Intro Flashcards
• 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
• 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
Areas of Manufacturing:
- Manufacture of API and Excipients
- Manufacture of finished dosage form
- Packing, labeling, repacking of finished bulk
are bulk products that are pharmaceutically active and generate a desired pharmacological effect.
API
are pharmacologically non active substances that are
generally used as a carrier of the API in the drug.
Excipients
Types of Drug Establishments:
- Drug Manufacturer
- Drug Trader
- Drug Distributor
Any establishment engaged in operations involved in the production of drugs.
Drug Manufacturer
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
registered owner of the drug product but contracts toll manufacturers
Drug Trader
Agreement whereby a competent company processes a raw materials or semi-finished goods or package products for another company.
Toll Manufacturing
Import raw materials or finished products from other countries for distribution to drug outlets.
Drug Importer
Exports raw materials or finished products to be distributed to other countries.
Drug Exporter
Acquire raw materials or finished products from local establishment distributed on a wholesale basis.
Drug Wholesaler
TOP PHARMACEUTICAL INDUSTRY in The Philippines:
Boehringer Ingelheim
gsk
Abbott
Pfizer
Unilab
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
– RM and PM section
• Quarantined materials (yellow)
• Approved for use materials (green)
• Rejected materials (red)
– In-Process
– Finished Products/Goods
– Returned Goods
– Dispensing
WAREHOUSE
– Develops products to be marketed by the company
– Library, animal house, pilot plant
RESEARCH DEPARTMENT
– Manufacturing of drug products
PRODUCTION/MANUFACTURING DEPARTMENT
– 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
– 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
