Schedule L1, GLP on board !

Thanks to Mr Shirgaonkar for this wonderful information !
Knowledge of Good Laboratory Practices is very important in Pharmaceutical industry.
New GLP requirements as per Schedule L1 of Drug Rules will come into effect from 1st November 2010. Topics such as General laboratory requirements,instruments calibration, microbiological testing and internal audit will be covered in this statutory requirement.
It was announced that Ministry of Health has recently notified the Schedule L-1 of Rule 74,78 and 150 E under Drugs and Cosmetics Third Amendment Rule 2008 giving the pharmaceutical industry time till November 1, 2010 for compliance.
The implementation of GLP and the responsibility of companies to comply with them while carrying out quality analysis. GLP stresses on the maintenance of documented quality systems as per the quality manual laid down by the manufacturing unit, and on the technical audit of the quality control laboratory for GLP compliance by an expert/experts appointed by the top management other than the person in charge of the laboratory.
As Mr. Shirgaonkar organises a workshop on GLPs and highlight the incumbent Schedule L1, to know more visit Insight Systems website

National Seminar on “Road Map to the Indian Drug Industry”, 15th – 16th September, 2008

The seminar was inaugurated by the Chief Minister of Andhra Pradesh Dr Y Rajasekhar Reddy by liting lamp along with Dr. K Anji Reddy, Chairman Dr Reddy's Laboratories Limited. Dr. K. Anji Reddy was felicitated by Chief Minister by presenting a shawl as a souvenir.
Speakers in the seminar from different disciplines of Drugs & Pharmaceuticals industry shared their experiences, thoughts and contemporary trends in the fields of drug discovery, IPR, International developments, Manufacturing, GMPs, SHE, IT and Automation.
The most inspiring speech was made by Dr K Anji Reddy in which he informed the audience of his experience, efforts and strategies of tilting the export balance of APIs in India’s favor. In his witty style, he narrated how Dr Reddy’s Labs thought of the IPR regime well in advance and prepared for the drug discovery research.
On the second day of seminar, CEO of Dr Reddy’s, Mr. GV Prasad highlighted the importance of sustainability. At the backdrop of world wide financial & business fluctuation, rise and fall of oil prices and capability of Chinese manufacturers, Mr. GV Prasad explained the audience for the available alternatives. Amidst the challenges to the Indian Pharma companies, he shared his innovative idea of ‘seeing quality from different angle’ and therefore, as an effort for this, how Dr Reddy’s is being benefited by a Japanese consultant who is from an engineering industry background. Mr. GV Prasad also informed about the efforts being made by Dr Reddy’s on Strategic Partners side wherein the company is working for the development of their vendors as a win-win model.
The other eminent speakers include APSIDC MD, MR BP Acharya (IAS), Mr. Sam Bob (IAS), Principal Secretary; Ministry of Commerce who explained the general industrial policy of the state and in particular to SEZs which are being developed.
While, Dr. Lalji Singh from CCMB described the challenges and opportunities available through stem cell research, Dr. Venkatswaralu (former Drug Controller General) emphasized on meeting GMP requirements. Dr. Venkatswaralu highlighted the importance of Human Resource vis-à-vis continuous training and development. He underlines the concerns on ambiguities and inadequacies in GMP documents. He asked the forum that how many companies are auditing Chinese manufacturers and suppliers. He wondered that should we also wait for a Heparin type incident to initiate that.
The other important speakers were Dr. Sengupta (Member Secretary, CPCB and Planning Commission), Mr. Kjell Olsen from GTZ, Mr. S. Mani (VP-SHE, Orchid), and Mr. P Shamugama Sundram from TUV and Rajiv Sodhi from Microsoft.
The seminar presented a vista of information. On one side government policies on infrastructural development and support were conveyed, on the other side the challenges of the next decade were discussed. Mr. P Shamugama Sundram from TUV deliberated the latest requirement of REACH certification as per the new European directive 1907/2006. He further explained the difference between MSDS and CSR requirements for chemical industries.

Training for Trainers - AIMA workshop at Mumbai

It was a good opportunity to attend three days training workshop on 'Training of Trainers' organised by All India Management Association. The workshop was attended by 35 persons from different companies across the country.

The Faculty was - Dr. Sunil Abrol who is well known figure in the domain of Management and Organisational behaviour. He explained different elements related to effective organising of training programs.

The program addresses the following:

1. Five principles of adults learning;
2. Training objectives,
3. Training Needs Identification / Assessment;
4. Techniques for presentation and presentations skills;
5. Learning Strategies;
6. Training Models;
7. Training Evaluations.
8. The program was a good learning experience.

Besides, fun and learning, the program also provided a good networking opportunity. The participants, which were HR or Training professionals shared there experiences on handling different types of trainings, viz. behavioural trainings, technical conclaves and motivation trainings.

In all the overall experience was good and full of learning.

KOEL Second Meet - Towards Maturity!!

Yes that's true. The recently concluded meet of KOEL at Mumbai was a great success. This is a sign of maturity, as this was a well planned, well informed and well attended meet where the members participated from different parts of the country. And also this was the second consecutive KOEL conference !

Moving ahead ! Cheers buddy's - keep it up !

Despite of my wholehearted desire to participate and meet all old colleagues, I could not make it. But, the very thought of KOEL approaching towards maturity is exciting and as well as promising.

So, see you guys next time, in the third KOEL meet !