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Manufacturing Batch Record for Cosmetics

I. Particulars to be shown in the manufacturing records:  (1) Serial number.  (2) Name of the product.  (3) Lot or Batch size.  (4) Lot or Batch number.  (5) Date of commencement of manufacture and date when manufacture was completed.  (6) Names of all ingredients, quantities required for the lot/batch size, quantities actually used.  (7) Control reference numbers in respect of raw materials used in formulation.  (8) Reference to analytical report numbers or unique code.  (9) Actual production and packing particulars indicating the size and quantity of finished packings.  (10) Date of release of finished packing for distribution or sale.  (11) Signature of the expert staff responsible for the manufacture.  II. Records of raw materials: Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of r

List of Documents for Grant of wholesale drug license

Grant of Wholesale Drug License:

1. Application in Statutory form.

2. License Fee/Challan.

3. Declaration (Notarised affidavit) for new drug sale license in prescribed format by applicant (proprietor/Partners/Director/Authorised Signatory/Power of attorney).

4. Residential certificate, Voter ID, Aadhar card for proof of residential address (permanent).

5. Proof of educational qualification of applicant.

6. Proof of date of birth of applicant.

7. Government document with photo for identification.

8. Four (4) passport size colored photo of applicant.

9. Partnership deed in case of partnership firm/ Article of association, Memorandum of association, List of Directors resolution of Board of directors/Power of attorney (In case of a company).

10. Affidavit in prescribed format regarding character by applicant/character certificate of applicant issued by competent authority.

11. Plan of the proposed premises indicating the carpet area (specifying length and breadth in meters and area in square meter) and boundary with signature of building owner and the applicant and its route chart.

12. Legal document showing the proof of ownership of the building owner with updated property tax receipt for the premise to be licensed.

13. If the proposed premise is on rental basis, rent agreement on India Non Judicial Stamp with updated property tax pay receipt.

14. Purchase receipt of refrigerator with make and capacity.

i) If competent person is registered pharmacist following documents are required:
  • Affidavit in prescribed format regarding consent and appointment of registered pharmacist.
  • Registration certificate and up to date renewal of registration of Registered Pharmacist issued by Bihar State Pharmacy Council, Patna.
  • Four (4) passport size colored photo of registered pharmacist.

ii) If competent person is experienced person, following documents are required: 
  • Affidavit in prescribed format regarding consent and appointment of competent person. 
  • Educational qualification certificate from a recognized university. 
  • Experience certificate of one year after passing degree examination from licensed wholesale drug premises. 
iii. Photocopy of license certificate and updated renewal certificate of experience certificate issuing whole sale drug premises.

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