Batch Manufacturing Records for Ayurvedic, Unani and Siddha medicine manufacturing unit

Batch Manufacturing Records:

For Ayurvedic, Siddha and Unani medicines manufacturing unit, keeping record of various activities i.e. raw material, packaging material, finished goods, man power, machinery used, technical persons and other activities is essential. Batch manufacturing record is also an essential document for Ayurvedic, unani and siddha medicines.

A Batch manufacturing record is a document which contains all details about manufacturing of a particular batch or Lot. Each manufacturing record has given a number that is known as Batch number/Lot number.

It is compulsory for ayurvedic, unani and siddha medicines manufacturing unit to maintain a manufacturing record for each and every batch, and has to present before concern authority if demanded by authority.

Details in Batch Manufacturing Record:
  • Serial number
  • Batch Number
  • Brand Name of Ayurvedic, Unani or Siddha Product
  • List of Ingredients with Dosage Form, Part used etc
  • Batch Size/Lot Size
  • Date of Manufacturing and Date of Expiry
  • Maximum Retail Price
  • Master Formula Record Reference detail
  • Date of starting of manufacturing and date of completion of manufacturing process.
  • Date and time of every single step taken during manufacturing of product including analytical procedures with signature and name of person present during this process.
  • Name and signature of competent staff present during each and every step
  • Grade and quality of all ingredients checked by quality control department
  • Control Reference number of all ingredients
  • Time period for steps and activities carried out during manufacturing process
  • Quality Assurance Standards and environmental activity records whenever applicable like pH of solutions, filter integrity testing, temperature and humidity etc
  • Date and Time of Test Sample taken & results of each test conducted during manufacturing process and after manufacturing process like weight, leak test, hardness test, fragility test etc whenever applicable
  • Inspection Records
  • Machinery, Equipment and other applicable things
  • Washing record
  • Reference number of relevant analytical reports
  • Packaging material details and specimen of printed packaging material etc

Drug and Cosmetic Act Describes the Batch manufacturing Record as follow:

The licensee shall maintain batch manufacturing record of each batch of Ayurvedic, Siddha and Unani drugs manufactured irrespective of the type of product manufactured (classical preparation or patent and proprietary medicines). Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940). These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. These records shall be duly signed by Production and Quality Control Personnel respectively. Details of transfer of manufactured drug to the finished products store including dates and quantity of drugs transferred along with record of testing of the finished product, if any, and packaging, records shall be maintained. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale.
It should be essential to maintain the record of date, manpower, machine and equipments used and to keep in process record of various shodhana, bhavana, burning and fire and specific grindings in terms of internal use.


Hope Above information is helpful to you...

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