Toxic heavy metals limits for CPM products are as follows (有毒重金属的检验):
Permissible limits 限制 | |
Arsenic 砷 | 5 ppm |
Copper 铜 | 150 ppm |
Lead 铅 | 20 ppm |
Mercury 汞 | 0.5 ppm |
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Microbial limits for CPM products are as follows (卫生学检验):
For oral CPM 中成药(口服) | Microbial limits 限制 |
Total aerobic microbial count * 需氧微生物的总数* | Not more than 105 CFU per g or ml 每一克或一毫升不超过105 CFU |
Yeast and mould count * 酵母及霉菌* | Not more than 5 X 102 CFU per g or ml 每一克或一毫升不超过5 X 102 CFU |
Absent in 1g or ml: 每一克或一毫升的药品不能有任何: | Escherichia coli 大肠埃希氏杆菌 Salmonellae 沙门氏菌族 Staphyloccocus aureus 金黄色葡萄球菌 |
For topical CPM 中成药(外用) | Microbial limits 限制 |
Total aerobic microbial count * 需氧微生物的总数* | Not more than 104 CFU per g or ml 每一克或一毫升不超过104 CFU |
Yeast and mould count * 酵母及霉菌* | Not more than 5 X 102 CFU per g or ml 每一克或一毫升不超过5 X 102 CFU |
Absent in 1g or ml: 每一克或一毫升的药品不能有任何: | Pseudomonas aeruginosa 绿脓假单胞菌 Staphyloccocus aureus 金黄色葡萄球菌 |
* These limits do not apply to CPM derived from fermentation processes
* 经过发酵过程制成的中成药不受此限制
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Accredited Laboratories (认证实验室):
The requirement for testing of CPM to be conducted at accredited laboratories has commenced in stages since 1 Jan 2004.
Dealers with specific CPM that require testing at the accredited laboratories 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 accredited laboratories.
Other CPM dealers are also encouraged to send their products for testing at the accredited laboratories.
HSA has compiled a list of accredited laboratories in Singapore as well as a list of overseas accredited laboratories for dealers' easy reference. Test reports from overseas accredited laboratories would be acceptable for the following tests:
a) Toxic heavy metals
b) Microbial contamination
In view that the accreditation status of the laboratories as well as the types of tests that the laboratories are accredited to conduct may vary from time to time, dealers are advised to verify the accreditation status of the laboratories 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 detailed description of the laboratories scope of accreditation, please visit the websites stated in the User Guide which HSA has prepared to help dealers navigate the websites.
从2004年1月1日起，中成药由认证实验室检验的要求将分阶段实施。
卫生科学局已发信通知中成药经销商其经营的哪些中成药产品要求送交认证实验室检验。新申请的中成药产品，如须送交认证实验室检验，卫生科学局会在产品批准前将具体要求通知申请者。
其他中成药经销商也鼓励将产品送交认证实验室检验。
a) 有毒重金属
b) 卫生学检验
上查看本地及海外认证实验室名单。然而，由于实验室的认证状况以及受认可的检测项目可能会随时间更改，建议中成药经销商在将产品交由某实验室检测前，先对该实验室的认证状况进行确认。中成药经销商对确定实验室持有有效认证负有责任。
Updated-Mar 12
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