cgmp

Question 1

Poor quality medicines do not meet official standards for:

Answer 1

STRENGTH
QUALITY
PURITY
PACKAGING
LABELING

Question 2

• First WHO draft text on good manufacturing practices requested by the Twentieth World Health Assembly (resolution WHA20.34)

• Twenty-first World Health Assembly

• “Draft requirements for good manufacturing practice in the manufacture and
quality control of drugs and pharmaceutical specialties”

Answer 2

1967

Question 3

• WHO Certification Scheme on the Quality of Pharmaceutical (GMP text as an integral part of the Scheme

Answer 3

1969

Question 4

• revised versions of both the Certification Scheme and the GMP text

Answer 4

1975

Question 5

includes the following:
• starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting and importing member country

• veterinary products administered to food-producing animals;

• information on safety and efficacy

Answer 5

Certification Scheme

Question 6

Presented in 1992

• Quality management in the drug industry: philosophy and essential elements”, outlines the general concepts of quality assurance as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management.

Answer 6

Revised Requirements for GMP

Question 7

Revised Requirement for GMP includes

Answer 7

• hygiene
• validation
• self-inspection
• Personnel
• premises,
• equipment,
• materials and documentation.

Question 8

Part of QA aimed at ensuring that PRODUCTS are consistently MANUFACTURED and CONTROLLED to the quality standards appropriate to their intended use (WHO, 2007)

Answer 8

GMP/ cGMP

Question 9

Part of cGMP is concerned with

Answer 9

• sampling
• specifications and testing
• documentation and release procedures
• aims at diminishing the risks inherent in any pharmaceutical production
• cross contamination/mixed ups
• false labeling
• manufacturing firm should not place the patient at risk due to: inadequate safety, quality or efficacy

Question 10

Philippine GMP Regulations

Answer 10

AO 43 s. 1999
AO 2012-2008
FDA MC 2012-004

Question 11

AO 43 S. 1999

Answer 11

Adoption of the 1st edition of the Current Good Manufacturing Practice Guidelines by the Bureau of Food and Drugs

Question 12

AO 2012-2008

Answer 12

Adoption and Implementation of the GMP as the standard on the manufacture of pharmaceutical products

Question 13

FDA MC 2012-004

Answer 13

Philippine FDA mandated all drug manufacturers to ensure strict and full compliance to the newly adopted GMP

Question 14

Current Good Manufacturing Practices in the following areas:

Answer 14

• Building and Premises
• Equipment
• Personnel
• Components
• Master Formula and Batch Production Record
• Production and Control Procedures
• Laboratory Controls
• Product Containers
• Packaging and labeling
• Finished Goods- Warehouse Distribution Control Records
• Stability
• Complaint File

Question 15

First WHO draft text on good manufacturing practices requested by the:

Answer 15

Twentieth World Health Assembly (resolution WHA20.34)