Impurity profiling of Pharmaceutical products: A Regulatory Requirement

Jul 07, 2018 19:15 | Chandigarh

Seminar held at NIPER’s SMPIC (Small and Medium Pharmaceutical Industry Centre)


One day seminar on ‘Impurity profiling of Pharmaceutical products: A Regulatory Requirement’, held at NIPER’s SMPIC on 7th July, 2018. The centre organizes seminars on issues related to GLP, GMP and other allied areas. In these series, SMPIC with Indian Pharmaceutical Association (IPA), New Delhi jointly organized a one day seminar on ‘Impurity profiling of Pharmaceutical products: NIPER’s SMPIC at S.A.S. Nagar is set up under the ministerial guidelines to support/to cater the needs of Indian Pharmaceutical Induatry. The centre aims at creating commercial synergy between industry and academia.  

 

The inaugural session was held with welcome address of Director, NIPER Prof. Raghuram Rao Akkinepally. Dr. Rao welcomed all the distinguished guests Dr Jens Boertz, Pharmaceutical Product Manager, LGC -Germany, Dr Naresh Sharma, Deputy Drugs Controller (India), CDSCO, DGHS, MoHFW, India , Dr Mymoona Akhtar, Associate Prof. SPER, Jamia Hamdard and Mr Sidharth Sahai Malhotra, DI,CDSCO, New Delhi. Inchage SMPIC Prof. Arvind Bansal was present in the seminar.

 

Pharmaceutical impurities are the unwanted chemicals which are introduced during the manufacturing process for drug substance, drug product, excipient or during their storage. Theses impurities should be controlled throughout the manufacturing process as these can affect safety of medicines. It is therefore, important to have an accurate detection of impurities.

 

Dr Jens Boertz, (Pharmaceutical Product Manager, LGC , Germany detailed about “The Global regulatory context for impurity testing  and Characterisation  of Impurity Reference Standards  were delivered  by LGC team Germany.

 

Dr. Mymoona Akhter,Associate Professor,SPER, Jamia Hamdard, delivered lecture on

Impurities- Regulatory Requirements

The seminar provided an insight into the regulatory aspects of  Impurity Profiling of Pharmaceutical Products, testing of the Pharmaceutical impurities, characterization of reference standards and  regulatory requirements on usage of Impurity Standards. All the topics were discussed at length by the experts, eminent personalities from regulatory agencies of GOI and Germany.