A guest lecture on “Computer System Validation and 21 CFR part 11” was arranged by Department of Pharmaceutics on 25th November 2015. The guest speaker was Mr. Devaraj Shetty, DGM – Quality, Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre.
Abstract: To ensure that the products manufactured by the industries such as pharmaceutical, biotech and medical devices, meet specific requirements for identity, strength, quality, and purity FDA mandates Current Good Manufacturing Practices (cGMP).
In order to comply with cGMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.
21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated. 21 CFR Part 11 also specifies a number of requirements for software systems to enable trustworthy and reliable electronic records and signatures
Hence it becomes important for students to have a fair amount of exposure and be fairly aware of these quality directives even before they moved into the corporate environs.
The Vice Principal, Dr. R. Narayana Charyulu welcomed Mr. Devaraj Shetty and commended the achievement of the speaker in the field of pharmaceutical validations to faculty members, Research Scholars, PG and UG students gathered. Mr. Shetty was presented a memento as a token of appreciation and the program ended with vote of thanks.
Abstract: To ensure that the products manufactured by the industries such as pharmaceutical, biotech and medical devices, meet specific requirements for identity, strength, quality, and purity FDA mandates Current Good Manufacturing Practices (cGMP).
In order to comply with cGMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.
21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated. 21 CFR Part 11 also specifies a number of requirements for software systems to enable trustworthy and reliable electronic records and signatures
Hence it becomes important for students to have a fair amount of exposure and be fairly aware of these quality directives even before they moved into the corporate environs.
The Vice Principal, Dr. R. Narayana Charyulu welcomed Mr. Devaraj Shetty and commended the achievement of the speaker in the field of pharmaceutical validations to faculty members, Research Scholars, PG and UG students gathered. Mr. Shetty was presented a memento as a token of appreciation and the program ended with vote of thanks.
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