Intro Flashcards by Marah Joy M. FLORES

• The manufacture, propagation, preparation and processing of a drug product in a large scale
• The making by physical, chemical, biological or any procedure of any article that meets the definition of
drugs

Pharmaceutical Manufacturing

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• The manipulation, sampling, testing or control procedures applied to the final product or any other part of the process
• The packing, repacking or changing the container, wrapper or label of any drug package in preparation for its distribution from the manufacturer to the final user.

Pharmaceutical Manufacturing

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Areas of Manufacturing:

Manufacture of API and Excipients
Manufacture of finished dosage form
Packing, labeling, repacking of finished bulk

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are bulk products that are pharmaceutically active and generate a desired pharmacological effect.

API

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are pharmacologically non active substances that are
generally used as a carrier of the API in the drug.

Excipients

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Types of Drug Establishments:

Drug Manufacturer
Drug Trader
Drug Distributor

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Any establishment engaged in operations involved in the production of drugs.

Drug Manufacturer

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Types of Drug Manufacturer

a. Ethical Manufacturer
b. proprietary/Generic Manufacturer
c. Biologicals manufacturer
d. Veterinary Products manufacture
e. Medical Chemical manufacturer
f. Toll/Contract Manufacturer

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registered owner of the drug product but contracts toll manufacturers

Drug Trader

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Agreement whereby a competent company processes a raw materials or semi-finished goods or package products for another company.

Toll Manufacturing

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Import raw materials or finished products from other countries for distribution to drug outlets.

Drug Importer

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Exports raw materials or finished products to be distributed to other countries.

Drug Exporter

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Acquire raw materials or finished products from local establishment distributed on a wholesale basis.

Drug Wholesaler

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TOP PHARMACEUTICAL INDUSTRY in The Philippines:

Boehringer Ingelheim
gsk
Abbott
Pfizer
Unilab

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DEPARTMENTS IN DRUG ESTABLISHMENTS:

WAREHOUSE
RESEARCH DEPARTMENT
PRODUCTION/MANUFACTURING DEPARTMENT
QUALITY CONTROL DEPARTMENT
ENGINEERING DEPARTMENT
PRODUCTION CONTROL DIVISION
MEDICAL DEPARTMENT
MARKETING DEPARTMENT
ADMINISTRATION
REGULATORY DEPARTMENT

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– RM and PM section
• Quarantined materials (yellow)
• Approved for use materials (green)
• Rejected materials (red)
– In-Process
– Finished Products/Goods
– Returned Goods
– Dispensing

WAREHOUSE

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– Develops products to be marketed by the company
– Library, animal house, pilot plant

RESEARCH DEPARTMENT

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– Manufacturing of drug products

PRODUCTION/MANUFACTURING DEPARTMENT

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– Heart and soul of the drug products
– Ensures that the materials, products and processes in the manufacture of the products are in accordance with the predetermined quality characteristics
– Sampling, testing, assaying of drugs

QUALITY CONTROL DEPARTMENT

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– Locates, installs, repair, maintains equipment
– Ensures plant and personnel

ENGINEERING DEPARTMENT

– Purchasing department
– Inventory control
– Planning and scheduling

PRODUCTION CONTROL DIVISION

– Physical and medical examination of employees and applicants

MEDICAL DEPARTMENT

– Sales of products creates the demand for the products
– Prepare product inserts and literatures, publishes newsletter

MARKETING DEPARTMENT

– Determines the overall direction of the company and takes care of the day-to-day operations of the company

ADMINISTRATION

– Liaises with the regulatory bodies on the registration of the company and its product

REGULATORY DEPARTMENT

• Systems for ensuring that products are consistently produced and controlled according to quality standards (AO 43 s 1999)

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)

• Designed to minimize the risk/errors involved in any pharmaceutical production that cannot be eliminated through testing the final product.

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)

• Part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use ( WHO, 2007) • Gives manufacturer’s license to operate upon compliance with cCGMP.

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)

To produce a product that is pure, safe and effective.

CURRENT GOOD MANUFACTURING PRACTICES (cGMP) Objective:

section of manufacturer that is responsible for establishing process and product specifications.

CURRENT GOOD MANUFACTURING PRACTICES (cGMP) Quality Control:

group within the manufacturer that determines that the systems and facilities are adequate, and that the written procedures are followed.

CURRENT GOOD MANUFACTURING PRACTICES (cGMP) Quality Assurance:

adaptation of the first edition of the cGMP Guidelines by BFAD

AO 43 s. 1999

adaptation and implementation of the PIC/s GMP as the standard on the manufacture of pharmaceutical products

AO 2012-008

FDA mandated all drug manufacturer to ensure strict and full compliance to the newly adopted PIC/s GMP

MC 2012-004

International Organization for Standardization

N/A

International Council for Harmonization of Technical Requirements for pharmaceuticals for Human use

N/A

Q1-Q7

Basic Quality guidelines

Q8-Q11

New Quality Paradigm/ Enhanced approach

Q12

New ICH Quality Topic

International Standards:

International Organization for Standardization International Council for Harmonization Pharmaceutical Inspection Co-operation Scheme World Health Organization (WHO)

specialized agency of the United Nations that is concerned with International Public Health

World Health Organization (WHO)

Local Standards:

ASEAN Phil FDA

Purpose: ➢ to accelerate the economic growth, social progress and cultural development ➢ To promote regional peace and stability through abiding respect for justice and the rule of law in the relationship among countries

ASEAN – Association of Southeast Asian Nation

responsible for the enforcement of quality requirement including GMP standards ➢ To ensure that the regulated pharmaceutical products on the market meet efficacy, safety, and purity requirements.

Phil FDA – Food and Drug Administration

-you are following the required standards applicable to your industry. -is less costly to implement and maintain. - is the minimum standard applicable to your industry.

GMP

-you go a few more steps ahead to ensure that you comply with the latest regulations. -requires more investment in additional testing and state-of-the-art technologies, -you are compliant with the most current rules and regulations applicable to your industry.

cGMP

GMP yield Good Quality:

Management Commitment & Continual Improvement Personnel Training & Competency Product Control Risk Management Quality Management Systems Site & Facilities Management

KEY ELEMENTS OF GMP (5 P’s):

➢People ➢Premises ➢Processes ➢Products ➢Procedures

General Chapters of PIC/s GMP

➢Quality Management ➢Personnel ➢Premises and Equipment ➢Documentation ➢Production ➢Quality Control ➢Contract Manufacturer and Analysis ➢Complaints and Product Recall ➢Self-inspection