Toxic heavy metals and microbial contamination tests should be conducted using methods that are in accordance with the latest edition of one of the following pharmacopoeias: British Pharmacopoeia, Chinese Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, etc.
The requirement for testing of CPM to be conducted at laboratories with accredited testing methods has commenced in stages and CPM dealers are encouraged to send their products for testing at such laboratories.
Dealers with specific products that require testing at the laboratories accredited for testing of CPM have been informed by HSA accordingly. For new CPM product applications, the applicant will be informed prior to product approval whether the CPM requires testing at such laboratories.
HSA has compiled a list of laboratories accredited for testing of CPM in Singapore as well as a list of overseas laboratories for dealers' easy reference. Test reports from overseas laboratories accredited for testing of CPM would be acceptable for the following tests:
a) Toxic heavy metals
b) Microbial contamination
c) Other substances as may be required by HSA
List of laboratories accredited for testing of CPM in Singapore58 KB
List of overseas laboratories accredited for testing of CPM in Singapore182 KB
Please be reminded that the lists serve as a reference and may not necessarily be valid. In view that the types of tests and test methods that the laboratories are accredited to conduct may vary from time to time, dealers are advised to verify the accreditation status of the laboratories’ test methods when intending to engage their services. The onus of responsibility remains with the dealers to ensure that the laboratory they have engaged holds the necessary valid accreditation for the relevant test methods.
For the detailed description of the laboratories’ scope of accreditation, please visit the websites stated in the User Guide214 KB which HSA has prepared to help dealers navigate the websites.