WHO CERTIFICATION SCHEME

PowerPoint Presentation: 

A seminar On who certification schem E PREPARED BY:KAMLESH K . MAKWANA GUIDED BY: Mr. JIGNESH SHAH M.pharm- 1 (Q.A) Assistant professor S.J Thakkar Pharmacy College, Rajkot 1 SJTPC,RAJKOT

CONTENTS:: 

CONTENTS: Introduction Participation in the scheme Types of certificates Guidelines for implementation of who certification scheme- Provision and objectives Eligibility for participation Requesting a certificate Issuing a certificate Notifying and investigating a quality defect References 2 SJTPC,RAJKOT

INTRODUCTION :: 

INTRODUCTION : HISTORY OF WHO: Diplomats met in 1945 to form the United Nations , one of the things they discussed was setting up a global health organization. WHO’s Constitution came into force on 7 April 1948 – a date now celebrated every year as World Health Day. WHO is the directing and coordinating authority for health within the United Nations. 3 SJTPC,RAJKOT

PowerPoint Presentation: 

1968 : The request for GMPs by member countries was followed by request for certification scheme . 1969: WHA (World Health Assembly) recommended , First version of WHO certification scheme . This scheme provided for regular publication of a list of certified manufacturers and for batch certificates from drug regulatory authorities of exporting country. 1975: The first revision of the scheme by WHA .The provision for publication of certified manufacturers replaced by product certificates. 4 SJTPC,RAJKOT CONT…

PowerPoint Presentation: 

1992: The second revision of the scheme was discussed by the WHO expert committee. Revision included for Veterinary products administered to food producing animals. Starting materials for use in dosage forms when these are subjected to control by legislation in the exporting member state and in the importing member state Information on safety and efficacy. 5 SJTPC,RAJKOT CONT…

PowerPoint Presentation: 

SJTPC,RAJKOT 6 The Scheme offers to importing countries information about: a) The status of the pharmaceutical product; b)The status of the manufacturer of the pharmaceutical product; c)The quality of individual batches of the exported pharmaceutical product; d) Product information as approved in the country of export. The certification scheme has now been extended to include certification of: Veterinary products administered to food producing animals. Starting materials for use in dosage forms when these are subjected to control by legislation in the exporting member state and in the importing member state; an information on safety and efficacy.

PARTICIPATION IN THE SCHEME:: 

PARTICIPATION IN THE SCHEME: A large number of member states have agreed to participate in the scheme. Any member state, which intends to participate in the scheme, should write to the Director general of WHO for its willingness to participate in the scheme, reservations if any relating to participation the name and address of its national drug regulatory authority or other competent authority. 7 SJTPC,RAJKOT

CONT..: 

CONT.. Such notifications (participations) are announced in the monthly WHO pharmaceutical newsletter. The WHO intends to publish consolidated list of participants annually in the newsletter. National governments can also have the information from the division of Drug management and policies, WHO, 1211 Geneva 27, Switzerland. A member state participate only to the control the imports of pharmaceutical products and substances. SJTPC,RAJKOT 8

Types of Certificates: 

Types of Certificates WHO-type Certificate Certificate of Pharmaceutical Product (WHO 1975 type) Certificate of a Pharmaceutical Product (WHO 1988 type) Certificate of a Pharmaceutical Product (WHO 1992 type) Statement of Licensing Status (WHO 1992 type) Batch Certificate (WHO-type) SJTPC,RAJKOT 9

(a) Certificate of Pharmaceutical Product (WHO 1975 type): 

(a) Certificate of Pharmaceutical Product (WHO 1975 type) The 1975 version of the WHO-type Certificate of a Pharmaceutical Product is a certificate to be issued by a competent authority (regulatory authority) of the exporting country The certificate combines (1) and (2) below in a single document that the product has been authorized to be placed on the market for use in the country including the number of permit and date of issue, or that the product has not been authorized to be placed on the market for use in the country and the reasons why; that: a) the manufacturing plant in which the product is produced is subject to inspections at suitable intervals; and b) the manufacturer conforms to GMP requirements as recommended by WHO in respect of products to be sold or distributed within the country of origin or to be exported. SJTPC,RAJKOT 10

PowerPoint Presentation: 

SJTPC,RAJKOT 11 (b) Certificate of a Pharmaceutical Product (WHO 1988 type) The 1988 format of the Certificate of a Pharmaceutical Product is similar to the 1975 version, but in addition the competent authority of the exporting country is required to provide copies of the complete text of all labelling and product information which is authorized in the country of origin. (c) Certificate of a Pharmaceutical Product (WHO 1992 type) This is intended for use by the competent authority of an importing country in two situations: a) when the product in question is under consideration for a product license that will authorize its importation and sale; and b) when administrative action is required to renew, extend, vary or review such a license.

