With a view to sensitise the industry about the intricacies of data integrity and to enable them to handle the process more efficiently, the Goa Pharmaceutical Manufacturers’ Association (GPMA) in association with Indian Pharmaceutical Association (IPA) Goa State branch is organising a one-day event on data integrity on September 8, 2014, in Goa.

Rachel Carmichael, good manufacturing/distribution practice (GMDP) inspector from the UK's MHRA will be giving expert views on the same to help the industry in its transition.

As per the MHRA, from the start of 2014 all the pharmaceutical manufacturers, importers and contract laboratories, as part of their self-inspection programme, must review the effectiveness of their governance systems to ensure data integrity and traceability, in accordance with Chapter 9 of EU GMP.

It is also expected that in addition to having their own governance systems, companies outsourcing activities should verify the adequacy of comparable systems at the contract acceptor. Through this one-day event, the IPA and the GPMA hope to sensitise the pharma companies about the same and highlight them about companies’ ability to demonstrate the integrity and security of laboratory data, records, results and information are prerequisites for any successful inspection of any GMP regulated quality control laboratory.

The event will focus on elucidating the industry members as well as the regulators from India as well as Medicines and Healthcare Products Regulatory Agency (MHRA) on the issues that the industry is facing due to lack of clarity while dealing with data integrity. While simultaneously, experts from the drug regulatory department will help the industry in understanding and getting a clear resolution on this topic.

Salim Veljee, director of the Directorate of Food and Drug Administration Goa who is also the president of IPA, Goa State Branch will also be present at the event along with Suresh Kamath, president of GPMA and associate vice president of Unichem Laboratories and other industry stalwarts.