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Pharmaceutical Manufacturing > Intro > Flashcards

Intro Flashcards

1
Q

• 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

A

Pharmaceutical Manufacturing

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2
Q

• 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.

A

Pharmaceutical Manufacturing

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3
Q

Areas of Manufacturing:

A
  1. Manufacture of API and Excipients
  2. Manufacture of finished dosage form
  3. Packing, labeling, repacking of finished bulk
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4
Q

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

A

API

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5
Q

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

A

Excipients

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6
Q

Types of Drug Establishments:

A
  1. Drug Manufacturer
  2. Drug Trader
  3. Drug Distributor
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7
Q

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

A

Drug Manufacturer

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8
Q

Types of Drug Manufacturer

A

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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9
Q

registered owner of the drug product but contracts toll manufacturers

A

Drug Trader

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10
Q

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

A

Toll Manufacturing

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11
Q

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

A

Drug Importer

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12
Q

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

A

Drug Exporter

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13
Q

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

A

Drug Wholesaler

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14
Q

TOP PHARMACEUTICAL INDUSTRY in The Philippines:

A

Boehringer Ingelheim
gsk
Abbott
Pfizer
Unilab

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15
Q

DEPARTMENTS IN DRUG ESTABLISHMENTS:

A

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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16
Q

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

A

WAREHOUSE

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17
Q

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

A

RESEARCH DEPARTMENT

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18
Q

– Manufacturing of drug products

A

PRODUCTION/MANUFACTURING DEPARTMENT

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19
Q

– 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

A

QUALITY CONTROL DEPARTMENT

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20
Q

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

A

ENGINEERING DEPARTMENT

21
Q

– Purchasing department
– Inventory control
– Planning and scheduling

A

PRODUCTION CONTROL DIVISION

22
Q

– Physical and medical examination of employees and applicants

A

MEDICAL DEPARTMENT

23
Q

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

A

MARKETING DEPARTMENT

24
Q

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

A

ADMINISTRATION

25
Q

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

A

REGULATORY DEPARTMENT

26
Q

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

A

CURRENT GOOD MANUFACTURING PRACTICES
(cGMP)

27
Q

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

A

CURRENT GOOD MANUFACTURING PRACTICES
(cGMP)

28
Q

• 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.

A

CURRENT GOOD MANUFACTURING PRACTICES
(cGMP)

29
Q

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

A

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
Objective:

30
Q

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

A

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
Quality Control:

31
Q

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

A

CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
Quality Assurance:

32
Q

adaptation of the first edition of the cGMP
Guidelines by BFAD

A

AO 43 s. 1999

33
Q

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

A

AO 2012-008

34
Q

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

A

MC 2012-004

35
Q

International Organization for Standardization

A

N/A

36
Q

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

A

N/A

37
Q

Q1-Q7

A

Basic Quality guidelines

38
Q

Q8-Q11

A

New Quality Paradigm/ Enhanced approach

39
Q

Q12

A

New ICH Quality Topic

40
Q

International Standards:

A

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

41
Q

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

A

World Health Organization (WHO)

42
Q

Local Standards:

A

ASEAN
Phil FDA

43
Q

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

A

ASEAN – Association of Southeast Asian Nation

44
Q

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.

A

Phil FDA – Food and Drug Administration

45
Q

-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.

A

GMP

46
Q

-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.

A

cGMP

47
Q

GMP yield Good Quality:

A

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

48
Q

KEY ELEMENTS OF GMP (5 P’s):

A

➢People
➢Premises
➢Processes
➢Products
➢Procedures

49
Q

General Chapters of PIC/s GMP

A

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

Pharmaceutical Manufacturing (9 decks)

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