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)
- Plant authentication using macroscopic & microscopic characters
- Raw material testing parameters (Chemistry Manufacturing Controls) as per the Ayurvedic Pharmacopeia of India.
- Extraction Methods
- Types of Extraction Processes (Alcoholic, Hydro alcoholic & Aqueous)
- Extract drying processes (Freeze drying, Spray drying)
- Testing parameters of extracts as per the Ayurvedic Pharmacopeia of India or their official Monographs
- 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:
- Excipients to be used in the manufacturing process
- GMP for manufacturing process
- In-process controls checks
- Testing of Finished product as per the official monograph or In-house specifications & test methods
- Packaging & labelling of the finished product
Quality Control (Day-5 &6)
- Stability studies as per the ICH Q1 guidelines (stability sampling, intervals & shelf life period estimation)
- Storage conditions of Reference standards and control samples for the formulations and extracts.
- Methods used for the analysis of extracts and formulations.
- Familiarity with SOPs used in cGMP
- Types of water used in the Pharmaceutical Industries
(RO, Purified water, Raw water & water for Injection etc.)
- Importance of Effluent treatment plant in Pharma Industry
- Functions and application of AHU system in classified areas of cGMP facility.
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