Author is a well experienced Regulatory Professional submitted DMFs and Dossiers to Regulated markets. worked with Lupin, Granules india, IPCA subsidory kerbs , Biological E ltd , SFC chemicalsLtd a USA based company and hosted many a FDA, EDQM and EU GMO as well as MFDS korean audits .let the pharma professionals take the benefit of this PPT. contact on 7780307302 and eamil: info.intertechlabs@gmail.com

1. Module-I
Familiarization
to
Pharmaceutical Industry
1
Presented by
T. Raja Rao M.Sc.,LLM
7780307302
DIRECTOR
Info.intertechlabs@gmail.com

2. 2
 Human health protection and promotion needs to be taken
care by the respective governments of the territories and United
Nations. Hence, Regulatory Authorities were created and established
over a period of time.
 To prevent the diseases and disorders. Drugs are needed which are categorized
mainly into 2 classes.
1. Preventive medicine (e.g: Vaccines)
2. Drugs used for therapy (e.g: Anti-biotics e.t.c)

3. 3
 Drugs cannot be manufactured like article of commerce. Hence, regulatory bodies
were created and established to frame the laws and guidelines to establish the
manufacturing industries to establish, produce and distribute the drugs.
 The drug regulatory Authorities nomenclature are different among the countries and
regions within the country as the case may be.
 The industries that produce and distribute the bulk drugs, dosage form via synthetic
route, semi-synthetic route, classical fermentation and natural sources or bio process
based are categorized as pharmaceutical industries.

4. 4
 The pharmaceutical industry in India is about US$ 10 bn worth market, increasing
annual rate of 9%.
 The domestic industry stands fourth in terms of volume and 13th in value terms.
 Pharma companies have developed Good Manufacturing Practices (GMP) compliant
facilities for the production of APIs & dosage forms.
 In addition to GMP, WHO, several Indian companies have also been getting plant
approvals from international regulatory agencies like;
US FDA,
MCA (UK),
TGA (Australia),
MCC (South Africa).

5. 5
India possesses the highest number of US FDA approved manufacturing facilities outside
the USA and currently tops in filing the drug master files in CTD with the US FDA
Production of generics of the new patented molecules without license/payment of royalty
to the innovator company is not possible.
Estimated to have over 10,000 manufacturing units within India. The organized sector
accounts for just 5% of the industry with around 300 players . Small and medium
enterprises and this segment contributes 35% of the industry’s turnover.

6. 6
The Regulatory Control of the Pharmaceutical Industry

7. 7
 Growing orientation towards Research and Development (R&D)
 Leveraging CRAMs opportunities
 Growing exports
 Expanding presence in regulated market
 Rise in new product launches
 The Regulatory Control of the Pharmaceutical Industry
Growing exports Expanding presence in regulated market

8. 8
 The global pharmaceuticals market is worth US$ 860 billion a year,
 The USA pharmaceuticals market is worth US$ 360 billion a year,
 The EU pharmaceuticals market is worth US$ 225 billion a year,
 The ROW pharmaceuticals market is worth US$ 140 billion a year,
 The Emerging market pharmaceuticals market is worth US$ 200 billion a year,
-1/3 sales revenue spent on marketing which amounts double revenue spent on R&D
- Oncologic and Analgesics were the top selling therapeutic classes
1 billion USD = About 5500 crores of INR
2014:
prescription drug sales Pfizer company stand as No.1 & Novartis No. 2 by worldwide
2018 projections:
prescription drug sales Novartis company stand as No.1 & Pfizer No. 2 by worldwide
R&D spend forecast is about $124bn, Expected to become $150bn by 2018

