WHO Certification Scheme Guidelines

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

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 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.


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 certificate
 Exporting (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 Product-license
ingredient and No. and date of
amount per unit issue
dose:

•Address of certifying authority:

•Name of authorized person:

•Telephone/fax numbers:
•Signature:
•Stamp and date: APMC College Of Pharmaceutical Education And Research

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.


 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 PARTICIPATION
3. REQUESTING A CERTIFICATE
4. ISSUING A CERTIFICATE
5. 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. College Of Pharmaceutical Education And Research
APMC

 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 scheme
http://www.who.int/medicines/areas/quality_
safety/regulation_legislation/certification
/guidelines/en/index.html


APMC College Of Pharmaceutical
Education And Research

WHO Certification Scheme Guidelines

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