E-DRUG: GMP inspection study
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[To respond DO NOT CLICK REPLY. If you would like more clarification or information please contact Rania <rhas029@auckland.ac.nz>]
Dear colleagues,
I would like to invite you to take part in the study entitled Evaluation of
current inspection practices to develop a best model for inspection of the
pharmaceutical facilities.
[This study is approved by the University of Auckland Ethics Research Committee.
Reference number: 2009 / 003].
Introduction
A major facet of the pharmaceutical industry is the process of inspection of facilities
to ensure that they comply with the requirements and relevant standards of
Good Manufacturing Practice (GMP), and that all necessary systems are
in place. In a time, when globalization of industry is continuing apace, many
countries are entering export markets and hence become involved in the inspection
requirements of other countries.
In the developed world, compliance to international standards of GMP is relatively well established and
manufacturers are obliged to follow these standards. However, many countries in the
developing world, including the Middle East and the Gulf, are going
through rapid changes to catch up with getting their factories certified to GMP
in order to develop their export market to apply for international tenders.
One way of doing this is to carry out inspections by a national regulatory authority.
Currently, in the gulf countries infrastructure is only now being
developed and there is no competent inspectorate in place. Moreover,
the policies and guidelines followed by the regulatory bodies are not well
documented. This is the opposite of the structure in USA, Japan and EU
countries. Thus, the general aim of my study is to evaluate the current
inspection practices in different countries of the world and to develop
a model of best practice for and inspection of, pharmaceutical facilities for
the Gulf region. This might form the basis for an internationally agreed GMP for
the pharmaceutical industry.
Participating countries: New Zealand, Australia, Egypt Gulf Cooperation Council (GCC).
Target groups:
Inspectors from different regulatory authorities. Pharmaceutical facilities. (Quality Assurance staff).
Methodology:
Part a
A survey has been developed, in the form of a questionnaire. The target
responders to this survey will mainly be inspectors currently in relationships
with pharmaceutical companies. This will provide us with the knowledge of level
of awareness of policies, roles and procedures among the inspectors and the
pharmaceutical facilities.
This will help me to arrive at a point where I can standardize a plan to be followed while
inspecting in Gulf Countries.
Part b
The literature part will include a review from the previous works in the inspection
practices and guidelines in different regulatory bodies. The review will
consist of E-journal, edited books, research articles and online websites
related to the topic of my research. The systematic review will explain the
background of the different regulations and policies of inspection practices in
various regulatory bodies and the role of inspectors and the pharmaceutical
facilities.
So if you are involved in pharmaceutical industry or
regulatory body in one way or another, or would like to take part in the study
kindly respond me in the email given below.
Thank you in advance for your time. I appreciate your help and participation with this
research project.
Yours Sincerely,
Ranya Hasan (The researcher)
School of Pharmacy
The University of Auckland, New Zealand
rhas029@auckland.ac.nz
Supervisors contact details
Academic Supervisor
Associate Professor Sanjay Garg
Faculty of Medicine and Health Sciences
School of Pharmacy
Building NO.
504, Room 0040
Phone 64 9
3737599 ext. 82836
Email: s.garg@auckland.ac.nz
Academic Co-Supervisor
Senior lecturer Raida Al-Kassas.
Faculty of Medical and Health Sciences
School of Pharmacy.
Building NO. 504, 85 Park Road, Grafton
Phone 64 9
3737599 ext. 82836
Email: r.al-kassas@auckland.ac.nz
Dr Zaheer-Ud-Din
Babar B.Pharm.,MPharm(Clin Pharm).,PhD
Lecturer in Pharmacy Practice
School of Pharmacy
Faculty of Medical & Health Sciences
The University of Auckland
Private Mail Bag 92019, Auckland New Zealand
Ph: +64 9 3737599 Ext 88436
Fax: +64 9
3677192
Email: z.babar@auckland.ac.nz