Mrs.Shilpa P. Chaudhari

Certification is an affirmation or proof that the products or services are
approved and evaluated by a governing body that has the ability to create reserved
rights . Certification provides reliable evidence to the company’s image and
marketability of its product and services .It puts small and medium sized companies
on par with large companies. The present article reviews WHO,
ISO, FDA,
TGA ,
ICH, ASTM , EPA
in terms of its organization, headquarters and objectives.

Introduction

Definition of “certification”

Certification is a affirmation or proof that the products or services are
approved and evaluated by a governing body that has the ability to create reserved
rights.

List of certifying agencies:

1. ISO (International Standard
   Organization)
   
2. WHO (World Health Organization)
   
3. FDA (Food and Drug Administration)
   
4. ICH (International conference
   on Harmonization)
   
5. MCA (Medicine Control
   Agency) (now as MHRA)
   
6. ASTM (American Society
   of Testing and Materials)
   
7. EPA (Environmental Protection
   Agency)
   
8. TGA (Therapeutic Goods
   Administration)

Among these WHO, USFDA, ICH, MCA, TGA, are the regulatory authorities whereas
ISO, ASTM, EPA, are the standard institutions.

1. WHO (World Health Organization)

WHO, the United Nations specialized
agency for health, was established on 7^th April 1948. “Health” is defined
in WHO’s constitution as a state of physical , mental and social well being and
not merely absence of disease or affirmity¹. WHO is governed by 192
member state throughout the world health assembly.

Organization(in the order of hierarchy): (Fig I)

Headquarter
is situated in AVENUE APPIA, 20, 1211, Geneva,
27, Switzerland.

Objectives²

• Organizes and funds health care programs
  
• Improves nutrition , working conditions and sanitation
  
• Promotes and conducts research in the field of health.
  
• Setting global norms and standards.
  
• Essential drugs and medicines Policy³
  
• First model list of essential drugs was published in 1977 and updated with every 2 years⁴.
  
• New GMP’s are being developed for active, pharmaceutical ingredients in order to extend the existing guidelines^5.
  
• WHO developed the guidelines on Good Agricultural And Collection Practices (GACP) for medicinal plants providing technical assistance on obtaining medicinal plant material of good quality for the sustainable production of herbal products classified as medicines⁶.
  
• A WHO model formulary for essential drugs is being developed⁷

Principle

• Common health problem of majority of population can be treated with a small carefully selected number of medicines.
  
• Procurement, distribution , and other supply activities can be carried out most economically and efficiently with limited number of drug products.
  
• Relationship was established between treatment guidelines and list of essential medicines.

WHO certification scheme⁸

The request for GMP’s by member countries was followed by request for certification
scheme in 1968. The scheme provided for regular publication of a list of certified
manufacturers. The scheme also provided for batch certificates from drug regulatory
authorities of exporting country. Subsequently it was felt that the scheme was
impracticable and hence it underwent the first revision in 1975. The revised
scheme dropped the provision for publication of certified manufacturers and
replaced it with provision for product certificates. The second revision of
scheme was discussed by WHO export committee in Dec 1992. The certification
scheme has now been extended to include certification of:

• 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.

The scheme is a administrative mechanism which requires each participating member state to attest the following to the competent authority of another participating member state on application by a commercial interested party. A specific product is authorized to be placed on the market within its jurisdiction or , if it is not thus authorized , the reason why the authorization has not been accorded .The plant in which it is produced is subject to inspection at suitable intervals to establish that the manufacturer complies to GMP as recommended by WHO. All submitted information , including labeling currently authorized in the certifying country. Any member states which intended 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 and name and address of its national drug regulatory authority and other competent authority. Three types of certificates can be requested under the scheme:

·A certificate of pharmaceutical product.

·A statement of licensing status of pharmaceutical product .

·A batch certificate of pharmaceutical product.

2. US FDA ( United State Food and Drug Administration):

It is a scientific, regulatory, public health agency. The agency grew from a single chemist in the US department of Agriculture in 1862 to a staff of approximately 9100 employees, staffing over 150 field officers , 5 regional offices and 20 district offices. Harvey Wiley arrived as a Chief chemist in 1883 and he unified a variety of groups in the federal law to prohibit the adulteration and misbranding of food and drugs. Head Quarter is situated in White Oak, Montgomery County, Maryland.

