DRUG REGUALTORY AUTHORITY

OF PAKISTAN

ISSUANCE OF GMP CERTIFICATES

 DETAILS

• Written by: Muhammad Adnan Faisal Saim- Deputy

Drugs Controller QA
• Reviewed by: Mr. Muhammad Arshad Khan- Director
QA/Legal Affairs
• Approved & Authorized by: Mr. Arshad Farooq
Fahim- Chief Executive Officer
 Document History

Version Effective Date Significant Changes Previous Version

00.01 01.06.2010 Initial version
00.02 01.04.2012 Consequential 00.01
amendments due
to establishment of
Drug Regulatory
Agency of Pakistan
00.03 01.06.2013 Establishment of 00.02
Drug Regulatory
Authority of
Pakistan Act no XXI
of 2012
PURPOSES
• Purpose of this SOP is to describe the
procedure for issuing the GMP
Certificate to licensed the
Pharmaceuticals Manufacturing Units.
• This SOP shall be followed for issuance
of GMP certificate to the applicants
intending to present it to relevant
authorities of Pakistan or abroad.
SCOPE
• This SOP applies to all the
Pharmaceuticals Units licensed under
the Drugs Act, 1976 and rules framed
there under.
• This SOP allows certification to
Pharmaceutical Units applying for the
grant of GMP certificate for export
purpose.
RESPONSIBILITIES
• Director (Quality Assurance and
Laboratory Testing) will be the authority
to permit the issuance of GMP certificate
for export purpose.
• Deputy Drugs Controller QA will be
responsible for processing the GMP
certificate (export purpose) after
observing all the codal formalities as per
procedure.
• A panel (approved by Director Quality Assurance and
Laboratory Testing) will be responsible for conducting
the inspection of the firm with reference to the GMP
compliance as per the GMP audit perform under
section B-II and submitting the report within 7 days.
• Assurance of maintaining the GMP as required
under the rules and quality through the authorized
periods rests with shoulder of applicant.
PROCEDURE
• The applicant for grant of GMP certificate
can made to office of the Director
(Quality Assurance and Laboratory
Testing), who will forward/mark to
Deputy Drugs Controller (QA) for
processing.
• Deputy Drugs Controller (QA) will
scrutinize the GMP inspection reports of
the concerned Pharmaceutical Unit as
per record available in the office.
• The GMP compliance of the Pharmaceuticals unit will
be evaluated on the basis of latest panel (approved
by Director Quality Assurance and Laboratory
Testing) report for inspection for GMP certification of
the unit as per GMP audit Performa under schedule
B-II. Such report of inspection shall not be older than
180 days of the receipt of application.
• If eGMP panel inspection of the firm is not
conducted within last 180 days of receipt of
application, a panel shall be constituted to conduct
the inspection of the firm to verify eGMP compliance
and submit the report as per eGMP audit performa
under schedule B-II within 7 days.
• The applicant shall provide the following documents for
obtaining the eGMP certificate for export purposes:
i. Request letter addressed to Director (Quality Assurance
and Laboratory Testing) along with the following
documents.
ii. Latest panel GMP inspector report as per eGMP audit
performa under schedule B-II conducted within last 180
days.
iii. Copy of valid Drug Manufacturing Liscence (DML).
iv. Fee amounting to Rs.5000/- as per SRO1117( 1)/2012
under the head/item of miscellaneous applications.
(S.No VIII)
v. Evidence of export for export purpose eGMP certificate.
a. A certificate from ADC to the effect of exports during
the last one year, or
b. A certificate/document in original from the importing
country to the effect of the
process/negotiations/registration for exports.
vi. vi. List of registered products (registration number
should be mentioned).
vii. Copy of NOC of Central Research Fund (CRF).
viii. If eGMP certificate expired, cancelled/withdraw or
incase of first application of eGMP certificate, two
previous inspection report within a year as per Drugs
Act, 1976 and rules framed there under will be
required.
ix. An undertaking on stamp paper (Rs.20/-) which will be
attested by Notary Public/Oath Commissioner, that there are
no case/litigation pending in any court/board or authority
which relates to quality control or quality assurance of
therapeutic goods and also there is no sample declared
spurious/substandard/adulterated at any laboratory e.g. CDL,
NIH, DTL, NCL etc. during a period of last 180 days.
x. The export purpose certificate will be issued for only one
country. Where the applicant intending to export more
country (ies) the applicant should deposit Rs. 5000/- for each
certificate.
• After evaluating the eGMP report of the frim the deputy
drugs controller (QA) will put up the case to Director
(Quality Assurance and Laboratory Testing) with
recommendation either for approval or disapproval as the
case may be.
• In case the application is approved by the Director (Quality
Assurance and Laboratory Testing), the Deputy Drugs
Controller will issue the eGMP certificate on approval
format (Annex-I) for export purpose.
• In case the application is not approved by the director
(Quality Assurance and Laboratory Testing), the
Deputy Drugs Controller will inform the applicant
accordingly along with reasons to this effect.
VALIDITY OF CERTIFICATE
• eGMP certificate issued as per this SOP
will remain valid for a period of one year
for export purpose from the date of
inspection unless withdrawn earlier.
• Incase of a requirement of an importing
country otherwise, a certificate from the
Health Authorities of the importing
country shall be produced.
WITHDRAWL OF CERTIFICATION
• eGMP certificate shall stand invalid if
either the activities or categories
certified therein are changed or not
conforming to the Drugs Act, 1976
and the rules framed there under.
REFERENCES
• The Drugs Act, 1976 (XXXI of 1976)
• WIIO Technical Report Series, No.
908.2003