PowerPoint Presentation: 

SJTPC,RAJKOT 12 The certificate provides information on the following: whether a product is licensed to be placed on the market, and if not, the reasons why; whether the applicant manufactures the dosage forms, packages and/or labels a finished dosage form manufactured by an independent company. if the manufacturer of the product has been inspected and the periodicity of inspection; if the certificate is provisional, pending technical review; whether the information submitted by the applicant satisfies the certifying authority on all aspects of the manufacture of the product undertaken by another party; states the names of the importing and exporting (certifying) countries.

PowerPoint Presentation: 

SJTPC,RAJKOT 13 ( d) Statement of Licensing Status (WHO 1992 type) This is an attestation issued by a national regulatory authority of an exporting country stating that a license has been issued for a specified product or products for use in the exporting country. It is intended for use by importing agents when considering bids made in response to an international tender and is useful only to facilitate the screening and preparation of information. (e) Batch Certificate (WHO-type) A certificate issued by either the manufacturer or by the competent authority of an exporting country confirming that the quality of a specific batch of the product conforms to specifications approved at the time of issuance of product license by the competent authority in the exporting country. The batch certificate indicates the name, dosage form, batch number, expiry date, storage condition of the product as well as a reference to the Certificate of a Pharmaceutical Product.

GUIDELINES: 

GUIDELINES Provision and objectives Eligibility for participation Requesting a certificate Issuing a certificate Notifying and investigating a quality defect 14 SJTPC,RAJKOT

PROVISION AND OBJECTIVES : 

PROVISION AND OBJECTIVES To assure that manufacturing operations should comply with GMP. The scheme is an administrative mechanism, which requires each participating member state to attest the following to the competent authority of another participating member state : A specific product is authorized to be placed on the market within its jurisdiction The plant in which it is produced is subject to inspection at suitable intervals All submitted information, including labeling, currently authorized in the certifying country. 15 SJTPC,RAJKOT

CONT…: 

CONT… The Scheme, as subsequently amended in 1975 and 1988 , Which is applicable to finished dosage forms , intended for administration to human beings or to food-producing animals. Scheme comprises of internationally recognized and respected standards that all member states are urged to adopt and apply. Scheme also include provision for certification of active ingredients. SJTPC,RAJKOT 16

ELIGIBILITY FOR PARTICIPATION IN THE SCHEME: 

ELIGIBILITY FOR PARTICIPATION IN THE SCHEME Requires an effective licensing system for manufacturer of products and distributors. Implementation of GMPs requirements in consonance with those recommended by the WHO. Effective measures to monitor the quality of pharmaceutical products registered or manufactured within the country; SJTPC,RAJKOT 17

CONT…: 

CONT… They should have Competent inspectorate staff, which can investigate to ensure that manufacturers conform to these requirements. Administrative capacity to issue certificates under the scheme and to institute inquiries in case of complaint and to notify expeditiously both WHO and the competent authority, if any member state known to have imported a specific products under complaint. There is no provision in the scheme under which an external inspection or assessment of a competent national authority or of manufacturing facility can be done . SJTPC,RAJKOT 18

3. REQUESTING A CERTIFICATE : 

3. REQUESTING A CERTIFICATE Three documents can be requested within the scope of the scheme; A certificate of a pharmaceutical product, A statement of licensing status of pharmaceutical product. Batch certificate of pharmaceutical products. All participating countries are encouraged to adopt these formats to facilitate interpretation of certified information. 19 SJTPC,RAJKOT

PowerPoint Presentation: 

A list of addresses of competent national regulatory authorities participating in the scheme, may be obtained from WHO as indicated in the pharmaceutical newsletter. Each participating country in the scheme should issue guidelines to all agents responsible for importing under its jurisdiction, to explain the contribution of certification to the drug regulatory process and the circumstances in which each of three types of documents will be required. 20 SJTPC,RAJKOT

1.CERTIFICATE OF PHARMACEUTICAL PRODUCTS : 

1.CERTIFICATE OF PHARMACEUTICAL PRODUCTS The certificate of a pharmaceutical product, issued by the exporting country, it is mainly used by the competent authority within an importing country in two situations: (1)When the product in question is under consideration for a product license which is necessary for import and sale; (2)When administrative action is required to renew, extend, vary, or review such a license. All requests for certificates should be channelled through the agent in the importing country and the product-license holder or other commercially interested party in the exporting country (“ the applicant”) SJTPC,RAJKOT 21

PowerPoint Presentation: 

SJTPC,RAJKOT 22 The applicant should submit the following information for each product: Brand name, Generic name (International Non-proprietary Name, where such exists). Name and address of manufacturing facility, Formulation (when no product license exists or when the formulation differs from that of the licensed product) Product information for medical professionals and for patients as approved in the exporting country, Labeling on retail and wholesale containers, Retail packaging.

