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GMP Certifications Guidelines Under WHO - GMP Scheme

Introductory Note :

The first World Health Organization (WHO) draft text on Good Manufacturing practices (GMP) was prepared at the request of Twentieth World Health Assembly in 1967 by a Group of Consultants. The text was discussed by the WHO Expert Committee on specification for Pharmaceutical Preparations in 1968. When the World Health Assembly recommended the first version of the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce in 1969, it accepted at the same time, the GMP text as an integral part of the Scheme. The revised versions of both the certification scheme and GMP text was adopted in 1975. Since then the certification scheme has been extended to include certification of:

- Veterinary products administered to food producing animals.
- Starting materials for use in dosage form.
- Information on safety and efficacy.

The Director General of WHO invited the member States to participate in the Scheme. The Drugs Controller of India informed WHO that India had decided to participate in the certification scheme. The issue was discussed in the 20th Meeting of Drugs Consultative Committee held at New Delhi on 4th & 5th July 1978. The silent features of WHO Certification Scheme were discussed and it was decided that the inspection of firms intending export of drugs be thoroughly inspected and ensured that they observe the necessary control on quality during and after manufacture of pharmaceutical products and follow Good Manufacturing Practices before a certificate is issue in their favour.

It was also decided to follow following guidelines-

(1) Joint Inspection of manufacturing firms by senior officers of the State Drugs Control Organization and Zonal Officer from Central Drugs Standard Control Organization should be carried out before issuing certificates under the Scheme.

(2) It should be ensured that the firm is observing – Good Manufacturing Practices and have checks on controls exercised.

Since the Licensing Authority for the State of Maharashtra was the Commissioner, FDA, he was issuing the certificates under the WHO certification scheme till 1990. The powers of the Licensing were decentralized, hence, 1990 onwards the Divisional Joint Commissioners issued the said Certificates. From 1998 onwards the certificates were issued by the Joint Commissioner (H.Q.) Mumbai, as single certifying authority was required by WHO. Since July 2003, Commissioner, Food and Drug Administration, Maharashtra State authorized Joint Commissioner (Law) to sign and issue the certificate/s under WHO certification scheme.

In 1988, the guidelines for grant of GMP Certificate as per WHO guidelines were issued. Since many of the provisions and guidelines by the WHO have been upgraded, it revised guidelines on the subject were issued by the Commissioner, FDA vide circular no. WHO GMP/SaulkvaaZ /1083-03/11 dated 17 November, 2003.

Whereas, there have been revision in the WHO – GMP guidelines and the procedures to be followed in Certifying the unit, the existing guidelines needed certain modifications. Henceforth the revised guidelines for the issue of Certification under WHO-GMP guidelines will be as follows:

PROCEDURE TO BE FOLLOWED IN THE STATE OF MAHARASHTRA

(A) RECEIPT OF APPLICATIONS

1. The applicant will make an application for Certification under WHO – GMP Guidelines Scheme on the letter head of the company, along with the Site Master File to the office of the Assistant Commissioner with a copy to the Licensing Authority or to the Office of the Joint Commissioner depending on the location of the factory along with the requisite inspection fees. The applicant should attach the following enclosures along with the said application.

a. An undertaking that the manufacturing site is ready for inspection at the time of the application.

b. The details of the sections with list of products to be covered under certification.

c. Photocopies of licences and the list of approved products.

2. Second copy of the application along with its enclosures should be submitted forthwith by the applicant to the Office of the Deputy Drugs Controller (I), C.D.S.C.O., (West Zone) Mumbai with a request letter to depute the officers in coordination with the District Office of the State Licensing Authority for the Joint Inspection within 15 days.

Note: The incomplete applications or applicant whose site is not ready for Inspection shall not be accepted. To confirm that the site is ready in all respects the applicant should be asked to come prepared with all evidences (audio – visual, PowerPoint presentation, documents, etc.) and personally explain the preparedness for inspection at the time of accepting application itself.

(B)INSPECTIONS.

1. The District Office shall sent a letter on next working day with the request for the Joint Inspection, with the tentative dates of Inspection, to the Office of the Deputy Drugs Controller (I), C.D.S.C.O., (West Zone) Mumbai under intimation to the Licensing Authority and Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai.

2. The joint inspection shall be carried out in accordance with the latest WHO GMP Guidelines preferably within 15 days from the receipt of the application.

