Laboratory Management and Quality Assurance

Name: Mohammad Amir bin Mohammad Arshad
Subject Title: Laboratory Management and Quality Assurance
Topic: Organization or regulatory bodies that regulate the operations of clinical laboratories in Singapore

Singapore Good Clinical Practice Guidelines is launched by the Ministry of Health and the Asia Pacific Economic Co-operation (APEC) for GCP in Singapore in August 1998, together with Medicines (Clinical Trials) Amended Regulations 1998 regulates clinical trials.1 This allows APEC countries to form a regulatory framework in producing quality and efficient drug, attracting overseas companies to invest in Singapore.2

Principles
- Guarantees qualified investigators reporting information accurately.1
- Ensures safety and less risk to the trial subjects, by obtaining their consent.1
- Have sufficient data to support proposed trials.1
- Safe keeping of confidential records.1
- Follow closely to protocols.1

1. Conducting Clinical Trials in Singapore (1998). Retrieved June 16, 2008 from: http://www.sma.org.sg/smj/4004/articles/4004ra4.html

2. Active Promotion of Good Clinical Practice and Bio-Safety(2007). Retrieved June 16, 2008 from: http://www.biomed-singapore.com/bms/sg/en_uk/index/about_biomedical_sciences/regulatory_framework/research.html