Manuf lec 4 yata hehe IJNIP

Good manufacturing practice

The procedure employed to ensure the drug products or substances is manufactured under quality management system.

1960

GMP was first used in USA federal legislation

1967

WHO issued its first guidelines on GMP

1989

Revised regulation for the licensing of drug establishment and outlets.

Administrative order no. 56s 1989

What was established on 1989?

1989

BFAD special audit group was formed

Bureau of Food and Drugs

What is the meaning of BFAD

AO NO. 43 s 1999

1999

Amendment of AO NO. 220 s 1974 into Current good manufacturing practice for drugs

What states in AO no. 43s 1999?

QA system

Should be fully documented & its effectiveness should be monitored.

Quality assurance

Covers all matter influence the quality of a product

Quality assurance

Refers to a sum of total activities organized with an aim to ensure the products are of the require quality.

Good manufacturing practice

Prt of QA which ensures that products produced are consistently produced and controlled to the quality standard appropriate to their intended use.

Cross contamination

Mix up

What are the minimal risk in GMP?

Quality control

Concerned with sampling, specification and testing

Quality control

Ensure that the materials or products will be released for sale or supply until their quality have been evaluated.

Starting material

Packaging material

Intermediates and finished product

Bulk products

Environmental conditions

Scope of quality control concerned

Quality management

Quality assurance

Good manufacturing practice

Quality control

Quality relationship

Drugs: Current Good manufacturing practice in manufacture, processing, packing, or holding.

What does AO no 220s 1974 about?