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Garnpimol C. Ritthidej
Faculty of Pharmaceutical Sciences
Chulalongkorn University
Garnpimol C. Ritthidej
• Industrial pharmacy is a discipline which includes
manufacturing, development, marketing and
distribution of drug products including quality
assurance of these activities .
Garnpimol C. Ritthidej
Industrial pharmacy (the pharmaceutical industry)
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• 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.
Garnpimol C. Ritthidej
(63% in 2008)
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Best selling drugs
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• More off-patent small molecule products lead to
higher use in generics and relocated production to
the emerging markets.
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*
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insulin
growth hormone
erythropoietin calcitonin
Garnpimol C. Ritthidej
Inherent difficulties exist in biopharmaceutical
formulation as
Garnpimol C. Ritthidej
• More off-patent small molecule products lead to
higher use in generics and relocated production to the
emerging markets.
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CR
1
5
Drug
targeting
SR
oral TDDS
*
2
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GLOBAL MARKET FOR DRUG DELIVERY PRODUCTS,
($ BILLIONS)
http://www.bccresearch.com/pressroom/phm/global-market-advanced-drug-delivery-systems-reach-$196.4-billion-2014
Garnpimol C. Ritthidej
Drug delivery systems
Osmotic type
Reservoir type
Matrix type
Iontophoretic
patch
Transdermal patch
Garnpimol C. Ritthidej
Drug delivery systems
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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.
Garnpimol C. Ritthidej
• 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.
Garnpimol C. Ritthidej
WHO good manufacturing practices:
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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)
Garnpimol C. Ritthidej
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
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ICH Guidelines
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Quality Guidelines
•/
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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
Garnpimol C. Ritthidej
• 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.
Garnpimol C. Ritthidej
Quality by design
(QbD)
Garnpimol C. Ritthidej
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”
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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.
Garnpimol C. Ritthidej
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.
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Producing Small Batch Sizes
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Good distribution practice ( GDP)
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• 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.
Garnpimol C. Ritthidej
THANK YOU
Garnpimol C. Ritthidej