The training shall cover the following areas of the cGMP unit:
- Raw Material (Procurement & Storage)
- Extraction Unit
- Quality Assurance/ Quality Control
- 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
- 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.