3. The inspection team shall prepare the inspection report in the prescribed Proforma at the time of the inspection and the copy of the same shall be given to the applicant.

(C) RECOMMENDATIONS

1. The detailed inspection report in the prescribed Proforma shall be submitted forthwith to the Assistant Commissioner with the recommendations.

2. The Assistant Commissioner shall submit the said report with his comments and
recommendations to the Licensing Authority within 7 days.

3. The Licensing Authority shall decide on the said application preferably within 7 working days and compliance of observations, if need be, shall be informed to the applicant within 2 working days. The period given for the compliance to the applicant shall not exceed 1 month from the date of information.

4. After receipt of the inspection report with recommendation and compliance, if any, the Licensing Authority shall decide on the said application preferably within 2 working days. If the Licensing Authority recommends for the Grant of the Certification under the WHO – GMP Guidelines Scheme, he shall forward the said application forthwith to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai along with the copies of the application, inspection report in Original, signed copy of the list of products for which the certificate is to be granted and other necessary documents.

4. In case of rejection of the application the Joint Commissioner of the Division shall inform the applicant with the reasons thereof, immediately with the intimation to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai.

5. The Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai, shall decide on the said application within 15 working days from the receipt of the said application.

6. The said application for the certification may be disposed off preferably within the period of 2 months from the date of Joint Inspection.

(D) VARIOUS CERTIFICATES TO BE ISSUED UNDER THE SAID SCHEME

The office of the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai i.e. WHO- GMP Cell at Head Quarters of FDA, shall issue, following certificates to the manufacturers on their request.

1. Certificate of Pharmaceutical Product(s).
2. Model Statement of Licensing Status of Pharmaceutical Product(s).
3. Unit WHO GMP Certificate along with the list of products for which Certificate of Pharmaceutical Products have been granted.

(E) FEES

1. A fee of Rs 5000/- per section of the own manufacturer, as specified in the Schedule M of the Act, as an inspection fee, to be deposited at the district office at the location of the manufacturing site. In case of application by a Loan Licensee, a fee of Rs 2000/- per section of the own manufacturer, as specified in the Schedule M of the Act, as an inspection fee, to be deposited at the district office at the location of the manufacturing site

2. A fee of Rs. 500/- per copy of Certificate of Pharmaceutical Products shall be paid by the applicant for a specific single country for the product, which the Unit WHO GMP Certificate or COPP has been already granted.

3. A fee of Rs. 1000/- per copy of Certificate of Pharmaceutical Products shall be paid by the applicant for multiple countries or country annexure or any other annexure such as excipients, formula, etc.

4. A fee of Rs. 1000/- per copy of Certificate of Pharmaceutical Products without annexure shall be paid by the applicant for a product for which the Unit WHO GMP Certificate or COPP has not been previously granted and have applied with the data such as Validation, Stability, etc. Additional Rs 500/-shall be paid by the applicant in case the said certificate is required with the annexure.

5. A fee of Rs. 1000/- per list of ten (10) products is to be paid by the applicant for Model Statement of Licensing Status of Pharmaceutical Product(s).

6. A fee of Rs. 1000/- per list of ten (10) products is to be paid by the applicant for grant of Unit WHO - GMP Certificate.

(F) ISSUE OF CERTIFICATES UNDER THE SCHEME

1. Joint Commissioner (Law) is authorized by Commissioner, Food & Drug Administration, Maharashtra State, to sign & issue the certificates under the WHO-GMP certification scheme.

2. After approval from the Joint Commissioner (Law), the Certificate of Pharmaceutical Products or other certificates under Scheme shall be issued in the prescribed format to the manufacturer.

3. The validity of certificates shall be two years from the date of grant of the Certificate.

(G) COPPs FOR ADDITIONAL PRODUCTS AFTER GRANT OF WHO-GMP CERTIFICATE

A manufacturer may apply for grant of Certificate of Pharmaceutical Products for additional product(s) to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai. Such application shall be accompanied by the following documents.

1. Stability data of the product as per WHO GMP guidelines.
2. Process validation of the product as per WHO GMP Guidelines.
3. In cases where there are no WHO GMP guidelines on stability studies, other international guidelines, such as ICH guidelines shall be applicable.

