University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.
The 7 Deadly Sins of Quality Assurance and Quality Control - Pharma IQ eBookPharma IQ
The Seven Sins of QA and QC are those transgressions which are detrimental to quality and profitability. You will probably commit some of them every day. We asked the global pharmaceutical community what they thought were the biggest sins that people commit in quality assurance and quality control and the same ones kept coming up over and over again.
The SlideShare 101 is a quick start guide if you want to walk through the main features that the platform offers. This will keep getting updated as new features are launched.
The SlideShare 101 replaces the earlier "SlideShare Quick Tour".
The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms.
The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
This presentation is all about those days that still comes at eyes with a memorable story. This is just the explanation from my perspective. I hope that this belongs to my personal description and present my view to situation.
2. > “Good Laboratory practice” introduced in 1970s
>Is a frame work for lab. Studies
>Generate safety data
>Applied on non-clinical studies
>Safety to human/environment
>Studies are submitted to NRA
(National Registration Authority).
3.
4. RESEARCH CLINICAL
NON-CLINICAL POST APPROVAL
&
DESCOVERY
STUDY BASED PROCESS BASED
Time line approximately 12yrs.
5. >Rsources: Human, Facilities, calibrated equipments
>Characterizations: Study characters of materials
>Rules: Protocols/study plans, written procedures
>Results: Raw data, study reports, Achieves
>Quality Assurance: acts as ‘WITNESS’ in research
>Responsibilities: for sponsor management
>Adequate lab. Space: avoid cross-contaminations
6.
7. >Quality Assurance
>Fraud
>Reproductivity
>GLP is a regulation
>Traceries and integrate the data
>Defines & stand arise: planning, performance,
reporting, recordings, monitoring, archives.
>Avoidance of repeated testing.