Role of c in cGMP

Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Role of c in cGMP

Joint Event on 6th International Conference and Exhibition on GMP, GCP & Quality Control & 7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

September 25-26, 2017 Chicago, USA

Abha Doshi

MET Institute of Pharmacy, India

Posters & Accepted Abstracts: Pharm Regul Aff

Abstract :

GMP should be updated time to time to comply with the standard guidelines. The good manufacturing practices which were considered 10 years ago are not relevant today. Time and process have changed. Industry should upgrade the GMP level in current context. cGMP, where â??câ?? stands for current, reminds manufacturers that they must employ technologies and systems which are up-to date to comply with the regulation. Any company employs cGMP indicates that they are following 21 CFR 210 and 211 and no other. The facilities in manufacturing area are to be upgraded time to time. For parenteral manufacturing facilities, the emphasis is given on better environment control, which gets easier by adopting latest technologies. The inclusion of latest instruments and systems for in-process quality control helps in achieving high yield, minimum wastage with the best quality. As per the current guidelines, there should be a proper procedure for backup, restoration and archival of the electronic data inside the instruments. The role of â??câ? starts from the planning to manufacturing to testing to marketing and beyond that.

Google Scholar citation report
Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

Pharmaceutical Regulatory Affairs: Open Access peer review process verified at publons

Indexed In

arrow_upward arrow_upward