. SETHI -3 rd edition Pg: 23 -35 Quality assurance and TQM for analytical laboratories – PARKARNY – Pg: 187 - 189

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24 Thank you