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First step need to take For Starting a Pharmaceutical Company

Query: I am a veterinarian by profession. Have been going through your website from past 1 year and have planned now to give a start to my own pharma company. Please let me know what will be the first step I need to take.  Answer: First Step you need to prepare yourself for Pharmaceutical Company:  Preparation means Choose marketing type, Choose molecules want to launch, Location where you want to launch product, Choose Company, Products Name, Budget available...  Choose marketing type: As number of marketing and selling types present in pharmaceutical market. i.e. Branded Marketing , Generic Marketing , OTC Marketing, Franchise Marketing etc. You need to select any one from above.  Choose Molecule: Once you have selected which marketing type is best suitable for you then you need to select at which segment and molecules you want to work. Check out: How to choose products/service for business? Location: You can't launch your pharmaceutical company all over India or at broad area.

Batch Number/ Lot Number

Batch number or Lot number is an serial number or reference given to the record of manufacturing process of a specific quantity of formulation manufactured in single manufacturing order during the same cycle of manufacture and printed at label of the formulation that allows the history of its production to be traced.
Standard Operating procedure of Batch Numbering:
  • There shall be Standard Operating Procedures describing the details of the batch (lot) numbering set up with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number.
  • Batch numbering Standard Operating Procedures applied to a processing stage and to the respective packaging stage shall be same or traceable to demonstrate that they belong to one homogenous mix.
  • Batch number allocation shall be immediately recorded in a logbook or by electronic data processing system.

Batch Number is a part of batch manufacturing record and manufacturing record maintains the following particulars:
  • Serial Number
  • Name of product
  • Master Formula Record Reference
  • Batch/Lot Size
  • Batch/Lot Number
  • Date of starting of manufacturing and completion of manufacturing
  • All ingredients list with quantity for particular lot/batch size
  • Different processed conducted during manufacturing process with time and date
  • Environmental Control details 
  • In process quality control processes
  • Analytical test reports 
  • Signature of competent technical staffs
  • Date of release of finished pharmaceutical products etc

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