Advances in Pharmaceutical Industry For Wellness and Sustainable Health

ADVANCES IN PHARMACEUTICAL INDUSTRY FOR
WELLNESS AND SUSTAINABLE HEALTH
Garnpimol C. Ritthidej
Faculty of Pharmaceutical Sciences
Chulalongkorn University
• Industrial pharmacy is a discipline which includes
manufacturing, development, marketing and
distribution of drug products including quality
assurance of these activities .
• Statutory provisions in some countries may

require that these certain functions be performed
by pharmacists and may have contact areas with
engineering and economics.
Industrial pharmacy (the pharmaceutical industry)
The main activities of pharmaceutical industry are

• Research and development
• Manufacture and quality assurance
• Drug information
• Patent applications and drug registration
• Clinical trials and post-marketing surveillance
• Sales and marketing
• Management
• Global annual spending on pharmaceuticals is
accordingly increasing and set to reach more
than one trillion U.S. dollars in the next few
years. This is due to population growth, rising
incomes, growth of chronic diseases and
improved access to drugs.
(63% in 2008)
NCDs= non communicable diseases, CVD = cardiovascular diseases

• As advances in technology and understanding of
biological systems and the pathophysiology of
diseases lead the drug development to targeted
therapies at the molecular level.
• Parallelly, knowledge on sequencing of the human
genome allows rapid cloning and synthesis of large
amount of purified proteins. High throughput
screening of large compounds libraries is used
against isolated biological targets in a process known
as reverse pharmacology. Hits from these screens
are then tested in cells and animals for efficacy.
• Thus new FDA-approved products are more biologics
with fewer small and highly potent molecules while
preventive medicines such as vaccines are
increasingly emphasized and in demanding.
Best selling drugs
• More off-patent small molecule products lead to
higher use in generics and relocated production to
the emerging markets.
• Targeted drug delivery using functionalized

micro/nano pharmaceutical carriers can improve drug
safety and efficacy.
*
insulin
growth hormone
erythropoietin calcitonin
Inherent difficulties exist in biopharmaceutical
formulation as
1.The molecules have large molecular weights,

are heterogenous mixtures, may be unstable
following temperature changes or light exposure.
2.Have complex properties (e.g. tertiary

structures).
2 In addition, natural variability exists as they

are produced in living cells.
3 Large scale production of commercially viable

quantities of drug is therefore challenging.
• More off-patent small molecule products lead to
higher use in generics and relocated production to the
emerging markets.
• Targeted drug delivery using functionalized

micro/nano pharmaceutical carriers can improve
drug safety and efficacy.
CR
1
5
Drug
targeting
SR
oral TDDS
*
2
GLOBAL MARKET FOR DRUG DELIVERY PRODUCTS,
($ BILLIONS)
http://www.bccresearch.com/pressroom/phm/global-market-advanced-drug-delivery-systems-reach-$196.4-billion-2014
Drug delivery systems
Osmotic type
Reservoir type
Matrix type
Iontophoretic
patch
Transdermal patch
Drug delivery systems
Nasal vaccine
• FDA approved live cold-
adapted trivalent influenza
vaccine (FluMistTM
Medimmune, Gaithersburg,
MD) is administered via a
prefilled single-use device
that sprays vaccine into
the nostrils.
• The virus is unable to
replicate effictively
outside the nasopharyngeal
epithelial cells.
• To keep pace with these advances, stringent in
manufacturing of these products are required. By
international regulations, the standards of PIC/S
GMP have been now implemented and required for
quality assurance of the products while ICH
guidelines are essentially recommended. Risk
assessment has come to play an important role in
WHO quality assurance guidelines.
• Moreover, due to a rising demand for quality and

safety, process analytical and inspection technologies,
continue process verification and quality by design
with design engineering on processing and packaging
of pharmaceuticals and biologics must be with the
utmost caution.
WHO good manufacturing practices:
•WHO good manufacturing practice for pharmaceutical products:

main principles (Annex 2, WHO Technical Report Series 986, 2014)
•Active pharmaceutical ingredients (bulk drug substances) (Annex

2, WHO Technical Report Series 957, 2010
•Pharmaceutical excipients (Annex 5, WHO Technical Report Series 885,

