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

E-mail : smpic@niper.ac.in Website : www.niper.gov.inSector-67, S.A.S. Nagar (Mohali), Punjab - 160062, Tel : 91-172-2214682-2214687, Fax: 91-172-2214692

National Institute of Pharmaceutical Education and Research, S.A.S Nagar (NIPER-S)An Introduction

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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.

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

Objectives

For more information on other central facilities in the Institute, please visit: www.niper.gov.in

Date of publication : 10 December, 2011

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National Institute of

Pharmaceutical Education and Research S.A. S. Nagar (NIPER-S)

Small and Medium Pharmaceutical Industry Centre (SMPIC)

SMPIC

NIPER-S has been conducting GMP and GLP trainings Medium Pharmaceutical Industry Centre (SMPIC). This dedicated centre aims at creating commercial for pharmaceutical professionals in India for the last synergy between industry and academia.five years. NIPER-S had successfully conducted 53

training programs under the World Bank sponsored It will cater to the requirements with respect to training Capacity Building Project for the staff from on Good Manufacturing Practices (GMP), Good Government Testing Laboratories, Regularity bodies, Laboratory Practices (GLP) and allied areas. Under Private Testing Laboratories and Analytical as well as this plan, seminars and short term training Production Staff from Small and Medium programme shall be conducted on the various aspects Pharmaceutical Industry (SMPI). Department of of GMP and GLP. Separate modules on sophisticated Pharmaceuticals, Government of India announced the practical training on analytical instruments are also setting up of a dedicated centre for SMPI at planned. The training programs have been designed in Pharmaceutical Advisory Forum (PAF) on 23rd April consultations with SMEs. An additional objective of 2008. Keeping the stake holder's demand in view, SMPIC is to build a pool of trained manpower by NIPER-S had initiated training program to train and enhancing practical skills of students of science and up-date the knowledge of staff from SMPI. For the technology. This shall enhance their employability by same, NIPER-S has set up a dedicated Small and potential employers from SMEs.

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dObjectives

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.

Hands on training courses offered by SMPIC

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.

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.

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High Performance Liquid Chromatography (HPLC) Gas Chromatography (GC) High Performance Thin Layer Chromatography (HPTLC) Ultraviolet and Visible Absorption Spectroscopy (UV-VIS)

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FT-IR Spectroscopy (FTIR) Atomic Absorption Spectroscopy (AAS) Dissolution Apparatus

SMPIC

at Glance

Seminar / Workshops Organized

S. No. Title of the Program Date Participants Attended

1. Good Manufacturing Practices (GMP) 23 – 27 March 2009 11

2. Good Laboratory Practices (GLP) 18 – 22 May 2009 13

3. Good Manufacturing Practices (GMP) / 27 – 31 July 2009 14Good Laboratory Practices (GLP)

4. Good Manufacturing Practices (GMP) / 21 – 25 Sept.2009 11Good Laboratory Practices (GLP)

5. Good Manufacturing Practices (GMP) / 14 – 18 Dec. 2009 16Good Laboratory Practices (GLP)

6. One Day Seminar on Documentation 21st August 2010 137Requirement for the Pharma Industry

7. One Day Seminar on Common 21st January 2010 82Technical Document

8. One Day Seminar on Validation 30th April 2011 91

9. One Day Seminar on Risk Analysis 26th August 2011 44

Hands on practical trainings on

HPLC, GC & AAS, UV & IRSo 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

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Good Laboratory Practices (GLP) : issues such Material of construction used in manufacturingas validation, standardization, calibration, Implementation of Schedule “M”safety etc.

Standard testing proceduresRegulatory requirements of pharmaceutical quality control: ICH, WHO and other guidelines Clean room concepts including HVAC system

Quality control and quality assurance Water system

Analytical method development and validation SOPs, SMF, BFR and other documents

Drugs and Cosmetics act and provisions Safety aspects : hazards appraisal & control, disaster planning (on-site & off-site), toxicity Analytical functions in SME in light of revised hazards of some selected organic/inorganic Schedule 'M' chemicals & method of handling and explosives

Pharmacopoeial testing : expectations of WHO certification schemeregulatory agenciesSelection of packaging materialReference standards, test standards and

reagents Validation: IQ, PQ, OQ

Dissolution testing Inventory Control

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

SMPIC

Why to attend the seminars / workshops?

Analytical Instruments available in SMPIC

By attending the seminars / workshop the participants will get an opportunity to know more from the experts about:

technical knowledge, international standards and regulationsregulatory requirements at various stages of production and marketing of drugspreparation 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.

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 ViscometerPolarimeter Refractometer Dissolution ApparatusKarl Fischer Apparatus

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.

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For APIs

For Formulations*

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On-Site Training at Your Facility•

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

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 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