The document outlines the role of the FDA and CGMP (Current Good Manufacturing Practices) regulations in ensuring the safety and effectiveness of drugs and medical products. It details the requirements and procedures of CGMP compliance, including the consequences of non-compliance and the role of various international bodies, such as the Pharmaceutical Inspection Convention (PIC) and the World Health Organization (WHO), in promoting harmonization and quality standards. Additionally, it describes the responsibilities of the European Medicines Agency (EMEA) in the evaluation and supervision of medicinal products in the EU.

1. cGMP GUIDELINES
MS. Gauri R. Borude
Assistant Professor,
Pharmaceutical Chemistry Dept,
Sanjivani college of pharmaceutical
education & Research,kopargaon

2. • United States Food and Drug Administration
• What are CGMPs?
• Pharmaceutical Inspection Convention (PIC),
• WHO and EMEA
Session in Summary

3. United States Food and Drug Administration
• Food and Drug Administration – FDA is an agency within the U.S. Department of
Health and Human Services – FDA is responsible for protecting public health
• Ensuring foods are safe and properly labeled
• Ensuring that human and veterinary drugs, vaccines, and other biological
products and medical devices intended for human use are safe and effective
• Ensures that cosmetics and dietary supplements are safe and properly labeled
• Advancing public health by helping to speed up innovations that make medicines
effective, safe, and affordable
• Helping the public get accurate, science-based information on medicines and foods
to maintain and improve their health
• Regulating the manufacturing, marketing, and distribution of tobacco products
• Ensuring the security of the food supply, and development of medical products for
protection from public health threats

4. What are cGMPs?
• CGMP refers to the Current Good Manufacturing Practice regulations enforced
by the FDA.
• Provide for systems that assure proper design, monitoring, and control of
manufacturing processes and facilities.
• Adherence to the CGMP regulations assures the identity, strength, quality, and
purity of drug products by requiring that manufacturers of medications
adequately control manufacturing operations. Including: – Strong quality
management systems
– Obtaining appropriate quality raw materials
– Establishing robust operating procedures
– Detecting and investigating product quality deviations
– Maintaining reliable testing laboratories

5. • The CGMP requirements were established to be flexible in order to allow
each manufacturer to decide individually how to best implement the
necessary controls by using scientifically sound design, processing methods,
and testing procedures.
• It is important to note that CGMPs are minimum requirements. Many
pharmaceutical manufacturers are already implementing comprehensive,
modern quality systems and risk management approaches that exceed these
minimum standards.

6. • cGMPs are not just “best practice” they are law.
• Regulatory requirements of current Good Manufacturing Practices – After an FDA
audit inspection of a facility, the FDA may issue a “Form 483” of observations that
require a response
– If the manufacturer does not respond or remediate the Form 483 observation
the FDA may issue a warning letter
– If the manufacturer does not respond or remediate the observations in the FDA
warning letter, then the FDA may have a judge issue a court injunction that will impose
a consent decree that stops manufacturing
• If a company is not complying with CGMP regulations, any drug it makes is
considered “adulterated” under the law.
• While FDA cannot force a company to recall a drug, companies usually will recall
voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn
the public and can seize the drug.

7. Pharmaceutical Inspection Convention
• PIC is a combined term used for the execution of activities of pharmaceutical inspection
convention and pharmaceutical inspection cooperation scheme
• PIC was established to harmonize, educate and update aspects relating to good manufacturing
practices among member countries.
• It is a body that even harmonizes relations among regulatory authorities & governments.
ORIGIN OF PIC
• In 1995 PIC was established as a provision to streamline with long back established
Pharmaceutical Inspection Convention of 1970 with some flexibility in initially European
Commission was the body permitted to sign agreements with countries outside Europe.
• Since the European Commission is not a member of the Pharmaceutical Inspection
Convention of 1970 there was some incompatibility between European law and pic this
incompatibility did not allow EU countries that were members of PIC to have agreements
with countries that are seeking to join the pic format

8. Members of PIC
AUSTRIA
NORWAY
PIC
Denmark
Finland
Iceland
PORTUGAL

9. Functions of PIC
• To meet the objectives of PIC in terms of harmonization of GMP the committee
makes recommendations to update and improve GMP to promote cooperation
relating to Quality Assurance of inspections and quality systems of Inspectorate.
• Educate the authorities by means of training and exchange of Information and help
in bringing out new guidelines relating to manufacturing and quality control of
medicinal products.
• The committee also assists the system being practiced by a country for medicinal
products in terms of manufacture quality control along with protocols followed for
corresponding regulatory inspections or inspectors
• Decides suggestions and changes necessary for the country to become a
member of PIC.

10. ADVANTAGES WITH PIC
• PIC brings about an international harmonization among countries relating
to good manufacturing practices and quality maintenance systems of
medicinal products.
• In addition to this the implementation of high standards of quality along
with mutual understanding among members is achieved.
• PIC helps member regulatory authorities in sharing,facilitating,recalling
concluding aspects relating to manufacturing quality and inspection
systems among Inspector rates and pharmaceutical industries.

11. WHO
• World Health Organisation is established on 7th April 1948 it is specialised
nonpolitical health agency of the United Nation with headquarter in Geneva
• Switzerland it is responsible for providing leadership on Global Health
matters every year 7th of April is celebrated as World Health Day.s

12. Vision –The attainment or buy all people the
highest level of health
Mission- To lead strategic collaborative efforts among
member states and other partners to promote equity in
health to combat disease and to improve the quality length
and the lives of all the peoples of the world.

13. Organizational structure
World Health assembly
Executive board
Secretariat
Regions(6)
Member countries(193)

14. EMEA
• The EMEA began its activities when the European system for authorizing
medicinal products was introduced.
• European Medicines Agency EMEA is a decentralized body of the European
Union headquarters in London
• It's main responsibility is the protection and promotion of public and
animal health through the evaluation and supervision of medicines for
human and veterinary use

15. • The EMEA is primarily involved in the centralized procedure.
• where the centralised procedure is used companies submit one single
marketing authorization application to the EMEA
• a single evaluation is carried out through the committee for medicinal
products for human use or the committee for medicinal products
for veterinary use
• The committee on herbal medicinal products was established in 2004 and
provides scientific opinions on traditional herbal medicines
• the main responsibility of the pediatric committee is to assess the content
of pediatric Investigation plans and adopt opinions on them
following regulation