Organization: Fig II

Objectives:

USFDA is
a federal agency responsible for ensuring that food products are safe, wholesome
and sanitary , human and veterinary drugs, biological products and medical devices
are safe and effective. FDA also ensures that these products are honestly, accurately,
and informatively represented to the public. Following are the products regulated
by the FDA.

1.Biologics : FDA regulates the product and manufacturing establishment licensing , safety of nations blood supply. It also conducts research to establish product standard and develop improved testing methods of biologics.

2.Cosmetics: FDA regulates safety and labeling of cosmetics.

3.Drugs: FDA is responsible for product approval, OTC and prescription drug labeling ,drug manufacturing standards.

4.Food: FDA is concerned with the labeling and safety of all food products and bottled water.

5.Medical devices: FDA is concerned with the premarket approval
of new devices manufacturing and performance standards.
It also keeps a track of reports regarding device
malfunctioning and serious adverse reactions.

6.Radiation emitting electronic products:FDA governs radiation safety performance standard for microwave ovens, telephone receivers, diagnostics. It accredites and inspects mammographic facilities.

7.Veternary products: FDA regulates livestock feeds pet foods veterinary drugs and services.

Organizations:

The department of health and human services
is headed by the office of Commissioner
Dr. Lester Crawford.

The foundation of FDA Department of Health and Human services is formed by the following centers:

1.Center for Food Safety and Applied nutrition.

2.Center for Drug Evaluation and Research

3.Center for Veterinary Medicine

4.Center for Devices and Radiological Health

5. National Center for Toxicological Research.

1.Center for food Safety and Applied Nutrition

·Developed rapid methods for viral and microbial
detection.

·Controls food borne diseases.

·Plays leading role in protecting nation
against bioterrorism

·Following attacks on Sept 11 2001, FDA
has additional resources of food inspectors, lab
specialist to prevent distribution of suspected food
imports.

2.Center for drug evaluation and research

They have developed

· Wristwatch like device for diabetics that
automatically checks the wearer’s glucose level
every 20 minutes and sounds an alarm if
it is dangerously high.

· A swallowable capsule with tiny camera that
snaps pictures as it moves through small
intestine, these devices helps detect bleeding
and other abnormalities reachable by endoscope

·An inflatable device that is surgically
placed around upper stomach of greatly overweight
patients who can loose weight by dieting
and are at serious risk for weight associated
serious diseases such as hypertension,; the device limits
their food consumption and creates feeling of
fullness.

· CDER 2003 approved 78 new drugs out of
which 17 were new before marketed in US.

3.Center for veterinary medicine:

Prevent the establishment of bovine spongiform encephalopathy “ mad cow disease”.

Animal feed rule

·Eliminates the present exemption in feed
rule that allows mammalian blood and blood
products to be fed to other ruminants such
as protein source.

·Scanning use of poultry litter as a feed
ingredient for ruminant animal.

4.Center for devices and radiological health:

·Develops contact lenses to implanted hip
joints and heart values.

·The center also monitors devices throughout
product life cycle, including nation wide post
market surveillance system.

·Assures radiant emitting products meet radiation
safety standards.

·The center invented a robotic arm that
can operate a variety of surgical tools
with tremendous precision and it is first
of its kind.

5.National health for toxicological research.

· This involves fundamental and applied research
specially designed to define biological mechanisms
of action underlying the toxicity of products
regulated by FDA.

{mospagebreak title=ICH}

3.ICH: (International Conference on Harmonization)

The realization that it is important to have an independent evaluation of medicinal
product before they are allowed in the market was reached at different regions.
In US a tragic mistake in the formulation of a children syrup in the 1930s was
the trigger for setting up the product administration system under FDA
.In Japan, government regulations requiring all medicinal products to be registered
for sale started in 1950.In Europe, the trigger was the thalidomide tragedy
of the 1960’s which also regulated that the new generation of synthetic drugs
revolutionizing medicine had the potential to harm as well as heal. The birth
of ICH took place in a meeting in April 1990⁹,
in Brussels. Head Quarter is situated in Geneva, Switzerland.

