Monday, August 26, 2013

What is CAPA Corrective and preventive action

What is meant by CAPA (Corrective and preventive action) in Pharmaceutical manufacturing: 

In pharmaceutical manufacturing industry a facility involved in pharmaceutical manufacturing is required to meet laws laid down by FDA, one of important regulation for controlling quality of drugs being manufactured in good manufacturing practices guidelines listed in 21 CFR part 210, these guidelines mention that there should be a system laid down for reducing and eliminating noncompliance’s and deviations, by adapting systematic and scientific methodology. A part of quality assurance system is designed to find root cause of a noncompliance, or deviation, and a preventive action is designed and followed so that the noncompliance of similar nature does not occur again. To monitor the same a team of experts in Quality assurance and production, and regulatory, is formed and which analyze See here Guide For Pharma Regulatory affairs  Manufacturing Industry  

 1) Noncompliance's and their origin, root cause. Should clearly identify the origin, and root of noncompliance with data, and it should be able to establish in a reproducible manner if challenged.

2) Nature, its impact on product quality: The non-conformance or deviation should be analyzed for its impact on quality of product, the level at which its impact is there.

3) Design a corrective action: A scientifically formed system to eliminate the non-conformance, which is agreed by QA and Manufacturing team, and management.

 4) Design Preventive action: once non-conformance is observed , a systematic and scientifically designed preventive action is adapted at decided interval in the pharma manufacturing process, for example , a preventive maintenance of HVAC system which gives non-conformance with respect to quality of air being circulated in the manufacturing aria after a specified period, one can design a period period to such experienced and learned period for preventive maintenance

 5) Design a SOP for monitoring implementation of CAPA. To make sure that CAPA designed is able to take care of noncompliance which prevents its occurrence not occur again. For evaluation of effectiveness of CAPA is done by systematic evaluation of CAPA. (Corrective and preventive action) is one of regulatory requirement and it is subject to inspection by FDA as and when asked, hence its integral part of quality management system in a pharma facility. Non-conformance or non compliance's are required to be checked , in order to find them a routine system of internal audit or interdepartmental audits must be carried out.

Tuesday, January 11, 2011

A Beautiful Book By by Jim Plagakis “The Prisoners Of Comfort”

A beautiful book by Jim Plagakis .
Its a good book we recomend it to all our fellow pharmacists.
Visit for Five new Books by Jim Plagakis
He has written in a very great way about the institutionalization of pharmacists.
“Prisoners of comfort ” will be made available at too.

Thursday, October 14, 2010 Paramount among Pharmaceutical Manufacturing Guides Paramount among Pharmaceutical Manufacturing Guides

The pharmaceutical industry in the world is among the most astronomical systemized sectors. With a vast number of pharmaceutical companies, pharmacy colleges, and pharmacy students, the industry plays a vital part in endorsing and supporting development in the aspect of global medicine. The industry with its remarkable features has scaled new heights in the areas of research, development, manufacturing, and production. The technological proficiency and manpower involved in these pharmaceutical companies has resulted in its growth on a global level.

Every industry has vast in-depth knowledge about its working, manufacturing, and the regulatory affairs and conditions, on which it is based. Similarly to expertise in the pharmaceutical field, one should be well versed with all its related information regarding its manufacturing, research, development, and regulation. All this valuable and credential information can rendered to the people online through pharmaceutical blogs. Among those on internet, carves a niche in the market with a number of near about 2010 readers subscribed in a small duration. This zone of blogs covers almost each and every aspect of the pharmaceutical discipline. Except from the above mentioned areas, this website even focuses on providing the readers with the reviews on the latest developments, scientific analysis, and news in the pharma industry occurring globally. The website contains all the necessary information on Current Good Manufacturing Practices Pharmaceutical, pharmaceuticals manufacturing, GMP Guidelines, CGMP practices, and Quality assurance and regulatory affairs for pharmaceuticals adapted across the world.

The website can be considered as a vast sea of accurate knowledge in the field of drugs and pharmaceuticals. The articles submitted on the website are written by the highly rated authors, which include world-class pharmacists and pharma professionals. Being the best and latest, many of the articles are even included in the popular pharmaceuticals and medicine journals all over the world. Furthermore, the articles are even studied in institutions dealing in manufacture, development, and research in pharmaceuticals across the world. The current topics highlighted on the website are GMP documentation, CGMP requirements for pharmaceutical formulations, Quality Assurance guidelines, Good manufacturing practices, guidelines for SOP’s for microbiology department in pharmaceuticals, and Pharmaceutical Validations. proves to be guide not only pharmaceutical companies, but even for pharmacists and pharmacy students. The students can train themselves in pharmaceuticals CGMP practice and procedures by reading articles over the website. Being a multi-user and multi-beneficial website, it provides the grounds for the pharmaceutical professionals and students worldwide to share their views and thoughts. The blog relishes readership from the top and reputed pharma professionals belonging to elite pharmaceutical companies worldwide. With the day to day increase in the number of readers, now it is one of the most read and referred pharmaceutical information blog word wide.

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).