1999)
•WHO good manufacturing practices for sterile pharmaceutical

products (Annex 6, WHO Technical Report Series 961, 2011)
•Biological products (Annex 3, WHO Technical Report Series 822, 1992)
•WHO good manufacturing practices for blood establishments

(jointly with the Expert Committee on Biological Standardization)
(Annex 4, WHO Technical Report Series 961, 2011)
•Pharmaceutical products containing hazardous substances (Annex
3 WHO Technical Report Series 957, 2010)
•Investigational pharmaceutical products for clinical trials in

humans (Annex 7, WHO Technical Report Series 863, 1996)
•Herbal medicinal products (Annex 3, WHO Technical Report Series 937,

2006)
•Radiopharmaceutical products (Annex 3, WHO Technical Report Series

908, 2003)
•Water for pharmaceutical use (Annex 2, WHO Technical Report Series

970, 2012)
•WHO guidelines on good manufacturing practices for heating,

ventilation and air-conditioning systems for non-sterile
pharmaceutical dosage forms (Annex 5, WHO Technical Report Series
961, 2011)
•Validation (Annex 4, WHO Technical Report Series 937, 2006)
Risk analysis
•Application of Hazard Analysis and Critical Control
Point (HACCP) Methodology in Pharmaceuticals (Annex 7,
WHO Technical Report Series 908, 2003)
Technology transfer
•WHO guidelines on transfer of technology in
pharmaceutical manufacturing (Annex 7, WHO Technical
Report Series 961, 2011)
PIC/S (Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Co-operation Scheme)
are two international instruments between
countries and pharmaceutical inspection
authorities, which provide together an active and
constructive co-operation in the field of GMP.
• PIC/S GMP GUIDE
• SITE MASTER FILE FOR PLASMA WAREHOUSES

• PIC/S GMP GUIDE (INTRODUCTION)
• PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR

MEDICINAL PRODUCTS)
• PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE

PHARMACEUTICAL INGREDIENTS)
• PIC/S GMP GUIDE (ANNEXES)
ICH Guidelines
The ICH (International Conference on

Harmonization) topics are divided into four
categories
1. General principle on planning/designing Multi-
Regional Clinical Trials
2. Quality guidelines
3. Safety guidelines
4. Efficacy guidelines
Quality Guidelines
•/
Harmonisation achievements in the Quality area include

pivotal milestones such as the conduct of stability studies,
defining relevant thresholds for impurities testing and a more
flexible approach to pharmaceutical quality based on GMP risk
management.
o Q1A - Q1F Stability

oQ2 Analytical Validation
oQ3A - Q3D Impurities
oQ4 - Q4B Pharmacopoeias
oQ5A - Q5E Quality of Biotechnological Products
oQ6A- Q6B Specifications
oQ7 Good Manufacturing Practice
oQ8 Pharmaceutical Development
oQ9 Quality Risk Management
oQ10 Pharmaceutical Quality System
oQ11 Development and Manufacture of Drug Substances
Safety Guidelines
•/
ICH has produced a comprehensive set of safety

Guidelines to uncover potential risks like carcinogenicity,
genotoxicity and reprotoxicity. A recent breakthrough has
been a non-clinical testing strategy for assessing the QT
interval prolongation liability: the single most important cause
of drug withdrawals in recent years.
oS1A - S1C Carcinogenicity Studies

oS2 Genotoxicity Studies
oS3A - S3B Toxicokinetics and Pharmacokinetics
oS4 Toxicity Testing
oS5 Reproductive Toxicology
oS6 Biotechnological Products
oS7A - S7B Pharmacology Studies
oS8 Immunotoxicology Studies
oS9 Nonclinical Evaluation for Anticancer Pharmaceuticals
oS10 Photosafety Evaluation
Efficacy Guidelines
•/
The work carried out by ICH under the Efficacy heading is
concerned with the design, conduct, safety and reporting of
clinical trials. It also covers novel types of medicines derived
from biotechnological processes and the use of
pharmacogenetics.
oE1 Clinical Safety for Drugs used in Long-Term Treatment

