The newly-opened the Small and Medium Pharmaceuticals Industry Centre (SMPIC) at National Institute of Pharmaceutical Education and Research (NIPER), Punjab will be holding a number of training programmes on different aspects on pharma industry starting later this month, in line with its projected goal of helping the SME sector.
The training programmes for SME would be held on the aspects of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Clinical Trial writing protocols. It has finalised six programmes of five days and the first one will begin on March 23 and the workshops will also extend hands-on training one some aspects, it is learnt.
After long standing demands by the small sector, the SMPIC has been finally set up to provide training and instruments/equipment used in manufacturing of Active Pharmaceutical Ingredients (APIs) and formulations, guidance on GMP, GLP, documentation on various regulatory requirements and SOP's, with a view to help small and medium players to face the challenges and get upgraded to the tasks.
In each training programme for GLP and GMP, there will be fifteen lectures of one and a half hour duration. Three lectures will be held every day, two in the morning session and one in the afternoon session. This will be followed by demonstrations in the Technology Development Centre (TDC), Central Instrument Laboratory (CIL), Central Animal Facility (CAF) etc. First in the series will be held from March 23 to 27, to be followed by another one from May 18 to 22. Then there will be workshops from July 27-31, September 21-25, November 23-27 and December 14-18 this year.
Lectures will be selected from the topics like revised Schedule M
(GMP) and its implementation, WHO Certification Scheme, design and maintenance of pharmaceutical facilities, sanitation and environment monitoring, water for pharmaceutical use, clean room concepts and validation (process, equipment and cleaning), essentials of quality assurance and quality control, air conditioning system (HVAC) for pharma SMEs, pharmaceutical plant design, documentation, SOPs, SMF, BFR, and other documents, validation of processes, GMP on shop floor, importance of training, safety and waste management including storage and safe handling of chemicals, guidelines on GMP for heating and ventilation, analytical functions in SSI in light of revised Schedule M, microbiological testing, GC and HPLC: principles and applications, analytical method validation.
Likewise, different aspects of API formulations, regulatory requirements, testing procedures, significance of quality control and quality assurance, GLP, and impurity profiling will also be covered in these programmes. The speakers will include experts from the industry, academia, regulatory and testing laboratories.