Pharmaceutical Analysis & standards

Question 1

branch of chemistry, which involves the
series of process for the identification,
determination, quantitation, and purification

Answer 1

Pharmaceutical analysis

Question 2

ICH

Answer 2

International Council for harmonization of technical requirements for pharmaceuticals for Human use

Question 3

ICH Quality guidlenes

Answer 3

Q1A-Q1F Stability
Q2-Analytical Validation
Q3A-Q3D Impurities
Q4A-Q4B Pharmacopoeias
Q5A-Q5E Quality of Biotechnological Products
Q6-Specifications
Q7-Good Manufacturing Practice
Q8-Pharmaceutical Development
Q9-Quality Risk Management
Q10-Pharmaceutical Quality System
Q11-Development and Manufacture of Drug Substances
Q12-Lifecycle Management

Question 4

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

Answer 4

WHO – World health Organization

Question 5

PICS

Answer 5

Pharmaceutical Inspection Co-operation Scheme

Question 6

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

Answer 6

ASEAN – Association of Southeast Asian Nation

Question 7

certifies that businesses, government organizations and social entities meet certain common standards.
Purpose:
to make products and services better and to make companies, governments and other organizations more efficient.

Answer 7

ISO- International Organization for Standardiztion

Question 8

is a family of Quality Management
System (QMS) standards to ensure
organizations produce quality products and services. This family includes the ISO 9001 standard.

Answer 8

ISO 9000

Question 9

establishes requirements for an

Environmental Management System (EMS) that is based on continuous improvement.

Answer 9

ISO 14000

Question 10

is a family of standards for information

technology, with the aim of improving information security and protecting company assets.

Answer 10

ISO 27000

Question 11

is for implementing a food safety

management system.

Answer 11

ISO 22000

Question 12

is a newer standard released in 2011.
It is for companies requiring an Energy
Management System (EMS) for improving energy use and efficiency.

Answer 12

ISO 50001

Question 13

Purpose:
➢ 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.

Answer 13

Phil FDA – Food and Drug Administration