The Pharmaceutical Forum-Aurangabad chapter sees good turnout
Sachin Jagdale – Mumbai
Speakers at the event were (from right to left) Anil Chitnis, retd. SR Corporate Risk Manager, GSK Pharmaceuticals India; Kapil Bhargava, retd. Deputy Drugs Controller of India; R Raghunandanan, retd. V P Quality, South Asia, GSK Pharmaceuticals, India; Dr Hemant Mondkar, Head-Quality Assurance, Teva India and Maitreya Mudkavi, from the organiser’s side
Anil Chitnis, retd. SR Corporate Risk Manager, GSK Pharmaceuticals India speaks on risk assessment
| Kapil Bhargava, retd. Deputy Drugs Controller of India shares his views on key
issues in auditing
The pharma forum, Aurangabad chapter, an initiative by Shodh HR and Services concluded recently with a huge success. Though it was the first such initiative by Shodh the auditorium was packed up to its capacity. Senior pharma professionals from reputed pharma companies from the Aurangabad, Pune, Nasik, Nagar etc regions attended the event in large numbers. It was a forum for sharing new ideas, concepts and latest practices in the pharma domain. To provide cost effective yet quality training and inculcate a healthy learning environment among the pharma professionals to hone their skills were the targets set by the organizers
for themselves. R Raghunandanan, retd. V P Quality, South Asia, GSK Pharmaceuticals, India, Anil Chitnis, retd. SR Corporate Risk Manager, GSK Pharmaceuticals India and Kapil Bhargava, retd. Deputy Drugs Controller of India were the speakers at the event. These experts with decades of experience in their respective fields spoke about cGMP, environment, health and safety (EHS), good laboratory techniques, plant engineering and energy audits, audit preparations, Do’s and Dont’s during audits, good warehouse practices and intellectual property rights related to pharma.
The entire event was made lively with very informative presentations by speakers. Participants were also equally enthusiastic about the topics that speakers spoke about.
“This event was very beneficial for all participants. It was very neatly arranged technical seminar. All three topics selected were very important for the pharma professionals. In this event the first topic was on Schedule L for Good Laboratory Parctices (GLP). Now we have understood the exact requirements of Schedule L. Documentation system will also be improved. The detail discussion in this seminar will help to implement Schedule L. One of the very important points discussed is productivity in laboratory. Productivity in Laboratory is one of the important aspect in laboratories which is covered in this Schedule L. It will help to reduce the cost of analysis,” opines Mahesh Tamane, Manager, QA, Indoco Remedies. He adds, “The second topic, EHS Risk assessment, was also very important for laboratory safety point of view. So many case studies were discussed by the speaker to prevent the accidents, injury and illnesses in our plants. Health and safety of employee should be our prime motto. Discussion on non-conformities in regulatory audits will be useful to avoid the deficiencies in our day to day basis and in audits. Overall all the topics were very important and beneficial for up-gradation of knowledge for all the participants. All the three speakers were experts in pharma field. They have rich knowledge in their respective areas. They have shared their knowledge which is helpful to me and at the same time I have started implementing the same in my plant.”
Raghunandanan spoke about Quality Management System (QMS) requirements vis-a-vis statutory requirements. New Schedule L-1 on Good laboratory Practices (GLP) will be effective from November 1st, 2010. Raghunandan informed participants about how to prepare for this. Participants also discussed many issues about Schedule L-1 with Raghunandanan. However, on the other hand Raghunandanan and Bhargava raised doubts over some of the points mention in the Schedule L-1 guidelines which were not clearly indicating the steps to be taken by the laboratories.
Chitnis’s views on EHS risk management was also the highlight of the event. Speaking about the necessity of the risk management Chitnis said, “Risk assessment and management can help ensure that the most important exposures and hazards are tackled ahead of lesser ones and that resources are spent where the greatest opportunities to reduce risk exist. The practice of risk assessment has evolved into a valuable tool in helping policy makers decide on what level of risk is acceptable to society. Managing risk and developing effective strategies to ensure risks are controlled, transferred and retained properly is critical for any organization.”
Bhargava’s lecture on Non-Conformities in regulatory audits was also well received by the pharma managers, QA heads, regulatory professionals etc. He informed participants about approaches of inspectors and their way of finding non-conformities with easy to understand examples.