9. 9
Projection of sales & therapeutic categories from 2014-2018

10. 10
 Indian pharmaceutical market is among the top five emerging pharmaceutical markets
The following trends influence the growth of the market:
1. Doubling of disposable incomes and the number of middle-class households
2. Expansion of medical infrastructure
3. Greater penetration of health insurance
4. Rising prevalence of chronic diseases
5. Adoption of product patents
6. Aggressive market penetration driven by the relatively smaller companies
 Increasing sales of generic medicines, continuing growth of chronic therapies, and greater penetration
in rural markets also contribute to the increase in revenue sales
 Indian pharma companies have taken advantage of the generics expiries and the increasing demand
for low-cost drugs, which has been conducive for the growth in the industry
 Global demand for Indian generics is increasing due to rise in healthcare costs in developed countries
 Indian generics companies are set to focus on under-penetrated markets like France, Italy and Spain
and branded generic markets in East Europe, including complex generics, OTCs, etc.

11. 11
With 72% of market share (in terms of revenues), generic drugs form the largest segment of
the Indian pharmaceutical sector.

12. 12

13. 13
Technical functionaries existing in the Pharmaceutical Company
Production
PR&D
QA
Purchase
Mkt/BD
QC
RA
Eng.
&
Proj
TTD
P.Eng
EDP
HR
PPC
SCM
WH

14. 14
Departments
Research and Development:
“The objective is to find the most efficient, streamlined and cost-effective methods for producing
materials at an industrial scale, and then synthesize those materials for industrial validation.”
Research &
Development
Researchers start their scale-up research in the process research and development lab.

15. 15
There are several sub functionalities in the area of Research & Development
Research &
Development
CRO
Plant R&D
R&D
Research and Development:

16. 16
Research &
Development
R&D
Drug Development Stages:

17.  The success of pharmaceutical companies is completely depends on drug discovery.
 It involved great amount of time and money.
 The highly successful companies have a great teams dedicated for R&D, who are continuously
keeping their efforts to build and develop new molecules or medicines.
Drug Discovery Process & Involvement
Quality, Safety, Efficacy & Post marketing surveillance
17
Drug discovery process from target ID and validation through to filing of a compound and the approximate
timescale for these processes. FDA, Food and Drug Administration; IND, Investigational New Drug; NDA, New
Drug Application.

18. 18
Supply Chain Management:
Research &
Development
R&D
More difficult than manufacturing
Does not focus on the flow of physical goods
Focuses on human resources and support services
More compact and less extended

19. 19
Supply Chain Management:
Research &
Development
R&D

20. 20
Supply Chain Management:
Research &
Development
R&D
Coordinated workflow, production and operations, procurement
Production efficiencies
Fast response
Improved service
Quicker to market
Adopt new business models and technologies
Penetration of new markets
Creation of new products
Improved efficiency
Mass customization

21. 21
Purchase:
Research &
Development
R&D
1.TO HAVE A GLANCE ON STOCK POSITION:
Stock record is so maintained that at a minimum stock position of material, a new order for purchase can be made.
Purchase order should be made at a time so that you are not run off the material before receiving the material purchased.
2.PROCESSING THE PURCHASING ORDER:
It should contain all specifications about the ordered material i.e. powder form, color pack, weight, etc.
3.SELECTION OF SUPPLIERS:
4.PLACING OF ORDERS:
5.FOLLOW-UP OF PURCHASE ORDER:
6.INVOICES RECEIVED FROM SUPPLIERS ARE CHECKED AND VERIFIED 7.WITH THE ORDER SPECIFICATIONS.

22. 22
Human Resources (HR):
Research &
Development
R&D
 Utilization of individuals to achieve organizational objectives.
 All managers at every level must concern themselves with human resource management
 Five functions
1
Human
Resource
Management
Safety and
Health

23. 23
Human Resources (HR):
Staffing - Process through which organization ensures it always has proper number of employees
with appropriate skills in right jobs at right time to achieve organizational objectives
Job analysis - Systematic process of determining skills, duties, and knowledge required for
performing jobs in organization
Human resource planning - Systematic process of matching the internal and external supply of
people with job openings anticipated in the organization over a specified period of time
.
Recruitment - Process of attracting individuals on a timely basis, in sufficient numbers, and with
appropriate qualifications, to apply for jobs with an organization
Selection - Process of choosing from a group of applicants the individual best suited for a particular
position and the organization
Training
Development
Career Planning
Career Development
Organizational Development
Performance Management
Performance Appraisal

