Pharma

1. Drug
Regulatory
Course code: Pharm 4703
Course title: Pharmaceutical Quality Assurance

2. Drug Regulatory Authorities
• A regulatory agency is a public authority or government agency.
• An independent regulatory agency is a regulatory agency that is
independent from other branches or arms of the government.
• Regulatory agencies deal in the area of administrative law—
regulation or rule making.
• Regulatory agencies are usually a part of the executive branch of
the government.
• Their actions are generally open to legal review. Regulatory
authorities are commonly set up to enforce Standards and safety.

3. International Drug Regulatory Authorities
 USA- Food & Drug Administration (FDA)
 Europe- The European Agency for the Evaluation of Medicinal
Products (EMEA) .
 Japan-Ministry of Health, Labour & Welfare(MHLW).
 Australia-Therapeutic Goods Administration (TGA).
 Brazil-National Health Surveillance Agency (ANVISA).
 Nigeria-National Agency for Food and Drug Administration and
Control (NAFDAC).
 China-State Food and Drug Administration (SFDA).
 India-Central Drugs Standard Control Organization (CDSCO).
 Uganda-Uganda National Council for Science and Technology
(UNCST).
 International –International Conference on Harmonization (ICH) ,
World Health Organization (WHO).
 Gulf countries- The Gulf Central Committee for Drug Registration
(GCC-DR).

4. Global Regulatory Guidelines
 ISO Guidelines (International Organization for Standardization)
 WHO Guidelines (World Health Organization)
 US-FDA Guidelines (United State Food & Drug Administration)
 ICH Guidelines (International conference on Harmonization)
 PIC/S Guidelines (Pharm. Inspection Convention & Pharm.
Inspection Co-operation Scheme)
 IPEQ Guidelines (International Pharmaceutical Excipients Council)

5. Drug Regulatory Agencies

6. Directorate General of Drug Administration (DGDA)
Directorate General of Drug Administration (DGDA) under the Ministry of
Health & Family Welfare, Government of the People's Republic of
Bangladesh, is the Drug Regulatory Authority of the country.
DGDA supervises and implements all prevailing Drug Regulations in the
country and regulates all activities related to import, procurement of raw
and packing materials, production and import of finished drugs, export,
sales, pricing, etc. of all kinds of medicines including those of Ayurvedic,
Unani, Herbal and Homoeopathic systems drugs and medicines.
Historical Background
Before 1971- An organization under the Central Govt. of Pakistan under the
Controller of drugs.
After the war of liberation- An attached department of the Ministry of
Health and Population Control.
Since 1976- A separate Directorate directly under the Ministry of Health and
Family Welfare, 17 January 2010 upgraded as the Directorate General of
Drug Administration.

7. Vision and Mission of DGDA
Vision:
 DGDA shall strive to ensure quality and safe medicines for all.
Mission:
 To safeguard the health of humans and animals by ensuring the
medicines and medical devices meet applicable standards of safety,
quality and efficacy.
 To ensure the safety and security of supply chain for medicines and
medical devices.
 To ensure availability including accessibility and affordability and rational
use of essential medicines.
 To foster a regulatory environment that supports research and
innovation and thereby ensures moving towards global standards for
quality products.

8. Basic Responsibilities of DGDA
 The responsibilities of this organization are as follows:
 To ensure the quality, safety, efficacy and usefulness of all kinds of drugs
and medicines including Homeopathic, Unani, Ayurvedic and Herbal drugs
which are produced , imported and marketed in the country and also
exported to overseas.
 To make essential drugs available and affordable to the common people
of the country.
Major Functions of DGDA
 Evaluation of the proposals of new projects of all systems of medicines.
 Issue and renewal of drug manufacturing licenses.
 Issue and renewal of retail and whole sale drug licenses.
 Registration and renewal of drug products.
 Fixation of price and certification of price for drug products.
 Inspection of pharmaceutical establishments.
 Approval of block list for the import of raw- and packaging materials.

