Maharashtra - Apply for GMP Certificate (Good Manufacturing Practice)

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Procedure

Good manufacturing practices or GMP certification is a mechanism for ensuring the quality of products maintained or not as per the set guidelines. If you are a manufacturer or processer of pharmaceuticals, bulk drug, food processer then you need to get GMP certification.

Apply In-Person:

1. Applicant shall approach the office of the respective range / district / zonal drugs control under whose dominion the applicant is operating.
2. Link for contact details: link roll over to the desired blinker to get the contact details.
3. Go to the respective office and consult with the designated authority to know the updated applying procedure, if any. Please collect the application form or write on a plain A4 sheet as advised.
4. Applicant shall get all the required documents as advised. If there is a shortfall in document requirement, the application won’t be processed.
5. Complete the application form. Attach all the documents as per our “Required Documents” section and submit it to the designated authority in triplicate.
6. Authorities will check the submitted application and document set. If all are in place, the application will be accepted with applicable fees as applicable.
7. After receiving the application, authorities will check the application set and if found complete in all respects, the authority will allot a unique registration number for the correct and complete application in the order of their receipt and assess the inspection fees and other charges.
8. The fee can be made through treasury challan/demand draft (DD)/bank draft/pay order/cash as applicable to the authority or at the respective fee counter as advised.
9. Once the fee is paid, the authority will make appropriate entries in the application. Authorities will register these applications in the manual record or electronically using computer.
10. Applicant will be provided with receipt for payment of fees and attested photocopy of the application as an acknowledgement for the receipt of the application.
11. Please collect it and keep it safe for future reference.
12. Authority will attach a separate checklist to the application to keep a track of the processing of application for GMP certification. This application will be forwarded to the designate authority for further processing.
13. ”SMS” triggered update on application status will be sent to the applicant’s mobile.
14. Applicant will get notification about the tentative date for joint inspection from the department.
15. On the scheduled date, the joint inspection team will visit the premises. The joint inspection shall be carried out in accordance with the latest WHO GMP Guidelines as published time to time in various WHO-TRS.
16. The joint inspection team as far as possible shall prepare the inspection report in the prescribed format at the time of the inspection and the copy of the same shall be given to the applicant.
17. This joint recommendation report will be forwarded to the concerned drug inspector – FDA or the designated authority for their recommendation.
18. From here, this joint report with recommendation as stated above will reach the respective assistant commissioner or the designated authority for their comments.
19. After the comments this application along with joint inspection report, compliance report, recommendation and comments will reach certifying authority for approval.
20. The certifying authority (i.e. the Joint Commissioner (headquarter), FDA or the designated authority as per respective state norms) shall decide on the said application.
21. The status, viz. Approval or Rejection if any will be conveyed to the applicant through an SMS or through email or as per applicable norms.
22. If approved, the certificate will be hand delivered or sent through post to the address mentioned while applying or issued as per applicable norms.
    

Apply Online

1. Go to the online portal. Link for online portal: link
2. In the home page please click “REGISTRATION” option provided on the left part of the screen under “FOOD AND DRUG ADMINISTRATION” to reach a new page.
3. In the ”Registration Form for Manufacturer” page, user shall fill the prompted details as appropriate. Please upload applicable documents using the appropriate prompts.
4. Please enter the captcha at the prompted space and click “Proceed” button to generate and display the unique user ID.
5. The same will be sent your mobile number and email ID registered while applying.
6. With login credentials on hand, please go back to the home page and click “MANUFACTURER LOGIN” option provided on the left part of the screen under “FOOD AND DRUG ADMINISTRATION” to reach a new page.
7. In the new page, please enter the “User ID” at the prompted space and click “Proceed” button to reach a new page.
8. Please select “New Application” option and choose “WHO-GMP Application” to get a new screen.
9. Here, please select “New Application” and select certificate type from the dropdown list.
10. Applicant will get a list of products. Please select the product for which the said certificate is required.
11. As per the above selection, applicant will be provided with prompt to upload applicable file. Please complete uploading files.
12. Read the undertaking and declaration. Please click the checkbox for declaration and then click on “Proceed” button.
13. A preview of the entered details for certification will be provided. If all are ok, then use the applicable button to proceed for making payment.
14. Please click on “+”. The amount will be calculated by the system as per the fee structure notified by FDA and amount will be displayed. Please use the “Make Payment” option to get online payment page. Please complete the payment prompt as applicable and use the payment gateway as appropriate to complete the online payment.
15. After making payment Click on “PAY & CONFIRM”. New window will open. Please enter the details of payment generated by online payment.
16. Agree with the responsibility statement and then confirm the application by clicking on “CONFIRM”. Now the application is submitted online.
17. Applicant shall save the system generated acknowledgement for the online submission of application.
18. Please save it for future reference.
19. This application will be processed further.
20. ”SMS” triggered update on application status will be sent to the applicant’s mobile. Also, status of the application can be viewed by logging in and going to the new application.
21. Please follow department guidelines and notification to get the certificate.
    

