Saturday, September 26, 2009


The pharmaceutical biotechnology
and medical device research and development
industries are among the most highly regulated
industries in the country. As India is growing very
rapidly in pharmaceutical sector, there is a need of
regulatory affairs professionals to cater the current
needs of industries for the global competition.
Regulatory affairs professionals are the link
between pharmaceutical industries and world wide
regulatory agencies. They are required to be well
versed in the laws, regulations, guidelines and
guidance of the regulatory agencies. There is a
growing need to incorporate the current
requirements of pharmaceutical industries in the
standard curriculum of pharmacy colleges to
prepare the students with the latest developments
to serve the industries. The present article
discusses the regulatory education and its need,
learning resources, courses available, syllabus
contents, and job opportunities in regulatory affairs.
I Introduction
As the pharmaceutical industries throuhout
the world are moving ahead towards becoming
more and more competitive, these are realizing that
the real battle of survival lies in executing the work
by understanding the guidelines related to various
activities carried out to give an assurance that the
process is under regulation. Pharmaceutical
Industry, being one of the highly regulated industries,
is in immense need of people than ever before who
are capable of handling issues related to regulatory
affairs in a comprehensive manner.
II Regulatory Affairs Education
The person indulging in the regulatory affairs
must be familiar with all the guidelines, guidances
and regulatory documents. He should have a

thorough understanding of a particular regulatory
document which has been drafted. Such people
are the primary communication link between the
company and worldwide regulatory agencies such
as USFDA1 (United States Food and Drug
Administration) and European Union of Drug
Regulatory Affairs (EUDRA).
A number of organizations such as the
Regulatory Affiars Professional Society (RAPS), the
Drug Information Association (DIA), the Food and
Drug Law Institute (FDLI) and international
organizations such as the European Society of
Regulatory Affairs play a vital role in providing
relevant information. Commercial training
companies such as Parexel-Barnett and the
Pharmaceutical Education and Research Institute
(PERI) conduct meetings on the regulatory affairs,
which would be helpful to the professionals.2
III. Institutions in India offering Regulatory
Affairs as one of the subjects in PG Course
A very few colleges and universities throughout
the world are offering `Pharmaceutical Regulatory
Affairs’ as one of the subjects.
In India, so far only two universities Guru
Jambeshwar University, Haryana and Manipal
College of Pharmaceutical Sciences, Manipal,
have initiated Such an effort. The curriculum deals
with the USFDA and EUDRA guidelines concerning
filing for New Drug Applications and Abbreviated
New Drug Applications; FDA, International
Conference on Harmonisation (ICH), EUDRA and
Pharmaceutical Inspection Convention (PIC)
guidelines for various operational activities;
Intellectual Property Rights such as Patents, Copy
Rights, Trademarks; etc for patenting.

In general, the curriculum comprises of
introductory foundation that outlines the health care
product research, development process and the
regulatory oversight of the complex processes.
There are both part-time and full-time courses
available for the subject. Part-time courses are
suitable for the professional who will come across
these terms occasionally where as full-time course
is meant for the professional who intends to make
his career in the regulatory affairs3 The course
material is also available in the from of online,
distance learning and interactive CDs mode.
Regulatory affairs position is in highest demand
and fastest growing according to the findings from
a recent survey on employment trends in the clinical
trials industry from CenterWatch4, the reasons
being the lack of candidates who wish to make their
career in this field and increasing turnover of the
pharmaceutical industries.
Pharmaceutical Regulatory affairs is a vast
area, which cannot be taught just with the help of
books or the course materials. The issues related
to the field are often updated so the professionals
find it challenging to keep abreast with the recent
modifications and inclusions.
Incorporating regulatory affairs into the
pharma curriculum will make the pharmaceutical

professionals working in the area of regulatory
affairs grow and keep learning. The professional
will be trained regarding what he is supposed to do
soon after he joins industry unlike the conventional
way of undergoing training under a qualified
regulatory practitioner right after joining the job. This
step will definitely ignite the power of knowledge in
the professionals and make them accustomed with
the working environment.
The recent trend is that the MNCs abroad are
looking forward to India as their preferred destination
for the drug development and research activities. It
gives more weightage to the need of expertise in
the field of regulatory affairs in the post-GATT
implementation age.

Monday, July 13, 2009


6. Training and education
As HACCP is a relatively new concept in the pharmaceutical industry, training of
personnel in industry, government and universities in HACCP principles and
applications is essential for its effective implementation.
In developing specific training to support a HACCP plan, working instructions
and procedures should be drawn up which define the tasks of the operating
personnel to be stationed at each critical control point. Specific training should be
provided in the tasks of employees monitoring each CCP.
Regulatory affairs in pharmaceutical
Cooperation between producers, traders and responsible authorities is of
vital importance. Opportunities should be provided for the joint training of
industrial staff and the control authorities to encourage and maintain a continuous
dialogue and create a climate of understanding in the practical application of


The following definitions apply to the terms as used in these gmp guidelines. They may
have different meanings in other contexts.
control (verb)
The taking of all necessary actions to ensure and maintain compliance with the
criteria established in the HACCP plan.
control (noun)
The state wherein correct procedures are being followed and criteria are being
control measure
Any action and activity that can be used to prevent or eliminate a pharmaceutical
quality hazard or reduce it to an acceptable level.
corrective action
Any action to be taken when the results of monitoring at the CCP (see below)
indicate a loss of control.
critical control point (CCP)
A step at which control can be applied and is essential to prevent or eliminate a
pharmaceutical quality hazard or reduce it to an acceptable level.
critical limit
A criterion which separates acceptability from unacceptability.
Failure to meet a critical limit.
flow diagram
A systematic representation of the sequence of steps or operations used in the
production, control and distribution of a particular pharmaceutical.

HACCP plan
A document prepared in accordance with the principles of HACCP to ensure the
control of hazards which are significant for pharmaceutical quality in the production
and supply chain.
Any circumstance in the production, control and distribution of a pharmaceutical
which can cause an adverse health effect.
hazard analysis
The process of collecting and evaluating information on hazards which should be
addressed in the HACCP plan.
The act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CCP is under control pharmaceuticals
All products related to pharmacy, including starting materials (active pharmaceutical
ingredients and excipients), finished dosage forms, and biological and other
specific products.
The collection and evaluation of data, beginning at the process development stage
and continuing through the production phase, which ensure that the manufacturing
processes — including equipment, buildings, personnel and materials — are
capable of achieving the intended results on a consistent and continuous basis.
Validation is the establishment of documented evidence that a system does what
it is supposed to do.
verification regulatory affairs in pharmaceutical
The application of methods, procedures, tests and other evaluations, in addition
to monitoring, to determine compliance with the HACCP plan.
4. Principles
The HACCP system is based on seven principles. In applying these principles, 12
stages are recommended and are discussed in section
7. Some stages are linked to
specific principles while others serve as an introduction to the concept.
The seven principles are:
1. Conduct a hazard analysis.
2. Determine the critical control points (CCPs).
3. Establish target levels and critical limit(s).