9. Committees of DGDA
 Standing Committee for Import of Pharmaceuticals
 Adverse Drug Reaction Advisory Committee (ADRAC)
 Drug Control Committee (DCC)
 Technical Sub-Committee (Human Medicine) for DCC
 Medical Device Technical Sub-Committee for DCC
 Herbal Medicine Advisor Committee (TSC) For DCC
 Price Fixation Committee
 Price Fixation Technical Sub-committee
 National Unani and Ayurvedic Formulary Committee
 Approval of indent for import of finished drugs.
 Surveillance and pharmacovigillance activity.
 Prosecution of cases in the drug courts and other courts.
 Issue of export licenses, FSC (Free Sales Certificate), GMP (Good
Manufacturing Practices) Certificate & CPP (Certificate for
Pharmaceutical Products.).

10. Medicines and Healthcare Products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is an
executive agency of the Department of Health and Social Care in the United
Kingdom which is responsible for ensuring that medicines and medical devices
work and are acceptably safe.
MHRA was formed in 2003 with the merger of the Medicines Control Agency
(MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with
the National Institute for Biological Standards and Control (NIBSC) and was
rebranded, with MHRA identity being used solely for the regulatory center
within the group.
Structure
MHRA is divided into three main centers:
MHRA Regulatory- UK’s regulator of medicines, medical devices and blood
components for transfusion, responsible for ensuring their safety, quality and
effectiveness.
Clinical Practice Research Datalink (CPRD)- an observational and
interventional research service that operates as part of the UK Department of
Health.

11. Advisory Bodies of MHRA
 MHRA has a number of independent advisory committees to provide impartial advice to
ministers about the regulation of medicines and medical devices. These committees may
also establish working groups to address specific problems.
 Advisory Board on the Registration of Homeopathic Products
 Herbal Medicines Advisory Committee
 The Review Panel
 Independent Scientific Advisory Committee for MHRA database research
 Medicines Industry Liaison Group
 Innovation Office
 Blood Consultative Committee
 Devices Expert Advisory Committee
National Institute for Biological Standards and Control (NIBSC)- a global leader in the field
of biological standardization. It is responsible for developing and producing over 90% of the
biological international standards in use around the world.

12. Roles/Responsibilities of MHRA
 Operate post-marketing surveillance for reporting, investigating and monitoring of
adverse drug reactions to medicines and incidents with medical devices.
 Assessment and authorization of medicinal products for sale and supply in UK.
 Oversee the Notified Bodies that ensure medical device manufacturers comply with
regulatory requirements before putting devices on the market.
 Operate a quality surveillance system to sample and test medicines to address quality
defects and to monitor the safety and quality of unlicensed products.
 Investigate internet sales and potential counterfeiting of medicines, and prosecute where
necessary.
 Regulate clinical trials of medicines and medical devices.
 Monitor and ensure compliance with statutory obligations relating to medicines and
medical devices.
 Promote safe use of medicines and devices.
 Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.

13. Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) is the regulatory body for
therapeutic goods (including medicines, medical devices, gene technology,
and blood products) in Australia. The TGA is responsible for conducting
assessment and monitoring activities to ensure that therapeutic goods
available in Australia are of an acceptable standard and that access to
therapeutic advances is in a timely manner.
TGA Expert Advisory Committees
The TGA has nine different statutory expert committees it may call upon to
obtain independent advice on scientific and technical matters, including:
 Advisory Committee on Biologicals (ACB)
 Advisory Committee on Complementary Medicines (ACCM)

14. Role of the TGA
The TGA carries out an overall control through five main processes:
 Pre-market evaluation and approval of registered products intended for
supply in Australia;
 Development, maintenance and monitoring of the systems for listing of
medicines;
 Licensing of manufacturers in accordance with international standards of
GMPs
 Post-market monitoring, through sampling, adverse event reporting,
surveillance activities, and response to public inquiries;
 The assessment of medicines for export.
 Advisory Committee on Medical Devices (ACMD)
 Advisory Committee on Non-prescription Medicines (ACNM)
 Advisory Committee on Prescription Medicines (ACPM)
 Advisory Committee on the Safety of Medical Devices (ACSsMD)
 Advisory Committee on the Safety of Medicines (ACSOM)
 Advisory Committee on the Safety of Vaccines (ACSOV)
 Therapeutic Goods Committee (TGC)

