good laboratory practices.pptx

Please review the material to gain a better understanding of the basics of Good Laboratory Practices.

1. Good Laboratory Practices Shruti Patil Bachelor of pharmacy

2. good laboratory practices In the experimental research area, Good Manufacturing Practice or GLP refers to a quality system. It ensures uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests. GLP was first introduced in New Zealand and Denmark in 1972 and In the US in 1978, due to the industrial Bio-Test Labs scandal. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals to man, animals, and the environment. ,

3. Good Laboratory Practice embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported, and archived. These studies were undertaken to generate data by which the hazards and risks to users, consumers, and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives, and contaminants, novel food, biocides, detergents, etc….. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risks/safety assessments. GLP is a data quality system so should not be confused with standards for laboratory safety-appropriate

4. The US FDA In the US FDA has rules for GLP in 21CFR58 . Preclinical trials on animals in the United States of America use their rules before clinical research on humans. Research in the US not conducted under these restrictions or research done outside the US not conducted according to the OECD Guidelines might be inadmissible in support of a New Drug Application in the US.

5. OECD guidelines for the testing of chemicals They were first published in 1981, and they are split into five sections : Section 1: Physical-chemical Properties Section 2: Effects on the Biotic System Section 3: Degradation and Accumulation Section 4: Health Effects Section 5: Other Test Guidelines Guidelines are numbered with three-digit numbers Section number is the first number Sometimes guidelines are suffixed with a letter.

6. ISO 9000 The ISO 9000 (International Organization for Standardization 9000) family of quality management system standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. The ISO 9000 deals with the fundamentals of the quality management system ISO 9001 deals with the requirements that organizations wishing to meet the standards must fulfil.

7. ISO 9000 is headquartered in Geneva, Switzerland . Over one million organizations worldwide are independently certified to meet the requirement of ISO 9001 ISO 9000 was first published in 9187 and based on the BS 5750 series of standards from BSI (British Standards Institution)

8. Iso 9000 series quality management principles ISO 9000 series based on eight quality management principles The eight quality management principles are defined in ISO 9000:200 Quality Management System- Fundamental and Vocabulary ISO 9004:2009 , Managing for the sustained success of an organization- a quality management approach

9. Principle 1 customer focus: Organizations depend on their customers and therefore should understand current and future customers’ needs Principle 2 Leadership: leaders establish the unity of purpose and direction of the organization Principle 3 Involvement of people: People of all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit Principle 4 Process approach: The desired results are achieved more efficiently when activities and related resources are managed as a process. Principle 5 System approach to management: Identifying, understanding, and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives Principle 6 Continual improvement: continual improvement of the organization’s overall performance should be a permanent objective

10. Principle 7 Factual approach to decision-making Principle 8 Mutually beneficial supplier relationships: an organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

11. TQM Total quality management It is consists of organization It need wide effects to install and make permanent a climate in which an organizations continuously improves its ability to deliver high TQM efforts typically draw heavily on the previously develop tools and techniques of quality control

12. Quality review and quality documentation Regulatory control contain three regulatory classes The regulatory control for each device class include: General control(low to moderate risk) General control and special control(moderate to high risk) General control and premarket approval(high risk)

13. 2. General controls general control is described in the following sections of the FD &C Act 501: Adulterated device 502: Misbranded device 510: Registration of producer of device - establishment and registration and device listing - premarket notification - reprocessed single 516: Banned devices 518: Notification and other remedies - notifications - repair - replacement - refund - reimbursement - mandatory recall 519: Records and report device - adverse event report

14. Pharmaceutical analysis device tracking unique device identification system Reports of removal and corrections 520: general provisions respecting the control of devices intended for human use custom device Restricted device Good manufacturing practice requirement Exemptions for devices for investigational use Transitional provisions for devices considered as new drugs Humanitarian device exemption

15. Special controls Special controls required for class 2 devices performance standards postmarked surveillance Patient registries Special labeling requirements Premarket data requirement Guidelines

16. Premarket approval Under federal law class 3 devices are subject to the approval of premarket approval application (PMA)devices Device that are not within a type marketed before the date of the Medical Device Amendments of 1976 referred to preamendments devices Class 3 are automatically comes under federal law The FDA classified into class 3 devices intended to used in supporting or sustaining human life or preventing impairment of human health

17. validations For medical device, food, blood products, biological product , tissue , establishment, clinical trials conducting institutions we use the validation Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. Validation required of food and drug, pharmaceutical regulating agencies like FDA’s good manufacturing practices guidelines Subsections used in the validation: Equipment validation Facilities validation HVAC system validation Cleaning validation Process validation Analytical validation Computer system validation Packaging validation

18. The validation process The validation scope , boundaries and responsibilities for each process or group of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and reference for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment(VRA) to ensure that the scope of validation being authorized is appropriate for the complexity and importance of the equipment or process under validation The reference is that may affect the efficacy, quality and or records of the product are properly qualified.

19. Qualification includes the following steps: Design qualification(DQ)- demonstrates that the proposed design will satisfy all the requirements that are defined and defined and detailed in the User Requirement Specification(URS) satisfactory execution of the DQ is a mandatory requirement before construction of the new design can be authorized. Installation qualification(IQ)- demonstrate that the process or equipment meets all specification, is installed correctly, and all requirement components and documentation needed for continued operation are installed and in place. Operational qualification(OQ)- demonstrates that all facets of the process or equipment are operating correctly. Performance qualification(PQ)- demonstrate that the process or equipment performs as intended in a consistent manner over time Component qualification(CQ)- is a relatively new term developed in 2005. this term refers to the manufacturing of auxiliary components to ensure that they are manufactured t the correct design criteria. This could include packaging components must have some type of random inspection to ensure that the third party manufacturer’s process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

20. Processed validation Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standards. Regulatory authorities like EMA and FDA have published the guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs Process validations an ongoing process that must be frequently adapted as manufacturing feedback is gathered . End to end validation of process is essential in determining product quality because quality cannot always be determined by finished product inspection Process validation can be broken down into 3 steps: process design , process qualification , and continued process verifications

21. Validation of equipment Validation first developed for equipment and process. In 1993 the software for a large-radiotherapy device was not designed and tested properly. Several problems resulted in several devices giving doses of radiation higher than intended So many patients died and several got permanently injured that is why validation of equipment is required for pharma Industry following are the steps followed to do validation of equipment in SAP and how create link between maintenance Order and calibration order .