"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" ...

Short Term Modules Trainings - One week Training Program


One week Training program (cGMP Unit):

Training shall be imparted through lectures by the experts and through Practicals in the area of extraction, formulation, QA/QC, and Utilities etc.

Extraction (Day 1 & 2)

  1. Plant authentication using macroscopic & microscopic characters
  2. Raw material testing parameters (Chemistry Manufacturing Controls) as per the Ayurvedic Pharmacopeia of India.
  3. Extraction Methods
  4. Types of Extraction Processes (Alcoholic, Hydro alcoholic & Aqueous)
  5. Extract drying processes (Freeze drying, Spray drying)
  6. Testing parameters of extracts as per the Ayurvedic Pharmacopeia of India or their official Monographs
  7. CMC of APIs (extract)

 

Formulation Unit (Day 3 & 4)

The trainees shall work in the formulation unit to learn about the Good Manufacturing Practices involved in the preparation of AYUSH formulations (Oral dosage forms: Tablets, Capsules & Liquid Orals). The topics to be covered include:

  1. Excipients to be used in the manufacturing process
  2. GMP for manufacturing process
  3. In-process controls checks
  4. Testing of Finished product as per the official monograph or In-house specifications & test methods
  5. Packaging & labelling of the finished product

 

Quality Control (Day-5 &6)

  1. Stability studies as per the ICH Q1 guidelines (stability sampling, intervals & shelf life period estimation)
  2. Storage conditions of Reference standards and control samples for the formulations and extracts.
  3. Methods used for the analysis of extracts and formulations.
  4. Familiarity with SOPs used in cGMP


Utilities

  1. Types of water used in the Pharmaceutical Industries
    (RO, Purified water, Raw water & water for Injection etc.)
  2. Importance of Effluent treatment plant in Pharma Industry
  3. Functions and application of AHU system in classified areas of cGMP facility.

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