WHO – GMP Certificate registration

Procedure for Obtaining a WHO – GMP Certificate for the Manufacturing Unit in India:

• Obtaining Login credentials: To obtain a WHO–GMP Certificate, the applicant must first register in an online portal and create a Login ID and Password.
• Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
• Fees: The applicant must pay the required fees online by the requirements as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945 or The Medical Devices Rules, 2017.
• Inspection: Following the submission of documentation joint inspection shall be carried out in accordance with the latest WHO GMP guidelines
• Issue of Drug License: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant or reject the license.

Pre - Requisites / Documents required for Loan License for Manufacturing:

• Manufacturing License: The applicant must have a valid manufacturing license
• Covering Letter: A Covering letter on the letterhead stating the purpose of the application.
• Competent Technical Staff/ Registered Pharmacist Person: The List of competent technical staff with their qualifications, registration, experience, previous FDA approvals, and so on.
• Firms Constitution Documents: Photo ID / Partnership Deed & ROF registration receipt / Certificate of Incorporation / Trust Registration / HUF Deed / Society Registration depending on the type of constitution
• Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone Number, and Email id.
• ID Proof: Pan card and Aadhar card of proprietor/partners/directors.
• Agreement: Sale Agreement or Registered Rent Agreement
• Others: The FDA department may require additional documents depending on the place and nature of business.

Obtaining a WHO – GMP Certificate for the Manufacturing Unit can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the license. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.

You can apply for a WHO – GMP Certificate / Renewal of Certificate / Product Addition / Duplicate License or Surrender of License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com