The PharmExcil event organized by Indian Pharmaceutical Association (IPA) at Hotel Sayaji, Indore, on November 7, 2014, was themed around “USFDA – Steps for Sustained Compliance”. Various office bearers of IPA, FDA, PharmExcil and senior executives from pharmaceutical industry attended the event to collaborate, discuss and share their experiences of current GMP requirements, FDA’s concerns on drug quality and data integrity issues.
It was a very important event because of the fact that many branded drugs in the last few years have completed 20 years and will be available for manufacturing and selling as generic drugs. India is the second-biggest generic drug manufacturer and supplier to the USA, after China. For India, if they have to sustain their position, they have to manufacture drugs as per FDA requirements more than ever. In this regard, BatchMaster Software Pvt. Ltd. who has timely introduced pharmaceutical specific, out of the box complete software solution also participated and contributed to the event.
The event started by taking an oath for quality. Leaders from different well-known pharma companies, namely: Wyeth, Cipla, Lupin, Ranbaxy, AstraZeneca, and many more infused intelligent speeches. There were speeches by renowned authorities on different topics that could help manufacturers meet and maintain stringent regulatory compliance. It included investigation skills, creating and implementing a sustainable quality culture, learning from past FDA letters, CAPA tracking, recent GMP changes, issues related to drug quality and data integrity.
Following the lectures from elite speakers, there was an open house Q&A session in which other participants also shared their experience and asked questions to the panel. Q&A session and interaction that followed revolved around the following points. They are:
- The impact of delays in generic drug approval by FDA. Current information expectations of FDA from new ANDA application to reduce the approval time.
- How and what kind of steps or manufacturing information should be maintained to reduce FDA’s concerns on data integrity and drug quality.
- Current requirements of CFR part 11 compliance and differences between part 11 with Annex 11 introduced in Europe.
- Discussion on recent changes incorporated in “Process validation” by FDA, specifically scope of risk-based product and process understanding for validating any process.
In the event, BatchMaster Software showcased its ERP Software for Pharma Industry, designed specifically for the pharmaceutical industry. This software solution helps pharmaceutical manufacturers not only to make cost-effective pharmaceutical products but also has many features- required for compliance with current GMP regulatory requirements. BME ERP B1 software solution rests on the sound foundation of SAP B1 with advanced process manufacturing capabilities contributed by BatchMaster software. To the surprise to many participants, this software already has many features whose need was felt and discussed during the conference.
Following are some features of BatchMaster ERP for pharmaceutical industry drew attention and appreciation of the participants.
- Electronic BMR
- Quality Inspection Plans for keeping monitoring information of the batch.
- Electronic execution of SOPs by Inspection checklist
- CFR part 11 compliance
- Electronic Batch ticket
- Electronic weigh sheet
- Non-conformance and CAPA.
- Adverse event reporting
- Production and scheduling planning (MPS/MRP)
Everyone who attended the conference found event as a great success with a lot of new information coming from established and well-experienced leaders from the different facet of pharmaceutical segments. Many participants were satisfied that their doubts on regulatory expectations were clarified and appropriately answered.
Thanks to IPA for organizing this event. Every interaction was a moment of fact and a moment that matters.