Hyderabad: GITAM Celebrates ‘cGMP’ Day
GITAM School of Pharmacy (GSP) in Hyderabad proudly celebrated the National ‘current Good Manufacturing Practice’ (cGMP) Day on October 10, 2023. The event was graced by the presence of Dr. C. V. Sathyendranath, Associate Vice President – Corporate Quality at Aurobindo Pharma Ltd, Hyderabad, who served as the chief guest for the occasion.
During the event, Dr. Sathyendranath delivered a lecture on the importance of ‘Good Documentation Practice’ (GDocP), which is an integral part of quality assurance and is linked to all aspects of Good Manufacturing Practice (GMP). He emphasized that GDocP is a systematic procedure involving the preparation, reviewing, approving, issuing, recording, storing, and archival of documents.
Explaining the significance of Good Manufacturing Practices, Dr. Sathyendranath stated, “GMP ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.” He further highlighted that Good Documentation Practices are essential to protect the integrity and quality of all documents, both electronic and handwritten, used in various GMP operations and activities. These practices ensure that records are truthful, readily retrievable, and traceable.
Dr. Sathyendranath stressed the importance of keeping personnel updated on the application of GDP. He emphasized the need for understanding and applying the principles of ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) and ALCOA-plus to electronic data in the same manner as traditional paper records.
During his lecture, Dr. Sathyendranath also highlighted key points of GMP, including Quality Management, Personnel Qualification and Hygiene, Building and Facilities, Process Equipment, Documentation and Records, Materials Management, Production and In-process Controls, Packaging and identification labels of API and Intermediates, Storage and Distribution, Laboratory Controls, Validation, Change Control, Rejection and Re-use of Material, Complaints and Recalls, Contract Manufacturers, Cell Culture/Fermentation, and Clinical Trials, among others.
The event commenced with a warm welcome extended by Prof. G.S. Kumar, Principal of GSP, who also felicitated Dr. Sathyendranath. Dr. Hyma Ponnaganti, Assistant Professor and Coordinator of the program, proposed the vote of thanks.