How To Know About API || Active Pharmaceutical Ingredients || Pharma Guide
In these Active Pharmaceutical Ingredients plant, different types of departments are involved.
Those are 1. Production
- Quality control
- Quality assurance
- Research & Development
- Electrical & Mechanical Department
In Active Pharmaceutical Ingredients, two or more Ingredients are reacted at the certain temperature and it’s produced one product, it is commonly called as the Final product.
The starting two or more Ingredients are purchased from Bulk industry.
In these Active Pharmaceutical Ingredients, we are using different types of equipment’s, those are Reactors, centrifuges, filters, valves, dryers, condensers, and receivers.
Then we go for Documents,
The several Documents are
BMR- Batch manufacturing records
CR- Cleaning records
EUR- Equipment usage records
CR- Deviation records
SOP’s- Standard operating procedures
Temperature monitoring sheets
The process is involved in following steps, those are,
- Selection of Raw materials
- Weighing of Raw materials
- Mixing or agitation or stirring
- High heating
- Drying (water)
After finishing of labeling it is called as Final Product.
The Final product is sent to the Formulation plant through the vendor.