"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" ...

Long Term Modules Trainings - 3 Months Training Course


The training shall cover the following areas of the cGMP unit:

  1. Raw Material (Procurement & Storage)
  2. Extraction Unit
  3. Quality Assurance/ Quality Control
  4. Formulation
  5. Packaging
  6. Exposure to utilities and Services

 

Extraction (Week 1-3)

  • Good Agriculture and Collection Practises (GACP) and storage of raw drugs.
  • Plant authentication using macroscopic & microscopic characters.
  • Accession of different lots in Herbarium/ Crude Drug Repository
  • Passport data of raw material.
  • Drying techniques of crude drugs
    Raw material testing parameters (Chemistry Manufacturing Controls) as per the Ayurvedic Pharmacopeia of India
  • Extraction Methods and types of extraction processes (Alcoholic, Hydro alcoholic & Aqueous)
  • Cleaning of equipments, QA clearance, and Raw material quality check.
  • Extract drying processes (Freeze drying, Spray drying)
  • Testing parameters of API (extract) as per the Ayurvedic Pharmacopeia of India or their official Monographs and CMC thereof.
  • Packaging conditions of the Extract powder.

 

Formulation (Week 4-8 )

  • Receiving and storage of raw material procedures
  • Man and material entry procedures
  • Manufacturing processing area (Oral Dosage forms i.e. Tablet, Capsule & Syrups)
  • Packaging procedures
  • Quality control section (Microbiology, Stability chambers)
  • Finished goods stores
  • Office
  • Rejected goods/drug store
  • Regulatory requirements

 

Qualiy Assurance/ Quality Control section

  • Instruments like Hardness, Fraibiliator, Dissolution, Disintegration, UV-Vis spectroscopy etc.
  • Stability sampling, Intervals and stability evaluation
  • Calibration methods & trouble shootings of HPLC, GC, LC-MS, GC-MS etc.

 

Rotation mode for entire IIIM Labs. (Week 9-12)

All the trainees will be asked to give their choice with respect to any three of the divisions/ sections/ facilities of the Institute for rotation for a period of 1 week each.

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