Organization (fig III):

Objective: Harmonization of pharmacopoeial standards
probably began at International Congresses of
pharmacy between 1865 and 1910¹⁰, but
the first formal attempt can be traced
to 1902. The purpose is to make
recommendations on ways to achieve greater
harmonization, interpretation, and application of
technical guidelines and requirements for
product registration in order to reduce
or obviate the need to duplicate the
testing carried out during the research
and development of new medicines. The objective
of such harmonization is a more economical
use of human, animal, and material resources,
and the elimination of unnecessary delay
in the global development and availability
of new medicines whilst maintaining safeguards
on quality, safety, and efficacy and
regulatory obligations to protect public
health. This mission is embodied as the
TERMS OF REFERENCE OF ICH. The ICH
process for harmonization guidelines:

I. Overview

II. Initiation of ICH harmonization
action:

a)Proposal for harmonization action:

1. New types of medicinal products

2. Lack of harmonization in current technical requirements.

3. Transition to technically improved testing procedures.

4. Review of existing ICH
guidelines.

5. Maintenance of an existing guidelines.

6. Preparation of a concept paper

7. Selection of a procedure

III. Full ICH process for
major Harmonization topics

1. Topic selection and participation of interested parties.

2. Steering committee action

3. Expert Working Groups

4. Time taken and action plans

5. Steps in ICP process.

a)Consensus Building

b)Sign off by the expert working groups¹¹

c)Start of regulatory action.

d)Regulatory consultation

e)Adoption of a tripartite Harmonized text

f)Implementation

IV. Abbreviated process for maintenance of guidelines

V. Types of maintenance

ICH registers the drug on
the basis of three criteria¹²

a.Quality

b. Safety

c. Efficacy

4. UK MCA (Medicines Control Agency)

MCA now operating as
“MHRA - Medicines and Health Care products and agency"
is the regulatory body responsible for the approval and licensing of all medicinal
products sold within the U. K. It evaluates approx 1000 product applications,
20000 variations of existing licenses annually and deals with 75000 adverse
drug notifications every year.

H. Pattichis was the founder of MCA. Head quarter
is situated in The Medicines Control Agency 16^th
floor. Market Towers,1 Nine Elms, Vauxhall , London.

Objectives:-

1. MCA may be called on to determine if
   a product is a “medicinal product”.
   
2. the act provides that unless exempt any
   other “medicinal product” must not be sold
   or supplied without a marketing authority.
   
3. The MCA decides the borderline between the
   medicines food products, cosmetics or medical
   devices.
   
4. Cosmetics: MCA places restrictions on certain
   ingredients and defines a cosmetic product. The
   definition encourages that the cosmetic product
   may have a secondary preventive but not
   a curative purpose.
   
5. Food products including dietary supplements:
   
6. Herbal medicines : Does not apply to
   a herbal remedy on open rate if any
   name other than those of the herbal constituent
   is given to the remedy or if it
   is sold or supplied with written recommendations
   for use.


7. Medical devices: Their intended action is typically
   fulfilled by physical means and mechanical, physical
   barrier, replacement of it.

Organization: Fig IV

5. TGA (Therapeutic Goods Administration)

The TGA act which came into effect on
15 Feb 1991, is to provide a national framework for regulation of therapeutic
good in Australia and ensure their quality, safety and efficacy. Any product
for which therapeutic claims are made must be entered in the Australian Register
of Therapeutic Goods before the product can be supplied in Australia. Head Quarter
is situated in Australia.

A “Therapeutic Good” is broadly defined as a good which is represented in anyway to be, or is likely to be taken to be for therapeutic use, unless specifically excluded or included under section 7 of the therapeutic Goods Act 1989.

Organization: Fig V

Objectives:

Regulation of therapeutic goods is carried
out by overall control of supply of therapeutic
goods through three main processes:

1. Pre market assessment

2. Licensing of manufacturers

3. Post market vigilance

Standard Institutions-

I. ISO (International Organization for Standardization)

ISO is a network of national standards institutes
of 146 countries on the basis of one member per country. Head Quarter is situated
in Geneva, Switzerland.

Organization: Fig VI

REMCO- Committee on reference materials

Objective of ISO:-

ISO develops international standards which are useful to industrial and business
organizations of all types, conformity assessment professionals, to suppliers
and customers of products and services in both public and private sectors. They
make trade between countries easier and fairer. They aid in transferring technology
to developing countries when thing go well and systems machinery and devices
work well then often it is because they conform to standards set by ISO.

