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INDUSTRIAL PHARMACY
GMP for Pharmaceutical Products

Wayan Redja
FACULTY OF PHARMACY INSTITUTE OF SCIENCE AND TECHNOLOGY
JAKARTA

2021
 INDUSTRIAL PHARMACY
GMP for Pharmaceutical Products

 INTRODUCTION
 QUALITY MANAGEMENT SYSTEM
 RESOURCES
 PRODUCTION
 QUALITY CONTROL AND QUALITY ASSURANCE
 AIR HANDLING UNIT
 WATER TREATMENT SYSTEM
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 INTRODUCTION

 OBJECTIVES
 EFFECTIVE LEARNING METHOD
 PHARMACY
 INDUSTRY
 INDUSTRIAL PHARMACY VS PHARMACEUTICAL INDUSTRY
 GMP AND ASPECTS OF GMP

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 INTRODUCTION

 OBJECTIVES Students can explain about What, Why and How?

 EFFECTIVE LEARNING METHOD
Passion, Focus, Repetition, Sharing, Practice!
 PHARMACY
The clinical health science and technology that link medical science with
chemistry and other natural sciences. It is in charged with the discovery,
production, distribution, safe and effective use, control of pharmaceutical
products and medication. (Wikipedia, modified)
# Pharmacy = profession = place (Apotheke) WR03
 INTRODUCTION

 INDUSTRY

What? Group of companies with similar type of operations, e.g. trade

and/or manufacturing, or services. Larger groups are called
sectors.

Why? To fulfil a wide and/or many demands in time.

How? Follow the regulations > provide the required facilities and other
resources > set up the appropriate management system > and
operate accordingly. WR04
 INTRODUCTION

 INDUSTRIAL PHARMACY VS PHARMACEUTICAL INDUSTRY

INDUSTRIAL PHARMACY
What? A discipline of Pharmaceutical Science and Technology which include discovery,
development, manufacturing, marketing and distribution of pharmaceutical
products including quality assurance of these activities and the products.
Why? To assure the development and manufacturing processes of the quality standard
pharmaceutical products are carried out effectively and efficiently.
How? 1. Understand GMP and the discipline of Pharmaceutical Science and Technology
in the development and manufacturing of the quality standard products.
2. Practice the effective learning method.
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 INTRODUCTION

 INDUSTRIAL PHARMACY VS PHARMACEUTICAL INDUSTRY

PHARMACEUTICAL INDUSTRY
What? Industry with regard to pharmaceuticals.
Why? To fulfil high demand of the pharmaceutical products.
How? 1. The provision of assured quality standard pharmaceutical products by
manufacturing or purchasing of the products.
2. To establish pharmaceutical industry
3. Follow the regulations, set up appropriate quality management system,
provide adequate resources, practice GMP and GDP and the pharmaceutical
science and technology in manufacturing and distribution of pharmaceuticals.
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 INTRODUCTION

 GMP AND ASPECTS OF GMP

GMP Good Manufacturing Practices (
> GMP for Pharmaceutical Products (CPOB), > GMP for Active Pharmaceutical Ingredient
(CPBBOB),> GMP for Traditional Medicine (CPOTB),> GMP for Cosmetic (CPKB),

Definition of CPOB
Regulation issued by BPOM on GMP for Pharmaceutical Products as part
of QA which ensure that the products are consistently produced and controlled to the
quality standards appropriate to their intended use and as required by the marketing
authorization.
# quality standards = specified quality = specification. (WHO, Technical Report Series, No.961, 2011)
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 INTRODUCTION

Why GMP?
 To assure the quality of pharmaceutical products meet the quality standards
according to their intended use..
 To follow the regulations, e.g. CPOB, drug registration, etc.
 To avoid errors due to:
> cross contamination, > resource error,
> product degradation, > process run error,
> mix up, > health hazard.
 To assure the quality of pharmaceutical products fulfill the requirements
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 INTRODUCTION

HOW TO IMPLEMENT GMP?

 Follow the regulations / Good Practices in Pharmacy.
 Follow the QM/QA principles:
> Build quality into the products.
> Do it right from the first time and every time.
> Follow the PDCA cycle on “GMP Process Flow”.
> Write what will be done , do what is written , and write what is done.
> In Process Control, review, CAPA / continual improvement.
 Follow the “FDA’s Quality System Guidance.”
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 Seven Critical Concepts of the FDA’s Quality System
Guidance
Modern Quality System in CGMP
 Quality > the strength, purity, and other characteristics to ensure a drug product’s safety and
effectiveness.
 Quality by Design (QbD) and Product Development > designing & developing a product
and its manufacturing processes to ensure that the product consistently attains predefined quality
 Quality Risk Management > assessing the risk of quality issues, selecting and implementing
QRM, evaluating the results of the risk management efforts.
 CAPA > investigating, understanding, correcting discrepancies to prevent their recurrence.
 Change Control > to prevent unintended consequence.
 Quality Unit > promotes quality in general practice.
 Six-System Inspection Model > 1. quality, 2. production, 3. facilities and equipment, 4.
laboratory controls, 5. materials, and 6. packaging & labelling,

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 INTRODUCTION

 ASPECTS OF GMP Management (1)

 Quality Management

Resources (4) Processes (7) Annex (13)

 Personnel  Production  Toll Manu-  Mfg of: sterile product,
 Premises  Quality control material & biological
facturing
product, medicinal gas,
& Facilities  GSP & GDP  Validation aerosol, blood product,
 Equipment  Self Inspection and Qualifi- drug for clinical studies,
 Documenta-  Handling of cation GMP of API, radiopharma-
tion Complaint and ceuticals, use of ionizing
radiation in drug mfg (9)
product recall  real time and parametric
release, reference and
retained samples, QRM,
computerized system (4).

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THANK YOU