oE2A - E2F Pharmacovigilance
oE3 Clinical Study Reports
oE4 Dose-Response Studies
oE5 Ethnic Factors
oE6 Good Clinical Practice
oE7 Clinical Trials in Geriatric Population
oE8 General Considerations for Clinical Trials
oE8 General Considerations for Clinical Trials
oE9 Statistical Principles for Clinical Trials
oE10 Choice of Control Group in Clinical Trials
oE11 Clinical Trials in Pediatric Population
oE12 Clinical Evaluation by Therapeutic Category
oE14 Clinical Evaluation
oE15 Definitions in Pharmacogenetics / Pharmacogenomics
oE16 Qualification of Genomic Biomarkers
oE17 Multi-Regional Clinical Trials
oE18 Genomic Sampling Methodologies
• To keep pace with these advances, stringent in
manufacturing of these products are required. By
international regulations, the standards of PIC/S
GMP have been now implemented and required for
quality assurance of the products while ICH
guidelines are essentially recommended. Risk
assessment has come to play an important role in
WHO quality assurance guidelines.
• Moreover, due to a rising demand for quality and

safety, process analytical and inspection
technologies, continue process verification and
quality by design with design engineering on
processing and packaging of pharmaceuticals and
biologics must be with the utmost caution.
Quality by design
(QbD)
PAT (“Process Analytical Technology”) is
defined as “one system for designing, analyzing
and checking production processes, based on
measuring critical-to-quality attributes (CQA)
of raw materials, in-process materials and
production processes in real time, with the aim
of optimizing the process and ensuring the
quality of the end product”
A vial inspection machine A new generation of fully automated inspection
machines by the Inspection Technology sector of Bosch Packaging
Technology following the acquisition of Eisai Machinery. It is to detect
moving particles in pharmaceutical liquid by use of an optical sensor.
Managing High-potency Substances:
Due to the increased use of highly potent and cytotoxic
substances, manufacturers pay more attention to protecting all
elements of the supply chain from their potentially harmful
effects using containment and isolator systems.
Producing Small Batch Sizes
Smaller batch sizes of

personalized medicine shift the
emphasis from speed and mass
production of standard dosage
products to more individualized
products packaged in high-quality
materials.
Short start-up times, easy

changeovers and a high degree of
automation are key
considerations.
Good distribution practice ( GDP)
• Consequently, the profession of industrial
pharmacist becomes more responsible, more
challenging, more diversified and needs new
knowledge towards the wellness and
sustainable health of mankind.
THANK YOU

Advances in Pharmaceutical Industry For Wellness and Sustainable Health

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ADVANCES IN PHARMACEUTICAL INDUSTRY FOR

WELLNESS AND SUSTAINABLE HEALTH

• Statutory provisions in some countries may

The main activities of pharmaceutical industry are

NCDs= non communicable diseases, CVD = cardiovascular diseases

• Targeted drug delivery using functionalized

1.The molecules have large molecular weights,

2.Have complex properties (e.g. tertiary

2 In addition, natural variability exists as they

3 Large scale production of commercially viable

• Targeted drug delivery using functionalized

• Moreover, due to a rising demand for quality and

•WHO good manufacturing practice for pharmaceutical products:

•Active pharmaceutical ingredients (bulk drug substances) (Annex

•Pharmaceutical excipients (Annex 5, WHO Technical Report Series 885,

•WHO good manufacturing practices for sterile pharmaceutical

•Biological products (Annex 3, WHO Technical Report Series 822, 1992)

•WHO good manufacturing practices for blood establishments

•Investigational pharmaceutical products for clinical trials in

•Herbal medicinal products (Annex 3, WHO Technical Report Series 937,

•Radiopharmaceutical products (Annex 3, WHO Technical Report Series

•Water for pharmaceutical use (Annex 2, WHO Technical Report Series

•WHO guidelines on good manufacturing practices for heating,

•Validation (Annex 4, WHO Technical Report Series 937, 2006)

• SITE MASTER FILE FOR PLASMA WAREHOUSES

• PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR

• PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE

The ICH (International Conference on

Harmonisation achievements in the Quality area include

o Q1A - Q1F Stability

ICH has produced a comprehensive set of safety

oS1A - S1C Carcinogenicity Studies

oE1 Clinical Safety for Drugs used in Long-Term Treatment

• Moreover, due to a rising demand for quality and

Smaller batch sizes of

Short start-up times, easy

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