ABOUT

Responsibilities of sections

1. Chemical and Physical Testing Section

Chemical and Physical Testing Section is divided into four laboratories: Chemical and Physical Testing Laboratory 1, 2, 3 and 4. Their responsibilities are as follows:

• perform both physical and chemical analysis of pharmaceutical products
• testing of imported active pharmaceutical ingredients (API) to ensure their compliance with established specification
• conduct research programme to develop new testing methods
• develop and transfer analytical technology to government and private laboratories
• develop test kit for screening test of drug substances and adulterations
• qualitative analysis of seized materials

2. Narcotic Section

Narcotic Section consists of three laboratories: Narcotic Laboratory 1, 2 and 3. Their responsibilities are as follows:

2.1 Narcotic Laboratory 1

• confirmatory test of narcotics in urine specimens
• develop standard test methods
• develop test kit for screening test of psychotropic and narcotic substances
• conduct survey for drug abuse

2.2 Narcotic Laboratory 2

• qualitative and quantitative analysis of illicit drugs
• develop standard test methods
• develop test kit for screening test of psychotropic and narcotic substances
• conduct survey for drug abuse.

2.3 Narcotic Laboratory 3

• chemical analysis for psychotropic and narcotic substances used as medicines
• qualitative and quantitative analysis of illicit drugs
• develop standard test methods
• develop test kit for screening test of psychotropic and narcotic substances
• conduct survey for drug abuse.

3. Biological Testing Section 

Biological Testing Section consists of three laboratories: Biological Testing Laboratory 1, 2 and 3. Their responsibilities are as follows:

3.1 Biological Testing Laboratory 1

• analysis of antibiotics using microbiological methods
• contamination testing of analysis of non-sterile pharmaceutical products
• sterility testing of parenteral products
• conduct research programme to develop new testing methods
• develop and transfer analytical technology to government and private laboratories

3.2 Biological Testing Laboratory 2

• research and development on biopharmaceutical products
• development of standard method for quality control of biopharmaceutical products including biosimilars
• post-marketing surveillance of biopharmaceutical products including biosimilars
• provide technical support and training to government and private sectors

3.3  Biological Testing Laboratory 3

• pyrogen / bacterial endotoxin testing of parenteral products
• biocompatibility testing of plastics and polymers
• conduct research programme to develop new testing methods
• develop and transfer analytical technology to government and private laboratories

4.  Quality and Technical Development Section

• prepare strategic plan, action plan, budget, personnel development, coordinate and organizes local as well as international training programmes
• coordinate quality assurance activities to ensure that all laboratory activities are performed according to laboratory quality system
• planning for instrument calibration according to quality system
• IT programme developing for the Bureau
• coordinate the proficiency testing programme to assess laboratory performance

5. Thai Pharmacopoeia Section

• study on various aspects of drugs and preparations e.g. their pharmacology, chemistry, including testing the methods for identification and assays in order to establish their specifications in the Thai Pharmacopoeia
• publish the successive volume of Thai Herbal Pharmacopoeia
• issue the Pharmacopoeial Newsletter

6. Reference Standard Center

• establish drug and narcotic reference substances for locally use and within ASEAN member countries
• training center for the production of ASEAN reference substances for member countries

7. Administrative Office

• receive and dispatch official papers
• type analytical reports and official correspondence
• filing and archiving documents
• procurement of laboratory, scientific as well as office supplies
• maintain accounting, administrative budget management and personnel services
• serve as central registry for incoming sample