24. 24
Ware house:
R&D
Maintaining proper storage conditions for pharmaceutical products is vital to ensure their quality, safety and efficacy
Factory stores will invariably be receiving duly approved raw materials and packaging materials from third party.
A suitable space is provided to raw material, handling of raw & packaging materials required for manufacturing,
including packaging of pharmaceuticals. This space is known as Ware House.
There are mainly 3 stages;
1. Purchase
2. Storage
3. Distribution
Various areas of Warehouse;
1. Receiving Area: Includes initial inspection, cleaning & weight checking
2. Sampling Area: With adequate facilities to prevent cross contamination
3. Storage Area: Including specific storage like air condition rooms, cold rooms, hazardous chemical storage room.
4. Rejected materials Area: Destroy or returned unsuitable.
5. Dispensing Area: With adequate facilities to preclude cross contamination during dispensing.

25. 25
Ware house:
R&D
Good Warehouse Practices
1. Premises
2. Security
3. Temperature and humidity control
4. Equipment
5. Personnel
6. Sanitation
7. Receipt of incoming goods
8. Assembling orders and issuing goods
9. Packing for transportation
10. Transport

26. 26
Water system:
R&D
Background to water requirements and its use
Water is the most widely used substance / raw material
Used in production, processing, formulation, cleaning, quality control
Different grades of water quality available
Design, installation, commissioning, qualification / validation, operation, performance and maintenance to ensure
reliable, consistent production of water of required quality
Operate within design capacity
Prevent unacceptable microbial, chemical and physical contamination during production, storage and distribution
Quality Assurance involved in approval of use after installation and maintenance work
Types of water used in pharmaceutical industry
1. Purified water
2. Water for Injections-PFW & WFI
3. Softened water
4. Water for final rinse
5. Pure or clean steam
6. Water for cooling Autoclaves

27. 27
Water system:
R&D
Typical water storage and distribution schematic
Water
must be
kept
circulatin
g
Spray ball
Cartridge
filter 1 µm
Air break
to drain
Outlets
Hygienic pump
Optional
in-line filter
0,2 µm
UV light
Feed Water
from
DI or RO
Heat Exchanger
Ozone Generator
Hydrophobic air filter
& burst disc

28. 28
Job description & Involvement:
The regulatory professional’s job is to keep track of the ever-changing legislation in all the regions
in which the company wishes to distribute its products. They also advise on the legal and scientific
restraints and requirements, and collect, collate and evaluate the scientific data their research and
development colleagues are generating.
They are responsible for the presentation of registration documents to regulatory agencies, and
carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization
for the products concerned.
They give strategic and technical advice at the highest level in their companies, right from the
beginning of the development of a product, making an important contribution both commercially
and scientifically to the success of a development programme and the company as a whole.
Avoiding problems
It takes anything up to 15 years to develop and launch a new pharmaceutical product and many
problems may arise in the process of scientific development and because of a changing regulatory
environment.
Regulatory professionals help the company avoid problems caused by badly kept records,
inappropriate scientific thinking or poor presentation of data.
The regulatory affairs department will take part in the development of the product marketing
concepts and is usually required to approve packaging and advertising before it is used commercially.
Regulatory Affairs:

29. 29
Regulatory Affairs:

30. 30
Effluent Treatment Plant:
Research &
Development
R&D
 Water is basic necessity of life used for many purposes one of
which is industrial use.
 Industries generally take water from rivers or lakes but they
have to pay heavy taxes for that.
 So its necessary for them to recycle that to reduce cost and
also conserve it.
 Considering these criteria an Effluent Treatment Plant is best
for industries.

