"IIIM Jammu is in the process of creating a State-of-Art National Facility for small and medium scale manufacturers from north India and the state of J&K in particular to get their products manufactured under GMP/GLP conditions besides its use for research in IIIM" ...

Trainings Programmes


CSIR-IIIM unit for manufacture of herbal drugs is a State-of-the Art National Facility for small and medium scale manufacturers from north India and the state of J&K with a proclaimed objective of becoming a centre of excellence for advanced studies and research. It has been set up with the financial support of Department of Science and Technology (DST), Council of Scientific and Industrial Research (CSIR) and Dept. of AYUSH Govt. of India. The unit had been granted license by the J&K state regulatory authority (Food and Drug Control Organization) under License number JK/01/14-15/AY-UN/216, Dated: 30/01/2015 under Schedule T, Drug and cosmetic act 1940 and their rules) The facility is conceived to provide leadership in phyto-pharmaceuticals and other allied subjects.

CSIR –IIIM intends to conduct GMP and GLP Training for pharmaceutical professionals in India. This dedicated centre aims at creating commercial synergy between industry and academia. It will cater to the requirements with respect to training on current Good Manufacturing Practices (cGMP), Good Documentation practices (GDP), Good Laboratory practices (GLP),good agriculture and collection practices(GACP) and its allied areas. The training programme shall be conducted on the various aspects of GMP, GLP and QA/QC. Separate modules for practical training on analytical instruments, bio-evaluation of botanical activities are also envisaged.

The course is designed to understand the functioning of cGMP operations such as:

  1. cGMP extraction, formulation and packaging of botanical/ Phyto-pharmaceutical drugs.
  2. Analysis, calibration, trouble shooting, software handling, compilation of drug master file
  3. Preparation of New Drug Application (NDA) and Abbreviated New drug Application (ANDA) document for submission to the concerned regulatory authority.
  4. Filing of Electronic Common Technical Documents (eCTD)
  5. Preparation of Investigational New Drug Application (IND) document for submission to the concerned regulatory authorities.

 

Objectives

  • The main objective of CSIR- IIIM is to build a pool of trained manpower by enhancing practical and regulatory skills of science and pharmacy graduates and start up incubates. This shall enhance their employability by potential employers in the field of phyto-pharmaceuticals or allow them to set up their own pharma enterprises.
  • The facility to be used as Technology Business Incubator for promoting phyto-pharmaceutical sector by hand holding of young / start up entrepreneurs.
  • To develop training programs to match the requirements of the Pharma sector.
  • To utilize the expertise available with the faculty members of the Institute in solving specific problems of trainees in the area of production, quality control and method validation.
  • To organise lecture series by experts in the relevant areas of training.

 

Hands on Training Courses Offered by CSIR –IIIM

cGMP Training: Hands on training for M. Pharm / B. Pharm students towards partial fulfilment of their degree requirements.

  1. Extraction Process: Under this module the trainees shall be exposed to the various extraction processes for botanical raw materials. The students shall also have hands on the training on the following machines/ equipments/instruments
    • Extractor cum distillation
    • Distillator
    • Wiped film evaporator
    • Vacuum pan dryer
    • Vacuum tray dryer
    • Spray dryer
    • Plant material tray dryer
    • Grinder
    • Vibro sifter
  2. Tablet Section: Under this module the trainees shall be exposed to the various tablet manufacturing process of the APIs derived from botanical raw materials. The trainees shall also have hands on the training on the following machines/ equipments/instruments
    • Rapid mixer granulator
    • Tablet comprehension machine
    • Auto coater
    • Strip packing machine
    • Roller compactor
  3. Capsule Section: Under this module the trainees shall be exposed to the various capsule manufacturing process of the APIs derived from botanical raw materials. The students shall also have hands on the training on the following machines/ equipments/instruments
    • Semi-automatic capsule filling and sealing machine
    • Capsule polishing machine
    • Blister packing machine
    • Roller compactor
  4. Liquid Oral section: Under this module the trainees shall be exposed to the various liquid oral manufacturing process of the APIs derived from botanical raw materials. The trainees shall also have hands on the training on the following machines/ equipments/instruments
    • Liquid online preparation tank
    • Bottle washing machine
    • Automatic bottle filling, sealing and labelling machine
    • Cap sealing machine
  5. QC/QA: It is an essential component for the manufacture of botanical /Phyto-pharmaceutical products starting with raw material to the finished marketable products. This process includes important components such as authentication of the raw materials, chemistry manufacture and control (CMC), and maintenance of regulatory standards. The trainees shall be exposed to the following subjects:
    • High-performance liquid chromatography (HPLC)
    • Inductively Coupled Plasma Mass Spectrometry (ICPMS)
    • Liquid Chromatography Mass Spectrometry ((LC-MS/MS)
    • Gas Chromatography-Mass Spectrometry (GC-MS/MS)
    • Gas chromatography (GC)
    • Infrared spectroscopy (IR)
    • Ultraviolet- Visible spectroscopy (UV-Visible)
    • High-performance thin layer chromatography (HPTLC)
    • Dissolution and Disintegration apparatus
    • Wet lab
    • Stability chamber
    • Microbiology section
  6. Regulatory Affairs: In the area of Regulatory affairs, the trainees shall be exposed to the following subjects:
    • Compilation of Drug Master File (DMF) to different regulatory agencies like USFDA, CEP (Certificate of European procedures), Common Technical Document (CTD) for Therapeutics products Directorate (TPD), Therapeutics Goods Administration (TGA).
    • New Drug Applications (NDA) and Abbreviated New Drug Application (ANDA) filings
    • Electronic Common Technical Documents (eCTD) fillings
    • Investigational New Drug applications (IND)

 

Lectures/Seminars by Experts:

As a part of training modules, there will be a provision for arranging regular lectures by eminent experts in the following areas:

Quality Assurance/Quality Control:

  • Analytical method development and validation
  • Building & Equipment layout for drugs & Pharmaceuticals in API & formulations as per WHO GMP
  • Good Documentation practises (GDP) for preparation SOPs, SMF, BFR and other documents
  • Selection of packaging material
  • Pharmacopeia testing; expectations of regulatory agencies
  • Reference standards, test standards
  • Implementation of Schedule “M”
  • Qualification instruments and machineries like DQ, IQ, OQ, PQ
  • Dissolution testing & Stability testing
  • Calibration of Instruments.

Formulation Development in Tablet, Capsule & Liquid orals:

  • Pre formulation studies for desirable dosage forms like coated tablets (Enteric coating, sugar coating etc.)
  • Excipient compatibility studies
  • Pre-formulation testing parameters
  • Selection of packing material

Utilities and Services

  • Types of water used in the pharmaceutical grade (Raw water, purified water, RO water and water for injection) and their looping in the cGMP plant
  • Disposal of waste water management and chemicals (ETP, soakage pit etc)
  • Air handling unit (AHU) and classification of filters in the HVAC system.
  • Role of compressor and boiler in pharmaceutical industry.

Regulatory affairs:

  • Compilation of Drug Master File (DMF) to different regulatory agencies like USFDA, CEP (Certificate of European procedures), Common Technical Document (CTD) for Therapeutics products Directorate (TPD), Therapeutics Goods Administration (TGA).
  • New Drug Applications (NDA) and Abbreviated New Drug Application (ANDA) filings
  • Electronic Common Technical Documents (eCTD) fillings
  • Investigational New Drug applications (IND)

 

You may like to view further information on the following links:

  Short Term Modules Trainings - One week Training Programs
  Long Term Modules Trainings - 3 Months Training Courses
  Training Course - FAQs

 

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