Who certification 112070804014

WHO CERTIFICATION

PREPARED BY:- SANKET . D . PATEL

Q.A SEM-1

GUIDED BY:- MISS. SHREYA GUJARATI ASS. PROFESSOR

CONTENTS

INTRODUCTIONPARTICIPATION IN THE SCHEMETYPES OF CERTIFICATESGUIDELINES 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

APMC College Of Pharmaceutical Education And Research

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 system.


1968: The request for GMPs by member countries was followed by request for certification scheme

1969: WHA (22nd World Health Assembly) recommended ,First version of WHO certification schem. 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 product certificates.


1992: The second revision of the scheme was discussed by the WHO expert committee

Revision included forVeterinary 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 stateInformation on safety and efficacy.


PARTICIPATION IN THE SCHEME

Any member state, which intends to participate in the scheme, should write to the Director general of WHO

of its willingness to participate in the scheme, reservations if any relating to participation name and address of its national drug regulatory authority or other competent authority.

Such notifications are announced in the monthly WHO pharmaceutical newsletter.

National governments can have the information from the division of Drug management and policies, WHO, Switzerland.

A member state participate, only to the control the imports of pharmaceutical products and substances.


TYPES OF CERTIFICATES Three types of certificates can be

requested under this scheme:

A certificate of a pharmaceutical product

A statement of licensing status of pharmaceutical products

A batch certificate of a pharmaceutical product


A). CERTIFICATE OF PHARMACEUTICAL PRODUCTS

It is issued by the exporting country , and use by the competent authority within importing country in two situations: When the product in question is under

consideration for a product license that will authorize its importation and sale.

When administrative action is required to renew, extend, vary, or review such a license.

All requests for certificates should be channeled through the agent in the importing country and the product license holder in the exporting country (“the applicant”)


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 exist 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, and

Retail packaging


The certificate can be issued by the competent authority in the exporting country with the permission of the applicant and or the product-license holder.

The certificate is intended to be incorporated into the product-license application in the importing country.

Once prepared, applicant or agent in importing country transfer it to the requesting authority.

If 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.


In the absence of any specific agreement, each certificate will be prepared exclusively in the working languages of the certifying authority and 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 discretion of the certifying authority and with the permission of the applicant.

The certifying authority is under no obligation to supply additional information.


Example:- certificate for pharmaceutical product

No. of certificateExporting (certifying country): Importing (requesting country):Name and dosage form of the product: Active ingredient and amount per unit dos:


B). STATEMENT OF LICENSING STATUS

This attests only that a license has been issued for a specified product, or products, for use in the exporting country.

It is used 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.


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.

Applicant (name/address):


Name Of Product

Dosage form Active ingredient and

amount per unit dose:

Product-license No. and date of

issue

•Address of certifying authority:

•Name of authorized person: •Telephone/fax numbers: •Signature:•Stamp and date:

C). 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.


This 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.APMC College Of Pharmaceutical Education And Research

Example: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.

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: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


It is hereby certified that the above declarations are correct and that the results of the analyses 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:


GUIDELINES

1. PROVISION AND OBJECTIVES 2. ELIGIBILITY FOR PARTICIPATION3. REQUESTING A CERTIFICATE4. ISSUING A CERTIFICATE5. NOTIFYING AND INVESTIGATING

A QUALITY DEFECT


1.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.


2. ELIGIBILITY FOR PARTICIPATION IN THE SCHEME Any Member State intending to participate in

the Scheme may do so by notifying the Director-General of the WHO, in writing, of:

its willingness to participate in the Scheme; any significant reservations it intends to

observe relating to this participation the name and address of its national drug

regulatory authority or other competent authority.

These notifications will be subsequently announced in the monthly WHO Pharmaceutical Newsletter.


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, for pharmaceutical products, manufacturers and distributors;

Implementation of GMP requirements, recommended by WHO,


effective controls to monitor the quality of pharmaceutical

products registered or manufactured within its country,

Competent inspectorate staff, which can investigate to ensure

that manufacturers conform to these requirements;

administrative capacity to issue the required certificates and

do inquiries in case of complaint.

Each Member State do a process of self-evaluation, to determine,

whether it satisfies these prerequisites.

There is no provision for external inspection or assessment of a

competent national authority or a manufacturing facility .


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 products,

Batch certificate of pharmaceutical products.

All participating countries are encouraged to adopt these formats to facilitate interpretation of certified information.


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.


4. 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, the applicant:

Applies identical standards to the production of all batches of pharmaceutical products manufactured within the facility, including those intended exclusively for export;


Consents to relevant inspection reports being released, in confidence, to the competent authority in the country of import, should the latter so required.

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, 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 manufacturer is an established supplier of the substance in question to manufacturers of finished dosage form licensed for marketing under its jurisdiction.

Whenever a product is purchased through a broker or another intermediary, 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.

Any additional attachment to a certificate submitted by the applicant, should be clearly identified as not forming part of the attestation made by the certifying authority.


Each certificate should identify the importing country and be stamped on each page with the official seal of the certifying authority;

To prevent potential misuse of the scheme

To provide routine authentication of certificates by an independent authority superfluous,

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.


5.NOTIFYING AND INVESTIGATING A QUALITY DEFECT

Each certifying authority inquire, any quality defect reported in a product exported in accordance with the provision 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 latter authority;

The defect, if it appeared after delivery of the product in to the importing country, is not attributable to local conditions


REFERENCES

1. P.P.Sharma, How to practice GMPs,3rd edition , Vandana publication, Delhi,13-41.

2. WHO Certification schemehttp://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/guidelines/en/index.html


http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/guidelines/en/index.html




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