31. 31
Effluent Treatment Plant:
Research &
Development
R&D

32. 32
Quality Control (QC):
R&D
 Quality Control involves in sampling, inspecting and testing of starting materials,
in-process , intermediate, bulk and finished products.
 Also includes where applicable, environment monitoring program, review of batch
documentation, sample retention programs, stability studies and maintaining correct
specification of materials and products.
 There shall be a QC laboratory attached to each manufacturing unit.

33. 33
Quality Control (QC):
Research &
Development
R&D
 The laboratory shall be capable of performing all the test in accordance to approve
specification or to perform part of test while sub-contracting part of tests to approved
contract laboratory.
 Where appropriate, QC laboratory shall be separated from production areas
especially from microbiology lab.
 Separate rooms may be necessary to protect sensitive instruments from vibration,
electrical interference, humidity e.t.c.
 Involves in all decisions concern with the product quality.

34. 34
Formulation R&D:
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including
the active drug, are combined to produce a final medicinal product.
Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient.
For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule.
It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and
studies have to be carried out to ensure that the drug is compatible with these other substances.

35. 35
Formulation R&D:
Pre-formulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to
choose what other ingredients (known as excipients) should be used in the preparation.
Formulation studies consider particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability
and hence the activity of a drug.
Formulated drugs are stored in container closure systems for extended periods of time. These include blisters, bottles,
vials, ampules, syringes, and cartridges.
It's important to check whether there are any unwanted interactions between the preparation and the container. For
instance, if a plastic container is used, tests are carried out to see whether any of the ingredients become adsorbed on
to the plastic, and whether any plasticizers, lubricants, pigments, or stabilizers leach out of the plastic into the
preparation.

36. 36
Formulation R&D:

37. 37

38. 38
Job description & Involvement:
The regulatory professional’s job is to keep track of the ever-changing legislation in all the regions
in which the company wishes to distribute its products. They also advise on the legal and scientific
restraints and requirements, and collect, collate and evaluate the scientific data their research and
development colleagues are generating.
They are responsible for the presentation of registration documents to regulatory agencies, and
carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization
for the products concerned.
They give strategic and technical advice at the highest level in their companies, right from the
beginning of the development of a product, making an important contribution both commercially
and scientifically to the success of a development programme and the company as a whole.
Avoiding problems
It takes anything up to 15 years to develop and launch a new pharmaceutical product and many
problems may arise in the process of scientific development and because of a changing regulatory
environment.
Regulatory professionals help the company avoid problems caused by badly kept records,
inappropriate scientific thinking or poor presentation of data.
The regulatory affairs department will take part in the development of the product marketing
concepts and is usually required to approve packaging and advertising before it is used commercially.
Regulatory Affairs:

39. 39
The drug regulatory bodies in various countries/Member states are
named differently. But the roles and responsibilities are more or less same.
1. USA: About 50 states are located within USA and one common
regulatory body does exist for promotion and protection of human
Health named as FDA (Food and Drug Administration).It is basically an
Organization created to assure the human health regulation promotion
and protection. FDA is an organization that contains 8 centres/offices deal with all the categories of APIs
Dosage forms for Pharmaceuticals & Biologics besides Radiological devices, Food, Tobacco products, Toxicology
Reserch and guidance, Vaccinecs, Hrbal products and Natural products of Plant origon, Animal origon, Natual origon
2. EU (European Union): Various countries in EU are called
Member states and the various regulatory bodies are created for
promotion and protection besides operational convenience and synergy.
European commission or Council is the Advisory body of European
Parliament and responsible for creating the legislations, regulations and
Guidelines.
3. Japan: MHLW (Ministry of Health and Labor Welfare) is the regulatory
Body for human health and PMDA (Pharmaceutical and Medical Devices agency) is the agency which
takes care of promotion and protection of Human health under MHLW guidance.
Regulatory bodies over the globe:

40. 40
ICH (International Conference on Harmonization):
It is a tripartite federation formed in 1991, 2 decades ago with an initiative from the EU
 It is also a regulatory body with out having direct authority on any country and does not
approve any MA or Drug applications (New drugs or Generics)
 Objectivity: To harmonize guidelines on various aspects of Quality, Safety and Efficacy w.r.t
registration requirements of pharmaceuticals (Drugs)
 The members in the ICH are EU, USA and Japan.
 The responsibilities include to take up topics for harmonization and publish the guidance
documents under 4 categories.
The alphabet before the numeric's does indicates the category of the topic
1. Q (Quality)
2. S (Safety i.e Clinical safety)
3. E (Efficacy)
4. M (Multidisciplinary). Corner cutting topics included here.

