Product development

Front

Good Clinical Practice (GCP) Guidelines

Back

1. 1. Malaysian Guidelines for GCP

2. 2. ICH E2A Clinical safety data management

3. 3. ICH E3 Clinical Study Reporting

Front

PRINCIPLES OF Good Clinical Practice (GCP)

Back

• Trials conducted according to ethical principles

• Benefits/ risk

• Rights/ safety and well-being of subjects

• Adequate information on product to support trial

• Data confidentiality

Front

Elements of GLP

Back

1. 1. Reagent/materials certification

2. 2. Documentation & its record

3. 3. Instrumentation validation

4. 4. Certification of laboratory facilities

5. 5. Quality Assurance

Front

Elements of GMP

Back

1. 1. production

2. 2. quality control

3. 3. PQS

4. 4. personnel

5. 5. documentation