National Institute of Pharmaceutical Education and Research, S.A.

S Nagar (NIPER-S) An Introduction

NIPER-S is the first national level institute in pharmaceutical sciences with a proclaimed objective of becoming a centre of excellence for advanced studies and research. The Government of India has declared NIPER as an 'Institute of National Importance' by an act of parliament in 1998. It is an autonomous body set up under the aegis of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. The Institute is conceived to provide leadership in pharmaceutical sciences and related areas not only within the country, but also to the countries in south east Asia, south Asia and Africa. NIPER-S is a member of Association of Indian Universities and Association of Commonwealth Universities.

Objectives
The main objectives of the Institute are: To nurture and promote excellence in pharmaceutical education and research To conduct courses for teachers, pharmaceutical technologists, community pharmacists and other professionals in pharmaceutical field To create a central facility of pharmaceutical instrumentation for use by the researchers within and outside the institute To create national centres to cater to the needs of pharmaceutical industry To develop an information centre with literature of pharmaceutical sciences and technology for use by other institutions To develop a centre with state of the art facilities for creation of new knowledge and transmission of existing information in pharmaceutical areas To arrange courses catering to special needs of developing countries To act as nucleus for interaction between academia and industry by encouraging exchange of scientists between the institute and industry To undertake consultancy projects For more information on other central facilities in the Institute, please visit:

Value through participation

SMPIC
Small and Medium Pharmaceutical Industry Centre (SMPIC)
Printed at : Azad Hind Stores (P) Ltd., Tel.: 0172-2704511-14

www.niper.gov.in

National Institute of Pharmaceutical Education and Research (NIPER-S)

Sector-67, S.A.S. Nagar (Mohali), Punjab - 160062, Tel : 91-172-2214682-2214687, Fax: 91-172-2214692 E-mail : smpic@niper.ac.in Website : www.niper.gov.in
Date of publication : 10 December, 2011

National Institute of Pharmaceutical Education and Research

S.A. S. Nagar (NIPER-S)

SMPIC

Objectives
To develop training programs to match the requirements of the SME pharma sector. To offer the spare time of common instruments in NIPER, to SME Pharma companies on a cost sharing basis. To utilize the expertise available with the faculty members of the Institute in solving specific problems of SME Pharma companies. To train science and pharmacy graduates in the state-of-the-art instrumentation facilities and regulatory requirements. These trained personnel will be offered responsible positions in SME in pharma companies so that the latter are able to compete in the business scenario. SMEs need to develop a mechanism by which they will be able to recruit and retain this highly skilled and trained workforce. To develop and assist SME Pharma units to meet global challenges, besides Schedule M, Good Laboratory Practices and other regulatory requirements. To provide and coordinate other services of NIPER faculties.

Background

Hands on training courses offered by SMPIC

FT-IR Spectroscopy (FTIR) High Performance Liquid Chromatography (HPLC) Atomic Absorption Spectroscopy (AAS) Gas Chromatography (GC) High Performance Thin Layer Chromatography (HPTLC) Dissolution Apparatus Ultraviolet and Visible Absorption Spectroscopy (UV-VIS)

Training combined with hands-on experience, is a useful combination that will help SME Pharma personnel to understand the latest analytical techniques and explore their application in various fields. These training courses are being conducted regularly in SMPIC. NIPER-S has been conducting GMP and GLP trainings for pharmaceutical professionals in India for the last five years. NIPER-S had successfully conducted 53 training programs under the World Bank sponsored Capacity Building Project for the staff from Government Testing Laboratories, Regularity bodies, Private Testing Laboratories and Analytical as well as Production Staff from Small and Medium Pharmaceutical Industry (SMPI). Department of Pharmaceuticals, Government of India announced the setting up of a dedicated centre for SMPI at Pharmaceutical Advisory Forum (PAF) on 23rd April 2008. Keeping the stake holder's demand in view, NIPER-S had initiated training program to train and up-date the knowledge of staff from SMPI. For the same, NIPER-S has set up a dedicated Small and Medium Pharmaceutical Industry Centre (SMPIC). This dedicated centre aims at creating commercial synergy between industry and academia. It will cater to the requirements with respect to training on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and allied areas. Under this plan, seminars and short term training programme shall be conducted on the various aspects of GMP and GLP. Separate modules on sophisticated practical training on analytical instruments are also planned. The training programs have been designed in consultations with SMEs. An additional objective of SMPIC is to build a pool of trained manpower by enhancing practical skills of students of science and technology. This shall enhance their employability by potential employers from SMEs. SMPIC is conducting hands-on training for SME Pharma personnel and science and pharmacy students, since 2009. Each of our hands-on courses is designed to help analytical staff from pharma companies to gain the skill that are needed in the area of GLP compliance. Duration of the each of the above hands on practical trainings is five days with maximum 8 trainees per batch that allows for optimum interaction and instruction. The course is designed to aid in understanding the operation, daily working, analysis, calibration, troubleshooting and software handling. On-site training programs may also be offered as per specific requirement.

