PRELIM 03 - Pharmaceutical Standards

Question 1

Is an independent, non-governmental organization that develops and publishes many international standards

Answer 1

International Organization for Standardization (ISO)

Question 2

Emphasizes the establishment and maintenance of a robust QMS for pharmaceutical companies (ISO standards)

Answer 2

ISO 9001:2015 (Quality management systems requirements)

Question 3

Often incorporates GMP practices specifically for primary packaging materials for medicinal products (ISO standards)

Answer 3

ISO 15378:2017 (Primary packaging materials for medicinal products)

Question 4

Is the internationally recognized standard for QMS in the design and manufacture of medical devices (ISO standards)

Answer 4

ISO 13485:2016

Question 5

Organization that acts as the directing and coordinating authority on international health work

Answer 5

World Health Organization (WHO)

Question 6

According to WHO, __________ form the foundation for all pharmaceutical quality assurance

Answer 6

Good manufacturing practices (GMP)

Question 7

Is a collection of recommended procedures published by WHO that contains analysis and specifications for active pharmaceutical ingredients, excipients, and finished pharmaceutical products

Answer 7

International pharmacopoeia

Question 8

Their mission is to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration

Answer 8

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Question 9

A framework established by ASEAN nations in the form of a unified regulatory system ensuring quality, safety, and efficacy of pharmaceuticals

Answer 9

ASEAN pharmaceutical regulatory framework (APRF)

Question 10

Its objective is to “improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods”

Answer 10

United States pharmacopoeia (USP)

Question 11

Are official documents that provide detailed specifications for drugs, including its identity, strength, purity, and performance

Answer 11

USP monographs

Question 12

Agency that plays an important role in the quality, safety, and efficacy of pharmaceutical goods

Answer 12

Food and Drug Administration (FDA)

Question 13

Organization that aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors

Answer 13

Pharmaceutical Inspection Cooperation Scheme (PIC/S)