Process of developing ISO standards includes:

a)Consensus

b)Industry wide

c)Voluntary

ISO 9000 and ISO 14000:

The standards that have earned the 1S0 9000 and ISO 14000 families a worldwide reputation are known as “Generic management system standards”

Generic means that the same standard scan be applied to any organization large or small, whatever, its product including whether its product is actually a service – in any sector of activity. Management system refers to what the organization does to manage its process or activities.

ISO 9000 is concerned with quality management and ISO 14000 is primarily concerned with environmental management.

Some of the ISO norms listed below¹³:

1.ISO 9000: Quality management and
quality assurance standards guidelines for selection
and use.

2.ISO 9001: Quality systems: Models for quality assurance in designs ,development,
production, installation and servicing.

3.ISO 9002: Quality systems: Model for quality assurance in production and installation.

4.ISO 9003: Model for quality assurance in final inspection and trust.

5.ISO 9004: Quality management and quality systems elements guidelines.

6.ISO 14000: 2002- Environmental management that is integrating environmental aspects into product design and development.

Elements of ISO 9000:

· Quality policy

· Quality management

· Quality systems

· Records

· Control of documentation and subsequent changes

· Final inspection and testing of product service

· Inspection status of product during manufacture

· Reservation

· Training

In short,

Say what you do,

Do what you say, Prove it.

Describe your quality system,

Make your system work,

Have your system certified by an independent third party.

II.ASTM :(American society for testing
and materials)

ASTM was formed over a century ago when
forward thinking group of engineers got together to address frequent rail breaks
in railroad industry. This led standardization of steel ASTM was established
in 1898 .Head Quarter is situated in 100, Barr Harbor Drive , West Conshohocken,
Pennsylvania, USA.

Organization: fig VII

Objectives: Individuals, companies, agencies
around the world use ASTM standards. Travellers
on land and air are assured of the
standard quality of the fuels they use wherever
they go because of the ASTM standards
for petroleum recognized around the world. ASTM
is a not-for-profit organization that provides
a forum for the development and publication
of voluntary consensus standards for materials,
products, systems, and services.

F-24 standards: The US amusement ride industry builds and operates rides in accordance with a set of voluntarily engineering standards developed by ASTM called ASTM F –24 standards.

ASTM forms the heart of product safety in this industry defining standard practices
in ride design , manufacturing operation , maintenance, inspection, accident
or incident logging.

{mospagebreak title=BIS}

III.BIS: (Bureau of Indian Standards)

· It is the national standards body of
India, resolves to be the leader in all matters
concerning standardization , certification and quality.

· It was previously established as Indian Standards Institution in 1947.

Headquarter is situated in: Manak
Bhavan, Bahadur Shah Zafar Marg,India.

Organization: fig VIII.

Objectives:

BIS is engaged in formulation of Indian
standards for following sectors:

1. Basic and production engineering

2. Chemicals

3. Electronics and telecommunication

4. Electro technical

5. Food and agriculture

6. Petroleum Coals and Related products

7. Textile

8. Water resources

{mospagebreak title=EPA}

IV.EPA (Environmental Protection Agency)

An act to provide for the protection
and improvement of environment and for matters
connected therewith. This act came into force
on 23^rd May 1986¹⁴. It aims
to provide safety to growing public
demand for cleaner air, water and land. Head Quarter
is situated in Washington.

Objectives:

· Performs environmental research

· Offers financial assistance, research grants, and graduate fellowships.

· Perform environmental research.

Branches of EPA

1. Office of enforcement and compliance assurance

2. Office of solid waste

3. Toxic substances control act

4. Federal Insecticide, fungicide and Rodenticide act.

Other agencies

1. BSS (British Standards Society)

2. AACC ( American association for clinical chemistry)

3. SQA (The Society of Quality Assurance)

4. AACC ( American Association of cereal chemistry)

5. NIST (National Institute of Standards and Technology)

For more information following are the sites available:

Sr No.	Name of agencies	Websites
1.	WHO	www.who.int
2.	USFDA	www.fda.gov
3.	ICH	www.ich.org
4.	UKMCA	www.mca.gov.uk
5.	TGA	www.tga.gov.au
6.	ISO	www.iso.org
7.	ASTM	www.astm.com
8.	BIS	www.bis.org.in
9.	EPA	www.epa.org

 

{mospagebreak title=Conclusion and References}

Conclusion:-

Standards make an enormous contribution to
most aspects of our lives although
very often their contribution is invisible.