41. 41
Regulatory bodies in EU:
EDQM (European Directorate for the Quality of Medicines)
 This is located in Strasburg, France in EU. It is centralized body created by European council
for the following activities
1. Publication of EP
2. Publication of general guidance documents
3. Issuance of CEP (Certificate of Suitability confirms the European Pharmacopeia
monographs)
4. Technical & scientific Counseling & training
 They will not issue any Marketing authorization directly.
 They issue only CEP, which is certification for conformance for technical & scientific aspects of
the EP monograph pertinent molecules & products.
 They will not issue any CEP for non-EP monographic products. Precisely for the generic and
established products only CEPs are issued by EDQM.
 By submitting the CEP along with MAA (Marketing Authorization Application), MA (Marketing
Authorization )can be obtained by the applicants

42. 42
Regulatory bodies in EU:
EMeA or EMA(European Medicines Agency):
 This is also a centralized body works under the directives of EC to issue MA directly subject to
compliance of NRA procedures of respective countries by evaluating technical & scientific
aspects of the molecules.
 The responsibilities include promotion and protection of health that includes
1. Review and approval of the MA that are acceptable to all the member states of EU
2. To publish the technical & scientific aspects of the pharmaceuticals
3. To coordinate, arbitrate among the regulatory bodies of member states in EU
4. Counseling and training
 This EMeA is a centralized body with decentralized procedures. Since, it is represented by the
members of each NRA who will participate in various committees.
The committees include
1. Committee for Medicinal Products for Human Use (CHMP)
2. Pharmacovigilance Risk Assessment Committee (PRAC)
3. Committee for Medicinal Products for Veterinary Use (CVMP)
4. Committee for Orphan Medicinal Products (COMP)
5. Committee on Herbal Medicinal Products (HMPC)
6. Committee for Advanced Therapies (CAT)
7. Pediatric Committee (PDCO)
 The MA for all products will not be issued at EMeA.
 This agency will consider 5-6 categories of drugs which will be further discussed in detailed.

43. 43
Regulatory bodies in EU:
NRA(National Regulatory Authority):
 Each member state of EU does have a NRA & works for promotion and protection of health
under some limitations and constraints. Hence, dependency on centralized bodies for synergy
effect.
 Each member state does have the authority to issue MA for new drugs as well as generic
drugs (Abridged Applications) directly.
 Resources and infrastructure is the constraint and since the MA issued by NRA has a validity
within the member state hence, duplication of job will be done to introduce the more science
into the other member states.
 Benefit of Centralized MA issued by EMeA & EDQM cannot be happened.
 After issuance of MA by EMeA then national procedures of labeling, SPC e.t.c in the local
language of the member state to be applied for issuance of MA in respective country.

44. 44
Drug Regulatory Affairs
Focus:
• Regulatory affairs personnel are the first-line assurance that company products and
documentation are in accordance with concern regulatory bodies worldwide.
• The Professional Program in Regulatory Affairs reviews FDA regulations and other guidelines, Good
Pharmaceutical Practice (GXP) principles and ethical considerations
Ensure that the development of drugs and dossiers for clinical trials and licensure, and provides the
training to manage these activities.
Definition:
Regulatory affairs is a comparatively new profession which developed from the desire of
governments to protect public health by controlling the safety and efficacy of products in areas
including pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary
medicines. The companies responsible for the discovery, testing, manufacture and marketing of
these products also want to ensure that they supply products that are safe and make a worthwhile
contribution to public health and welfare.

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Thanking You….