PowerPoint Presentation: 

SJTPC,RAJKOT 23 The certificate can be issued by the competent authority in the exporting country only with the permission of the applicant and, if different than the product-license holder. The certificate should be incorporated into the product-license application in the importing country. Once prepared, it is transmitted to the requesting authority through the applicant. When any doubt arises about the status or validity of a certificate, the competent authority in the importing country should request a copy direct from the certifying authority.

PowerPoint Presentation: 

SJTPC,RAJKOT 24 In the absence of any specific agreement, each certificate will be prepared exclusively in the working languages of the certifying authority. The applicant will be responsible for providing any notarized translation that may be required by the requesting authority. Since the preparation of certificates imposes a significant administrative load on certifying authorities, the service may need to be financed by charges levied upon applicants. Supplementary attestations are obtainable only at the certifying authority and with the permission of the applicant.

PowerPoint Presentation: 

Example -certificate for pharmaceutical product No. of certificate Exporting (certifying country): Importing (requesting country): Name and dosage form of the product: Active ingredient and amount per unit dos: 1.Is the product licensed to be placed on the market for use in the exporting country? If yes, complete box A and if no, compete box B 25 SJTPC,RAJKOT

PowerPoint Presentation: 

A Product-license number: Status of license number: Number of product license and date of issue: Is an approved technical summary appended?(yes/no) Is the attached product information complete and consonant with license? (yes/no/not provided) Applicant for certificate if different from the license holder: B Applicant for certificate: Status of applicant: Why is authorization lacking? (not required/not requested/under consideration/refused) Remarks: 26 SJTPC,RAJKOT

PowerPoint Presentation: 

2. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced? (yes/no/not applicable) If not or not applicable, proceed to question : 2.1. Periodicity of routine inspections (years): 2.2. Has the manufacture of this type of dosage form been inspected? (yes/no) 2.3 Do the facilities and operations conform to GMP as recommended by the World Health Organization? (yes/no/not applicable) 27 SJTPC,RAJKOT

PowerPoint Presentation: 

3. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product : (yes/no) If no, explain: Address of certifying authority: Telephone: Fax: Name of authorized person: Signature Stamp and date 28 SJTPC,RAJKOT

PowerPoint Presentation: 

SJTPC,RAJKOT 29 2.STATEMENT OF LICENSING STATUS: The statement of licensing status of pharmaceutical products attests only that a license has been issued for a specified product, or products, for use in the 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. The importation of any product that is provisionally selected through this procedure should be determined on the basis of a certificate of a pharmaceutical product.

PowerPoint Presentation: 

Example: No. of statement: Exporting (certifying) country: Importing (requesting) country: This statement indicates only whether or not the following products are licensed to be put on the market in the exporting country. 30 Name of product Dosage form Active ingredient and amount per unit dose: Product-license No. and date of issue SJTPC,RAJKOT

PowerPoint Presentation: 

Applicant (name/address): Address of certifying authority: Name of authorized person: Telephone/fax numbers: Signature: Stamp and date: 31 SJTPC,RAJKOT

: 

3.BATCH CERTIFICATE This certificate is issued by the manufacturer and only exceptionally in the case of the vaccines, sera, and certain other biological products, by the competent authority of the exporting country. This is used to accompany and provide an attention concerning the quality and expiry date of a specific batch of product that has already been licensed in the importing country. 32 SJTPC,RAJKOT

PowerPoint Presentation: 

Batch certificate should include the specifications of the final product at the time of batch release and the results of the full analysis. In most circumstance these certificates are issued by the manufacturer to the importing agent, but they must be made available in the course of any inspection made on behalf of the competent national authority. 33 SJTPC,RAJKOT

PowerPoint Presentation: 

Example(batch certi .): 1. No. of Certificate: 2. Importing (requesting) authority: 3. Name of product: Dosage form: Active ingredient and amount per unit dose: Is the composition of the product identical to that registered in the country of export? (yes/no/not applicable) If no: please attach formula (including excipients) of both products. 34 SJTPC,RAJKOT

PowerPoint Presentation: 

4. Product-licence holder(name and address): Product-licence number: Date of issue: Product licence issued by: Product certificate number: 5.1 Batch number: 5.2 Date of manufacture: 5.3 Shelf life (years): 5.4 Contents of container: 5.5 Nature of primary container: 5.6 Nature of secondary container/wrapping: 35 SJTPC,RAJKOT

PowerPoint Presentation: 

5.7 Specific storage conditions: 5.8 Temperature range: 6 Remark: 7. Quality analysis: 7.1 What specifications apply to this dosage form. Either specify the pharmacopoeia or append company specifications. In the case of a product registered in the exporting country, have these company specifications been accepted by the competent authority? (yes/no) 7.2 Does the batch comply with all parts of the above specifications? (yes/no) 7.3 Append certificate of analysis 36 SJTPC,RAJKOT