Note:

• The parameter and regulations for the grant of this certificate is not same across India. It is advised, that applicant shall consult their local drug control authority to get advice on…
  • Any updated rules and regulations in issuance of this certificate.
  • Update on drugs that were included in the list for which GMP certificate is not permitted.
  • The fee payment for this certificate is accepted in different formats like challan/DD/cheque/cash as applicable. Applicants are advised to take the consultation with the respective drug control authority for your area to prepare fees requirement.
    

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Required Documents

• Application form
• Covering letter addressed to the director of drugs control or as per advised authority, along with Rupees.2/- court fee stamp for each licence
• Demand draft for the advised amount
• Authorization of the signatory of the application form as per requirement
• Copy of manufacturing licence
• List of approved products
• List of technical staff and their bio-data
• List of equipment and instruments
• Manufacturing plant layout design
• Company PAN card
• Record related to quality measures adopted by the business
• Internal audit documents
• Aadhaar card of directors
• Self-declaration
  

Note:Apart from the above listed documents, authorities may ask for additional information or document. Please provide them for smooth processing.

Office Locations & Contacts

Food and Drug Administration,
Survey No. 341, 2nd Floor,
Bandra Kurla Complex Opposite Reserve Bank Of India,
Bandra East, Mumbai, Maharashtra 400051
Phone: +1800 222 365
Contact details: Link

Central Drugs Standard Control Organization,
Ministry of Health and Family Welfare, Directorate General of Health Services,
Government of India FDA Bhavan, ITO, Kotla Road,
New Delhi - 110002, India.
Phone: +91-11-23216367(CDSCO)/ 23236975
Fax: +91-11-23236973
E-mail: [email protected]
Contact link

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Eligibility

• Any person/company/partnership firm/LLP can apply for this license.
• Applicant (company) having competent technical staff on roll are eligible to apply.
• Those who are involved in manufacturing or process medicine/pharmaceuticals, food products, medical devices are eligible to apply.
• Manufacturer or a formulator with a valid licence of manufacture, for sale or for distribution of drugs is eligible to apply.
  

Fees

• Applicant shall pay the applicable Inspection charges and other charges as authorities quote.
• Please refer page number 13 for fee details: link AND link
  

Validity

The validity of the certificate shall be for two years from the date of grant of the Certificate or as per the period mentioned on the certificate.

Documents to Use

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Sample Documents

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Processing Time

The whole process can be completed within 3 months from the date of acceptance of the application.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external
websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe,
myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M%22 Video ID is "Y0US7oR_t3M".

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Instructions

• Please follow the below guidelines for GMP certification.
  • Establish good written procedure.
  • Validate the process.
  • Facility design from start to end.
  • Maintenance of records.
  • Trained and skilled staff.
  • Maintain good hygiene.
  • Proper maintenance of production facility and equipment.
  • Performing regular audit.
• Don’t forget to take all the originals of the document along with copy for applying.
• Ensure that application is complete before submission.
  

Required Information

• Name of the company
• Address of the company
• Names of the drugs
• Date of application
• email ID
• Mobile number
• Company letter head
  

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Need for the Document

• Through GMP certification. It is ensured that the products are safe, efficient and of good quality. “Products” here refers to Medical/pharmaceutical, Food, medical devices etc.
• The certification helps in ensuring maintenance of the best level of hygiene and quality of the products, which further helps in increasing the confidence of customers in the quality of the products.
• GMP is required…
  • To reduce malpractice in production/formulation of products.
  • To access the quality of products.
  • To minimize use of toxic ingredients.
• GMP helps in attaining health and safety of the public.
• For medical product manufacturing, GMP certificate is necessary to make sure that there is no danger to safety and health of patients.
  

Information which might help

• GMP certification increases worth and business value.
• GMP certification enhances company reputation in international market for doing business.
  

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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