Pharmaceutical companies typically use a variety of factors to determine the price of their drugs, including: Development and production costs: Pharmaceutical companies invest significant amounts of money into the research, development, and production of new drugs. The cost of these activities, including clinical trials and obtaining regulatory approval, is factored into the price of the drug. Marketing and Distribution Cost: Marketing and distribution costs may also be considered by pharmaceutical companies when determining drug prices. These costs include expenses related to advertising, sales representatives, and distribution networks. Drug Uniqueness: If a drug is the first of its kind or represents a significant improvement over existing treatments, the pharmaceutical company may set a higher price for it. If a drug has many competitors or is like existing treatments, the company may have to set a lower price to remain competitive. Market demand: Companies also consider the dem
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:
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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