Pharma

How To Know About API || Active Pharmaceutical Ingredients || Pharma Guide

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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

  1. Quality control
  2. Quality assurance
  3. Research & Development
  4. Electrical & Mechanical Department
  5. Stores

 

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

Logbook

 

Process:

The process is involved in following steps, those are,

  1. Selection of Raw materials
  2. Weighing of Raw materials
  3. Charging
  4. Mixing or agitation or stirring
  5. High heating
  6. Cooling
  7. Sedimentation
  8. Drying (water)
  9. Purification
  10. Drying(vacuum)
  11. Unloading
  12. Packing
  13. Labeling

 

After finishing of labeling it is called as Final Product.

 

The Final product is sent to the Formulation plant through the vendor.

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