The Bengal branch of the Indian Pharmaceutical Association conducted a national level workshop on the subject, “Ensuring Data Integrity, Need of the hour in Pharma Industry”, last week. IPA's initiative was in the context of increasing number of notices and alerts the pharma companies are receiving in the state from the regulatory authorities.
The programme was supported by the Regulatory Affairs Division of the IPA and was attended by sixty executives from various pharma companies.
While inaugurating workshop, the director of drugs control in West Bengal, Dr. Chidanata Mani Ghosh, said the technical persons in the pharma industry require continuous upgradation of knowledge to cope up with regular change of regulatory requirements.
Dr. P.L.Sahu, principal scientific officer & head - R&D, Indian Pharmacopoeia Commission (IPC) spoke on the topic ‘Data Integrity: Quality Control’(DIQC) perspective. He explained the concept of data integrity, how data should be supported by Meta Data and how it could be traced from data trail. He also discussed with examples of data generated by several instruments like HPLC.
Sankar Gupta, former Deputy Drugs Controller, government of India, spoke on Data Integrity: manufacturing operations perspective etc. He explained with examples of several manufacturing operations.
Tridib Neogy from the company Albert David Limited spoke on Data Integrity in relation with Schedule L1 (GLP). Neogy explained the requirements of data integrity as per sec. 15 of Schedule L1 of the Drugs and Cosmetics Rules. He nicely explained the methodology step by step to maintain data integrity in implementing good laboratory practice.
Prof (Dr) Jayanta Chattopadhyay, Bengal School of Technology and former vice president of Fresenius Kabi Oncology Ltd spoke on the topic "Implication of Data Integrity: case studies”. He said data integrity has been made mandatory by several regulatory authorities like-US FDA, MHRA etc.
The programme was initiated by a welcome address by Dr. Subhash C. Mandal, president, IPA Bengal branch. In his welcome speech, Dr. Mandal said as part of the continuous education programme, this important issue was selected to train the industry personnel and several industrial units have received notices, alert, sanction etc. from several regulatory authorities.