(H) APPROVAL OF ADDITIONAL SECTION / CATEGORY OF PHARMACEUTICAL PRODUCTS

The proposal of approval of additional category of product whose section was not approved in earlier proposal has to be considered as a fresh proposal and is to be approved after carrying out joint inspection and by following procedure for grant of WHO-GMP Certificate.

(I) GRANT OF WHO-GMP CERTIFICATES TO LOAN LICENSEE

1. The application for proposal by loan licensee shall be made only at the time of processing the proposal of the own manufacturer or after the grant of such certificate to the own licensee.

2. Such applications may be directly submitted to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai, to avoid the delay in the processing.

3. The loan licensee’s proposal shall be considered only for the category(s)/section(s) of formulations / API as that has been recommended/granted for the own licensee.

4. Wherever required the application shall accompany the data about stability data, process validation as per WHO GMP guidelines.

5. The date of validity of certificate of Pharmaceutical Product issued to the loan licensee will be the same as that assigned to the own manufacturer.

6. A copy of the contract should be submitted between the contract giver (Loan Licensee) and the contract acceptor (own license) which specifies their respective responsibilities relating to manufacture, quality control, quality assurance, stability, procedures to be followed, etc. pertaining to the products. This contract should be as per the conditions laid under WHO GMP guidelines.

7. The fees to be paid in case of such applications will be same as prescribed for the own licensee holding the WHO GMP Certificate.

8. If the Loan Licensee applies for the fresh certification at the time of the extended period of Validity of the Own Licensee’s Certification, then it shall be supported with the proper justification for the same.

(J) INFORMATION ABOUT THE STATUS TO THE JOINT COMMISSIONER (LAW)

The information about the following may be sent to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai periodically by the offices of Assistant Commissioner and Divisional Joint Commissioners.

1. The details of the applications received / pending for the grant of WHO-GMP Certificates
2. The details of the NSQ reports received and actions thereof pertaining to the WHO – GMP Certificate holders.
3. The details of the action such as licence / product suspension, cancellation, etc. taken on the GMP – GMP Certificate holders.

(K) EXTENSION OF VALIDITY OF WHO-GMP CERTIFICATE (COPP)

The validity of Certificate of Pharmaceutical product shall be for a period of two years. If after the expiry of the validity of the said WHO GMP Certificate the licensee wants the fresh certificate, the application for the same as prescribed above in (A) shall be made at least 2 months prior to the expiry of the said certificate. If the said application is pending for Joint Inspection, the certificate holder may apply for the extension of the validity for the period of 6 months of the certificate already granted directly to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai. In order to avoid the hardships to the manufacturer for registration/export of the products and participation in international/Local tenders, due to delay in conduct of Joint Inspection the extension to the validity by six months may be granted under following conditions.

1. The manufacturer shall submit the fresh proposal to respective office for grant of WHO GMP Certificate (COPP) 2 months before expiry of validity of earlier certificates of Pharmaceutical Products as per the procedure prescribed in above (A).

2. The licensee shall submit the proposal to the Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai along with the proof of the submission of the application as stated above with the photocopy of the receipt of the inspection fees paid.

3. The extension period shall be for the period of six months from the date of expiry of the certificate previously granted.

4. In case where the inspection is pending for the period more than 6 months the extension period may further be extended to the period of 6 months. But in any case the said period will not extend to more than 12 months from the validity of the initial certificate, with the intimation to the Office of the Deputy Drugs Controller (I), C.D.S.C.O., (West Zone) Mumbai for arranging immediate inspection in the said case.

(L) WITHDRAWL / SUSPENSION / CANCELLATION OF THE CERTIFICATE ISSUED UNDER THE SCHEME

The Certifying Authority i.e. the Joint Commissioner (Law), FDA, Mumbai may withdraw / suspend / cancel the certificate or the COPP issued to the applicant in case of following circumstances.

1. In case of any serious violations of WHO-GMP guidelines.

2. Any action such as product licences or complete licence suspension / cancellation by the Licensing Authority under Drugs and Cosmetics Act and Rules there under.

3. The Certifying Authority may withhold or delay in grant of GMP Certificates until appropriate measures have been taken by the manufacturer which have been confirmed by re-inspection.

4. In case the product is declared as not of standard quality, depending on the nature of the defect the COPP may be withdrawn or may be rejected or delayed till satisfactory compliance and recommendation from the Licensing Authority.

 

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