15. What is ISO?
The ISO Standard was developed in Geneva, Switzerland by the International
Organization for Standardization (ISO) and is an internationally recognized
quality benchmark that can be applied to any business in any environment.
It was founded in 1946 to promote the development of international
standard and related activities, including conformity assessment, to facilitate
the exchange of goods, services, and to develop cooperation in intellectual,
scientific, technological, and economic activity worldwide.
ISO-9000 and its concepts of Quality Management
The ISO 9000 family addresses various aspects of quality management and contains some of
ISO’s best known standards. The standards provide guidance and tools for companies and
organizations who want to ensure that their products and services consistently meet
customer’s requirements, and that quality is consistently improved.
ISO 9000 is a set of international standards on quality management and quality assurance
developed to help companies effectively document the quality system elements to be
implemented to maintain an efficient quality system. They are not specific to any one industry
and can be applied to organizations of any size. ISO 9000 can help a company satisfy its
customers, meet regulatory requirements, and achieve continual improvement. However, it
should be considered to be a first step, the base level of a quality system, not a complete
guarantee of quality.

16. ISO 9001:2015:
ISO 9001:2015 sets out the criteria for a quality management system and is
the only standard in the family that can be certified to (although this is not a
requirement). It can be used by any organization, large or small, regardless
of its field of activity. In fact, there are over one million companies and
organizations in over 170 countries certified to ISO 9001.
ISO 9000 Quality Management Principles:
The ISO 9000:2015 and ISO 9001:2015 standards are based on seven
quality management principles that senior management can apply for
organizational improvement:
1. Customer focus:
 Understand the needs of existing and future customers
 Align organizational objectives with customer needs and expectations
 Meet customer requirements
 Measure customer satisfaction
 Manage customer relationships
 Aim to exceed customer expectations

17. 2. Leadership
 Establish a vision and direction for the organization
 Set challenging goals
 Model organizational values
 Establish trust
 Equip and empower employees
 Recognize employee contributions
3. Engagement of people
 Ensure that people’s abilities are used and valued
 Make people accountable
 Enable participation in continual improvement
 Evaluate individual performance
 Enable learning and knowledge sharing
 Enable open discussion of problems, constraints

18. 4. Process approach
 Manage activities as processes
 Measure the capability of activities
 Identify linkages between activities
 Prioritize improvement opportunities
 Deploy resources effectively
5. Improvement
 Improve organizational performance and capabilities
 Align improvement activities
 Empower people to make improvements
 Measure improvement consistently
 Celebrate improvements
6. Evidence-based decision-making
 Ensure the accessibility of accurate and reliable data
 Use appropriate methods to analyse data
 Make decisions based on analysis
 Balance data analysis with practical experience

19. 7. Relationship management
 Identify and select suppliers to manage costs, optimize resources, and
create value Establish relationships considering both the short and
long term
 Share expertise, resources, information, and plans with partners
 Collaborate on improvement and development activities
 Recognize supplier successes
ISO 9000 vs. 9001
ISO 9000 is a series, or family, of standards. ISO 9001 is a standard within
the family. The ISO 9000 family of standards also contains an individual
standard named ISO 9000. This standard lays out the fundamentals and
vocabulary of quality management systems (QMS).

20. ISO 9000 Series standards
The ISO 9000 family contains these standards:
• ISO 900-Quality management and quality assurance standards guidelines
• ISO 9001-Model for quality assurance in design and development,
production, installation and servicing
• ISO 9002-Model for quality assurance in production and installation
• ISO 9003-Model for quality assurance and final inspection and test
• ISO 9004-Quality management and quality system elements, guidelines on
how to implement a quality program

21. History & revisions:
• Originally published in 1987 by the International Organization for
Standardization (ISO),a specialized international agency for
standardization composed of the national standards bodies of more than
160 countries
• Underwent major revision in 2000; revised again in 2008
• Current versions of ISO 9000 and ISO 9001 were published in September
2015

22. ISO 9000 OBJECTIVES
It defines quality system standards.
1) To meet five objectives
2) Achieve, maintain and seek to continuously improve product quality
[including services] in relationship to requirements
3) Improve the quality of operations
4) Provide confidence to internal management
5) Provide confidence to customers
6) Provide confidence that quality system requirements are fulfilled