Standards by regulatory agencies play a
main role in raising levels of quality,
safety, reliability, efficiency and interchangeability,
as well as is providing benefits at as commercial
cost.

References:

1. S.C. Mandal, Concept of Essential Drugs
and Rational Use of Drugs, Pharma Times,
34(11), 9(2002).

2. M.M. Everard, “WHO And The Essential Medicines Concept” in Pharmaceutical
Practice,A.J.Winfield , R.M.E Richards, 3^rd ed(2004), 50-55.

3. Report of WHO Expert Committee On Use Of
Essential Drugs, WHO Technical Report Series 867, Geneva, 1997.

4. J.E Idanpaan-Heikkila, “WHO And The Harmonisation Of Regulatory Requirements
For Medicinal Products”in Encyclopaedia of Pharmaceutical Technology,
J Swarbrick, J Boylan,Marcel Dekker Inc;18(354-357).

5. Report Of WHO Expert Committee On Use Of Essential Drugs, WHO Technical Report Series 863, Geneva, 1996.

6. WHO Guidelines On Good Agricultural and Collection Practices (GACP) For Medicinal Plants, WHO regional office for South East Asia, Pharma Times, 36(7), 12(2004).

7. WHO Model Formulary, WHO Drug
Information, 11:23(1997).

8. P.P Sharma, How to practice GMP, Vandana
publication,2^nd ed, 88-102.

9. P Shenoy , International Committee on Harmonization-Current
Focus,PharmaTimes, 36(12), 36(2004)

10. D’Arcy, P.F and Harron,D.W.G, eds; Proceedings Of
First International Conference On Harmonization,Queens
University Of Belfast,1992.

11. J.A. Halperin, L.T. Grady, “Pharmacopoeial Standards:USP in Encyclopaedia
of Pharmaceutical Technology, J Swarbrick, J Boylan,Marcel Dekker Inc;
12(93-96).

12. S. Singh , Understanding The Veterinary ICH (VICH)
Harmonization Process ,Pharma Times, 32(11), 12-13(2000).

13. S.R. Choda , ISO:9000 Quality Management Systems in Pharmaceutical sector, Pharma Times, 35(1), 7-11(2003).

14. The Environmental Protection Act 1986, Universal Law Publishing Co. Pvt.
Ltd, 3^rd ed 003),1.

AboutAuthors

Shilpa P. Chaudhari^*, Pravin D. Chaudhari¹,
Hitha S. Salian², Avinash D.Deshpande³

Pad. Dr D.Y Patil Institute Of Pharmaceutical Sciences And Research,Pimpri,
Pune-18.

Shilpa P. Chaudhari¹

Lecturer,Pad.Dr.D.Y.Patil College of pharmacy, Pimpri, Pune- 18Maharashtra,
India.

Ph. - +91-20-27420261 + 91-20-27271436

Fax - +91-20-27420026Mobile- 09850179873

E.mail- pdchaudhari_21 @yahoo.co.in pdchaudhari@rediffmail.com

Pravin D.Chaudhari*

Assistant Professor,

Department of Pharmaceutics, Pad.Dr.D.Y.Patil Institute of Pharmaceutical Sciences
and Research,Pimpri, Pune- 18

Maharashtra,India. E.mail- pdchaudhari_21 @yahoo.co.in, pdchaudhari@rediffmail.com

Mobile- 09850179873 Fax - +91-20-27420026

Hitha S.Salian,

M.Pharm (Quality Assurance Techniques),

Pad.Dr.D.Y.Patil Institute of Pharmaceutical Sciences and Research,Pimpri,
Pune- 18 Maharashtra, India.

E.mail : hitha31@rediffmail.com, hitha31@yahoo.com

Mobile no.-9890308189

Prin. (Dr.) Avinash D.Deshpande,

M.Pharm. (Pharmac), Ph.D.(Med.),

Pad.Dr.D.Y.Patil Institute of Pharmaceutical Sciences and Research,Pimpri,
Pune- 18Maharashtra, India,

Ph. - +91-20-27420261 +91-20-27420026

Fax-+91-20-27420261 E.mail.: dypcop@pn2.vsnl.net.in