PowerPoint Presentation: 

It is hereby certified that the above declarations are correct and that the results of the analysis and assays on which they are based will be provided on request to the competent authorities in both the importing and exporting countries. Name and address of authorized person: Telephone no: Fax number: Signature of authorized person: Stamp and date: 37 SJTPC,RAJKOT

PowerPoint Presentation: 

SJTPC,RAJKOT 38 ISSUING A CERTIFICATE The certifying authority should assure the authenticity of the certified data. Certificate should include the statement to confirm whether or not the document is issued in the format recommended by WHO. 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 standards to the production of all batches of pharmaceutical products manufactured within the facility. 2. Relevant inspections are carried out and report of inspection are being released, in confidence, to the competent authority in the country of import

PowerPoint Presentation: 

SJTPC,RAJKOT 39 When the applicant is not the manufacturer of the finished dosage form, satisfy itself described as above. GMP as recommended by WHO assigns to the manufacturer of the finished dosage form responsibility for assuring the quality of active ingredients be identified in the product license, but the competent authority may have no power to inspect them. Certifying authority may be able to attest that the manufacturers is an established supplier of the substance in question to manufacturers of finished dosage form licensed for marketing under its jurisdiction. CONT…

PowerPoint Presentation: 

SJTPC,RAJKOT 40 Whenever a product is purchased through a broker or another intermediary, or when more than one set of premises has been involved in the manufacture and packaging of a product, the certifying authority should consider that those aspects of the manufacture of the product for which the applicant is not directly responsible have been undertaken in compliance with GMP as recommended by WHO. The certifying authority should officially stamp and date all copies of product information submitted to it in support of an application for a certificate

PowerPoint Presentation: 

SJTPC,RAJKOT 41 Any additional attachment to a certificate submitted by the applicant, such as price lists of products for which bids are offered, should be clearly identified. Each certificate should identify the importing country and be stamped on each page with the official seal of the certifying authority; To avoid potential abuse of the scheme. To render routine authentication of certificates by an independent authority, To enable the certifying authority to maintain comprehensive records of countries to which specific products have been exported. An identical copy, clearly marked as duplicate, should be forward by the certifying authority on demand direct to the authority in the importing country.

NOTIFICATION AND INVESTIGATING A QUALITY DEFECT: 

NOTIFICATION AND INVESTIGATING A QUALITY DEFECT Each certifying authority inquiries about any quality defect reported in a product exported according to the provisions of the scheme, on the understanding that: The complaint is transmitted, together with the relevant facts, through the competent authority in the importing country; The complaint is considered to be of a serious nature by the importing authority; The defect, if it appeared after delivery of the product into the importing country, is not attributable to local conditions. SJTPC,RAJKOT 42

PowerPoint Presentation: 

SJTPC,RAJKOT 43 In the case of obvious doubt, a participating national authority may request WHO to assist in identifying an independent quality control laboratory to carry out tests for the purposes of quality control. Each certifying authority undertakes to inform WHO and, as far is possible, all competent national authorities, of any serious hazard newly associated with a product exported under the provisions of the scheme or of any criminal abuse of the scheme directed, in particular, to the export of the falsely labelled, spurious or substandard pharmaceutical products. WHO stands prepared to offer advice in implementing any aspect of the scheme or in resolving a complaint, but it cannot be a part to any result.

PowerPoint Presentation: 

SJTPC,RAJKOT 44 Other Certificates (non WHO-type) Free Sale Certificate GMP Certificate Analytical Batch Certificate

PowerPoint Presentation: 

SJTPC,RAJKOT 45 Free Sale Certificate A certificate issued by a national regulatory authority of an exporting country based on national legislation confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country. b) GMP Certificate A certificate issued by a national regulatory authority of an exporting country confirming that the manufacturer complies with GMP requirements.

PowerPoint Presentation: 

SJTPC,RAJKOT 46 c) Analytical Batch Certificate A certificate issued by a manufacturer confirming that the quality of a specific batch corresponds to the specifications for the product at the time when the batch was released. It contains results of analytical tests but does not mention the relevant Certificate of a Pharmaceutical Product issued by the regulatory authority of the exporting country as recommended by WHO.

Previously asked Questions: 

Previously asked Questions Write a note on WHO Certification Scheme Explain briefly the important elements of the WHO Certification scheme. SJTPC,RAJKOT 47

References:-: 

References:- 1) P.P.Sharma, How to practice GMPs,3rd edition , Vandana publication, Delhi, Page no:13-41 WHO Expert Committee On Specification for Pharmaceutical Preparation,37 th report by WHO www.WHO.INT/medicines/areas/certification.html SJTPC,RAJKOT 48

PowerPoint Presentation: 

THANK YOU 49 SJTPC,RAJKOT THANK YOU