Hands on practical trainings on HPLC, GC & AAS, UV & IR

SMPIC at Glance
Seminar / Workshops Organized
S. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. Title of the Program Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) One Day Seminar on Documentation Requirement for the Pharma Industry One Day Seminar on Common Technical Document One Day Seminar on Validation One Day Seminar on Risk Analysis Date 23 27 March 2009 18 22 May 2009 27 31 July 2009 21 25 Sept.2009 14 18 Dec. 2009 21st August 2010 21st January 2010 30th April 2011 26th August 2011 Participants Attended 11 13 14 11 16 137 82 91 44

So far more than 400 participants from SME Pharma companies and academia have utilized these trainings (all over India enhance their skills).

Potential Topics for future seminars / workshops

Good Laboratory Practices (GLP) : issues such as validation, standardization, calibration, safety etc. Regulatory requirements of pharmaceutical quality control: ICH, WHO and other guidelines Quality control and quality assurance Analytical method development and validation Drugs and Cosmetics act and provisions Analytical functions in SME in light of revised Schedule 'M' Pharmacopoeial testing : expectations of regulatory agencies Reference standards, test standards and reagents Dissolution testing Documentation in an analytical laboratory Stability testing Quality testing issues of biological and biotech products Building & equipment layout for drugs & pharmaceuticals in API & formulations as per WHO GMP Material of construction used in manufacturing Implementation of Schedule M Standard testing procedures Clean room concepts including HVAC system Water system SOPs, SMF, BFR and other documents Safety aspects : hazards appraisal & control, disaster planning (on-site & off-site), toxicity hazards of some selected organic/inorganic chemicals & method of handling and explosives WHO certification scheme Selection of packaging material Validation: IQ, PQ, OQ Inventory Control

Why to attend the seminars / workshops?

By attending the seminars / workshop the participants will get an opportunity to know more from the experts about: technical knowledge, international standards and regulations regulatory requirements at various stages of production and marketing of drugs preparation and maintenance of various documentations, dossiers and CTD The workshop will follow an exclusive interactive sessions that shall address scientific queries in an effective manner. SMPIC will provide an impartial setting that fosters sharing of information between industry, government, academia and individuals, thus providing valuable linkages across a wide spectrum of interest in the pharmaceutical industry.

For APIs
Corrosion and its prevention : corrosion characteristics of some selected organic/inorganic chemicals construction Pollution and pollution control: Concept of types of pollution, ecology & ecology balance, pollution & health hazards, gaseous pollution control, water pollution and control Scale up in all industrial activity / filtration process

Analytical Instruments available in SMPIC

High Performance Liquid Chromatography (HPLC) High Performance Thin Layer Chromatography (HPTLC) Gas Chromatography (GC) FT-IR Spectroscopy (FTIR) Ultraviolet and Visible Absorption Spectroscopy (UV-VIS) Atomic Absorption Spectroscopy (AAS) Spectrofluorimeter Viscometer Polarimeter Refractometer Dissolution Apparatus Karl Fischer Apparatus

For Formulations*
Problems in tablet and capsule manufacturing and their solutions Problems in manufacturing of oral liquid formulations * GMP compliant formulation plant shall be ready in near future. SMPIC can tailor each of these courses to meet your specific need to help your organization reach its goals. Our programs are designed to be educational, energizing and inspiring, ranging from one - five days seminars.

On-Site Training at Your Facility

On-site training programs / seminars can be conducted on specific requests. On-site courses bring the classroom learning experience to your company's facilities as per the specific needs

About 75 SME Pharma companies have become members of SMPIC. SMPIC membership form is available on the NIPER website i.e., www.niper.gov.in/smpic_membership.pdf * Registered pharma SME Units are entitled for 50% discount on various services like analysis and consultancy projects.

SMPIC Training Calendar for the Year 2012 Hands on Practical Training on High Performance Thin Layer Chromatography (HPTLC), High Performance Liquid chromatography (HPLC), Gas Chromatography (GC), Atomic Absorption Spectroscopy (AAS) and Spectroscopy (UV-Vis & FTIR) Dates Instruments 9-13 January GC and FTIR 16-20 January HPLC 30 January-3 February GC and FTIR 6-10 February HPLC 27 February-2 March HPLC 26-30 March Spectroscopy 12-16 March HPLC 9-13 April HPLC 23-27 April GC and FTIR 30 April- 4 May HPLC 7-11 May Spectroscopy 14-18 May HPLC 21-25 May GC and AAS 28 May-1 June HPLC 4-8 June HPLC 11-15 June GC and AAS 18-22 June HPTLC 2-6 July GC and FTIR 9- 13 July HPLC 30 July -3 August Spectroscopy 27-31 August GC and AAS 3-7 September HPLC 10-14 September Spectroscopy 24-28 September HPTLC 8-12 October GC and FTIR 15-19 October HPLC 5-9 November GC and AAS 19-23 November HPLC 3-7 December GC and FTIR 10-14 December HPLC 17-21 December Spectroscopy The number of participant may vary from 4 to 6. For further details contact: National Institute of Pharmacutical Education and Research (NIPER) Small and Medium Pharmaceutical Industry Centre (SMPIC) Block-G, Sector-67, Phase 10, SAS Nagar, Mohali, Punjab 160062 E-mail: smpic@niper.ac.in