More than 150 participants from different pharma companies participated
Usha Sharma – Mumbai
Indian Drug Manufacturers’ Association (IDMA) recently organised a day-long workshop on ‘Laboratory Data Integrity’ in Mumbai. The conference provided information on detailed quality parameters required in a laboratory data management system.
Daara B Patel, Secretary – General, IDMA delivered the welcome address. He said, “Data Integrity is today one of the most crucial problems being faced by most pharmaceutical companies and it is well demonstrated by the number of registrations we have received.”
Speaking about the urgency of such workshop, Patel continued, “Most of the warning letters issued to different pharma companies in the recent past were on laboratory data integrity. The main focus of data integrity is on the QC department where a huge amount of data is handled. A lot of electronic data is generated during analysis as evidence to compliance to product specifications.”
Dr K Bangarurajan, Deputy Drugs Controller General (I), CDSCO was the chief guest of the event. He informed about the new Foreign Trade Policy 2015-2020 and the changes applicable to it. He also stressed on the importance of laboratory data integrity management and on why Indian pharma companies should make a habit to follow the required process.
As per information provided by the organisers, there were more than 150 participants from different pharma companies. R Raghunandan, Pharma Consultant, Former Vice President – Quality South Asia, GSK, AV Jayakumar, Vice President, – Corporate Quality, Ajanta Pharma, Sathya Sekhar Surabhi, Chief Executive Officer and President, Caliber Infosolutions, Sudesh Shetty, Director, Ernst and Young and T Lakshman Murthy, Senior GMP Auditor, USP India delivered presentations on different topics and informed the participants on how to tackle issues related to laboratory data integrity issues in the pharma industry.
Raghunandan emphasised that presented data to regulatory authorities should always be original. He pointed out that unless we report we are not going to improve and honesty is our most precious output. “Whatever you realise during a research work do report on that don’t make a mistake of fudging a falsify data,” he said. “Today the industry is facing one amongst the various challenges is that laboratory equipment are not updated,” he added.
Jayakumar mentioned that most of the data integrity problem today happens in pharma companies because of minimised use of chromatography applications. He also talked about the importance of ultra pure water for buffer preparation as de-ionised water many contain some organic compounds that can affect companies’ HPLCs performance. “So, I ask all the participants to request your companies’ management to have an ultra pure water system in place for a better outcome,” added Jayakumar.
Surabhi explained various parameters and procedures that need to be followed for better laboratory integration management within the laboratory and outside it. Shetty highlighted the steps that pharma companies’ management need to follow.
He briefed, “After receiving 483s or warning letters, most pharma companies have started firing the person responsible for it instead of training them. These people join another company with the same set of skills and knowledge and are bound to repeat the same mistake which they had done in their previous job. So companies are not resolving issues from the industry completely, in fact it is passed on to another. Management needs to train their staff efficiently instead of asking people to leave the organisation.”
The workshop ended with a panel discussion.