Role of Quality Assurance Team in Good Laboratory Practices

Equipment and Working Materials Validation 01 02 'faulty' instruments may appear to give valid data calibration frequency, re-validation, & testing serviced and calibrated at suitable intervals maintain readily available records reflect next calibration date traceable to national/international standard adjust equipment based on comparison to ______

Adjust balance after comparison to certified ______

Necessary for analytical laboratory Written Operating Instruction Equipment & Manufacturer's Name Model type & Serial No. Date equipment received Manufacturer's instructions Note: Withdraw Defective instrument (avoid use) Reagents Should be dated upon receipt or preparation and labeled for identification Reagents made up in the laboratory should be prepared by competent ______ (as per SOP) Reagent Labels Concentration Standardization factor Shelf life and storage conditions Preparation Date Re-standardization Date Signature of ______ who prepared the reagent Note: Reference standards must be dated & properly stored; Refer...

Reagents made up in the laboratory should be prepared by competent ______ (as per SOP)

Reagent Labels Concentration Standardization factor Shelf life and storage conditions Preparation Date Re-standardization Date Signature of ______ who prepared the reagent

Reference ______ must be dated & properly stored; Refer...

Good Laboratory Practices are a quality system related with the organizational process and the conditions under which laboratory activities are: Planned, Performed, Monitored, Recorded, and ______

Simple GLP rules include: Say What You Do (with written SOP), Do what you say (follow procedures), Be able to prove it (with good record keeping). These rules aim to allow better laboratory management, improve efficiency, minimize occurrence of ______

GLP Components in the Quality Manual include Organization and Personnel, Analytical or testing systems, Facilities, Equipment and Working materials, Quality control, Reporting and filing of results, Education & Experience including additional trainings (documented), Satisfactory Training & Competence established for each analyst, Analyst Certification, Sufficient People, Efficient & Effective, Varied Certification Requirements customer/regulatory. The Organization and Personnel section ensures that the organization chart reflects realities (up to date), there are sufficient people, and Responsibilities of all personnel are clearly defined (Job Description). Facilities section ensures laboratory layout avoids overcrowding, cross contamination, ______ between projects, and cramped working conditions. Storage areas should be available for supplies and equipment & the provision of adequate protection against infestation, contamination, and deterioration. Storage areas should be separate to allow better laboratory, improve efficiency, minimize occurrence of accidents, improve safety, and allow quality control. Facilities should include important areas like Sample Receiving, Sample Storage, Sample Processing, Staining, Waste Disposal, Media Preparation and Glassware Washing, Isolation Room, Sterilization, Lounge, etc.

The FDA conducted an in-depth investigation on 40 toxicology laboratories in pharmaceutical companies and discovered a lot of fraudulent activities and poor laboratory practices. This led to the introduction of GLP rules including: Say What You Do (with written SOP), Do what you say (follow procedures), Be able to prove it (with good record keeping). These rules aim to allow better laboratory management, improve efficiency, minimize occurrence of mistakes, improve safety, allow quality control, and stimulate and motivate all personnel. The GLP Components in the Quality Manual ensure Organization and Personnel, Analytical or testing systems, Facilities, Equipment and Working materials, Quality control, Reporting and filing of results, Education & Experience including additional trainings (documented), Satisfactory Training & Competence established for each analyst, Analyst Certification, Sufficient People, Efficient & Effective, Varied Certification Requirements customer/regulatory. The Organization and Personnel section ensures that the organization chart reflects realities (up to date), there are sufficient people, and Responsibilities of all personnel are clearly defined (Job Description). Facilities section ensures laboratory layout avoids overcrowding, cross contamination, ______ between projects, and cramped working conditions.

The FDA was already aware of poor laboratory practices all over the US, leading to an investigation on 40 toxicology laboratories in pharmaceutical companies. The result was the discovery of a lot of fraudulent activities and poor laboratory practices. Simple GLP rules were introduced including: Say What You Do (with written SOP), Do what you say (follow procedures), Be able to prove it (with good record keeping). These rules aim to allow better laboratory management, improve efficiency, minimize occurrence of mistakes, improve safety, allow quality control, and stimulate and motivate all personnel. The GLP Components in the Quality Manual ensure Organization and Personnel, Analytical or testing systems, Facilities, Equipment and Working materials, Quality control, Reporting and filing of results, Education & Experience including additional trainings (documented), Satisfactory Training & Competence established for each analyst, Analyst Certification, Sufficient People, Efficient & Effective, Varied Certification Requirements customer/regulatory. The Organization and Personnel section ensures that the organization chart reflects realities (up to date), there are sufficient people, and Responsibilities of all personnel are clearly defined (Job Description). Facilities section ensures laboratory layout avoids overcrowding, ______ contamination, confusion between projects, and cramped working conditions.

The FDA introduced GLP principles in the US in the year 1978. Non-US companies had to comply with US GLP regulations and register their pharmacies. The Organisation for Economic Co-operation and Development (OECD) produced GLP Principles that became an international standard in 1981. The benefits of adhering to GLP rules include better laboratory management, improved efficiency, minimized occurrence of mistakes, improved safety, quality control, and stimulation and motivation of all personnel. The GLP Components in the Quality Manual cover Organization and Personnel, Analytical or testing systems, Facilities, Equipment and Working materials, Quality control, Reporting and filing of results, Education & Experience including additional trainings (documented), Satisfactory Training & Competence established for each analyst, Analyst Certification, Sufficient People, Efficient & Effective, Varied Certification Requirements customer/regulatory. The Organization and Personnel section ensures that the organization chart reflects realities (up to date), there are sufficient people, and Responsibilities of all personnel are clearly defined (Job Description). Facilities section ensures laboratory layout avoids ______ contamination, confusion between projects, and cramped working conditions.