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WHO CERTIFICATION SCHEME AND NABL GUIDE LINES

WHO CERTIFICATION SCHEME AND NABL GUIDE LINES. Constitution.

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WHO CERTIFICATION SCHEME AND NABL GUIDE LINES

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  1. WHO CERTIFICATION SCHEME AND NABL GUIDE LINES

  2. Constitution • The WHO's constitution states that its objective is the attainment of the highest possible level of health by all the people. Its major task is to combat disease, especially key infectious diseases, and to promote the general health of the people of the world. • The World Health Organization (WHO) is one of the original agencies of the United Nations, its constitution formally coming into force on the first World Health Day, (April 7, 1948).

  3. WHO CERTIFICATION SCHEME • The Scheme, as subsequently amended in 1975 and 1988 , by resolutions WHA28.65 and WHA41.18, is applicable to finished dosage forms of pharmaceutical products intended for administration to human beings or to food-producing animals. • The Scheme is an administrative instrument that requires eachparticipating Member State, to attest to the competent authority of another participating Member State that:

  4. the plant in which it is produced is subject to inspections at suitable intervals to establish that the manufacturer conforms to GMP as recommended by WHO and • all submitted product information, including labeling, is currently authorized in the certifying country.

  5. Eligibility for Participation • Any Member State intending to participate in the Scheme may do so by notifying the Director-General of the World Health Organization, in writing of: • its willingness to participate in the Scheme. • any significant reservations it intends to observe relating to this participation and • the name and address of its national drug regulatory authority or other competent authority. • A Member State may opt to participate solely to control the import of pharmaceutical products and active substances. This intention should be stated explicitly in its notification to the World Health Organization.

  6. A Member State intending to use the Scheme to support the export of pharmaceutical products should first satisfy itself that it possesses: • an effective national licensing system, not only for pharmaceutical products, but also for the responsible manufacturers and distributors. • GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products are required to conform. • effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country, including access to an independent quality control laboratory.

  7. Requesting a Certificate • Three documents can be requested within the scope of the scheme: • A certificate of a pharmaceutical product (product certificate) • A statement of licensing status of pharmaceutical product(s) • A batch certificate of a pharmaceutical product • When manufacture takes place in a country other than that from which the product certificate is issued, an attestation relevant to compliance of the manufacture with GMP may still be provided (as an attachment to the product certificate) on the basis of inspections undertaken for registration purposes.

  8. Certificate of a pharmaceutical product The applicant should submit the following information for each product to the authority issuing the certificate: • Name and Dosage form of product • Name and Amount of active ingredient(s) per unit dose (International Nonproprietary Name(s) where such exist(s)), • Name and Address of product license holder and/or manufacturing facility, • Formula (complete composition including all excipients; also particularly when no product license exists or when the formulation differs from that of the licensed product), • Product information for health professionals and for the public (patient information leaflets) as approved in the exporting country,

  9. In India, certificate for pharmaceutical product under WHO certification scheme is issued by the state licensing authorities in coordination with the staff of central drug standard control organization (CDSCO),an organization of central government under the control of drug controller general(India). Statement of licensing status This attests only that a license has been issued for a specified product, or products for use in exporting country. It is intended for use by importing agents when considering bids made in response to an international tender, in which case it should be requested by the agent as a condition of bidding.

  10. Batch certificate • A batch certificate of a pharmaceutical product refers to an individual batch of a pharmaceutical product and is a vital instrument in drug procurement. The provision of a Batch certificate is usually a mandatory element in tender and procurement documents. • The batch certificate should provide an attestation concerning the quality and expiry date of a specific batch. • The Batch certificate should include the specifications of a final product at the time of batch release and the results of a full analysis undertaken on the batch in question .

  11. Issuing a certificate • Certificates does not bear the WHO emblem, but a statement should always be included to confirm whether or not the document is issued in the format recommended by WHO. • When the applicant is not the manufacturer of the finished dosage form, the certifying authority should similarly satisfy itself in so far as it has authority to inspect the records and relevant activities of the applicant.

  12. When the applicant is the manufacturer of the finished dosage form, the certifying authority should satisfy itself, before attesting compliance with GMP, that the applicant: • applies identical GMP standards to the production of all batches of pharmaceutical products manufactured within the facility, including those destined exclusively for export. • consents, in the event of identification of a quality defect consonant with the criteria to relevant inspection reports being released, in confidence, to the competent authority in the country of import, should the latter so require. • GMP as recommended by WHO assigns to the manufacturer of the finished dosage form responsibility for assuring the quality of active ingredients.

  13. NABL GUIDELINES • National Accreditation Board for Testing and Calibration Laboratories under Government of India, Deptt. Of Science and Technology is a national accreditation body to grant accreditation to testing and calibration laboratories. • NABL has established its accreditation system in accordance with ISO/IEC 17011, which is followed internationally. • Accreditation body in accordance with international criteria has many advantages: • Potential increase in business due to enhanced customer confidence and satisfaction.

  14. Increase of confidence in Testing / Calibration data and personnel performing work. • Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories. • Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories • Minimizes the chances of re-testing and hence reduces chances of additional financial burden and time delays.

  15. The scope of accreditation covers the identified fields of testing and 5 fields of calibration as shown below: Testing laboratoriesCalibration laboratories Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Photometry Radiological Thermal

  16. Process of Accreditation:

  17. Stage I • Laboratory can apply either for all or part of their testing / calibration facilities. Formats NABL151,NABL152 & NABL 153 are to be used by Testing, Calibration & Medical Laboratories respectively for applying to NABL for accreditation. • Laboratories are required to submit three sets of duly filled in application forms for each field of testing / calibration along with two sets of Quality Manual and Application Fees. • NABL Secretariat on receipt of application will issue acknowledgement to the laboratory.

  18. NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any. The laboratory shall submit Corrective Action Report. • After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organised by NABL. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.

  19. Stage II • NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried by Lead Assessor at the laboratory sites. • A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit. • The laboratory shall submit Corrective Action Report to NABL Secretariat. • After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organised by NABL.

  20. Stage III • NABL Secretariat shall organize the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and for that purpose appoint an assessment team. • The Assessment Team shall comprise of a Lead Assessor and other Technical Assessor(s) in the relevant fields depending upon the scope to be assessed. • The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to NABL Secretariat. • Laboratory shall take necessary corrective action on the remaining Non-Conformance(s) / other concerns and shall submit a report to NABL within a maximum period of 2 months.

  21. Stage IV • Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL requirements as well as commensurate with the claims made by the laboratory in its application. • Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee. • Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat. • Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL.

  22. Whenever possible NABL will depute its own technical personnel to be present at the time of assessment as Coordinator and NABL Observer. Stage V • Accreditation to a laboratory shall be valid for a period of 3 years and NABL shall conduct periodical Surveillance of the laboratory at intervals of one year. • Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.

  23. REFERENCES • How to practice GMPs. A guide for CGMP compliance along with PAT and HACCP 5th edition Pg.no:21-25 • Quantitative Analysis of drugs in Pharmaceutical formulations 3rd edition • www.nabl-india.org/

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