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This application is a service of the Singapore Government.

Health Sciences Authority

Requirements of Test Reports 检验报告的要求

1. Parameters to be Tested and Their Limits 检测要求的项目及检测结果的限定范围
 

Toxic heavy metals limits for CPM are as follows (有毒重金属的限量标准):

 Heavy Metal
重金属
Permissible limits
限量

Arsenic  砷

5 ppm

Copper  铜

150 ppm

Lead  铅

20 ppm

Mercury  汞

0.5 ppm

Microbial limits for CPM are as follows (微生物的限量标准):

For oral CPM
中成药(口服)
Microbial limits 
限量

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 10CFU

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

Escherichia coli 大肠埃希氏杆菌
Salmonellae 沙门氏菌族
Staphyloccocus aureus 金黄色葡萄球菌

Absent in 1g or ml

每一克或一毫升的药品不能含有

For topical CPM
中成药(外用)
Microbial limits 
限量

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 10CFU

Yeast and mould count

酵母及霉菌

Not more than 5 X 10CFU per g or ml

每一克或一毫升不超过 5 X 102 CFU

Pseudomonas aeruginosa 绿脓假单胞菌
Staphyloccocus aureus 金黄色葡萄球菌

Absent in 1g or ml

每一克或一毫升的药品不能含有

2. Requirements on Testing Methodology 检测方法的要求

Toxic heavy metals and microbial contamination tests should be conducted using methods that are in accordance with the latest edition of the following pharmacopoeias: British Pharmacopoeia, Chinese Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, etc.

产品重金属及微生物的检测方法,应依据最新版本药典(包括英国药典,中国药典,欧洲药典,美国药典等)的要求。

3. Requirements on Test Reports 检验报告的要求

a. The tests must be conducted on finished products. Tests done on intermediate products or raw materials would not be acceptable.

检测的产品必须是成品,任何原料或半成品的检验报告将不被接受。

b. The product's batch number must be stated on the test report, and it must be in accordance with the batch numbering system declared in the online application form. A written explanation should be submitted for any deviation from the declared batch numbering system. The same batch number should be tested and reflected on both test reports if the tests on toxic heavy metals and microbial limits were done separately.  

检验报告必须注明产品的生产批号,此批号要求与电子呈报系统中要求声明的“批号排列系统”相一致,如不一致,必须提交合理的解释。如果重金属与微生物是分别检测的,检验报告的批号必须相同(要求检测同批产品)。

c. The product's full product name must be stated on the test report:

检验报告中的产品名称要求与所呈交的申请相符:

Type of CPM
中成药申请类型
Acceptable Product Name on Test Report
检验报告所要的产品名称

Imported products

进口产品

Either the product name in the country of origin or the one intended for local sale

可以原产国或本地销售时的名称

Locally manufactured products

本地生产的产品

Product name stated in online application form

与申请的产品名称相同

Locally assembled products

(Primary assembly)

本地分装的产品(一级分装)

Product name of CPM after assembly

与分装后的产品名称相同

Locally assembled products

(Secondary assembly)

本地分装的产品(二级分装)

Either the product name of CPM before or after assembly

可为分装前或分装后的产品名称

d. The date of analysis stated on the test report must be within 2 years from the date of evaluation of the CPM product listing.

检验报告日期必须为二年之内(产品批准日期之前的二年内)。

e. If the test result is “not detected/ND”, the limit of detection must be stated on the test report.

如果检测结果为未检出, 必须在检验报告上注明检测仪器的最低检出量。

f. The test result cannot be stated as “less than legal limit” (e.g. “Copper < 150 ppm”).  A product with a test result that is too close to the legal limit is likely to fail re-testing conducted by different laboratories or using equipment.

检验结果不允许标识为“< 限定标准”,如“铜 < 150 ppm”。因为如果检测结果太接近于限定要求,经不同的检测机构或仪器再检验时,可能产品会超出所要求的限量,而导致产品不合格。

g. Test reports for CPM containing herbs with specific naturally occurring poisons controlled under the Poisons Act of Singapore have to be tested at laboratories with accredited testing methods , and the test results must be quantified in the test reports to be within the stipulated limits:

因中药麻黄、红曲米、硼砂、半边莲、制附子中含有被列入新加坡毒药法令中的成分,含有此类成分的中成药,要求提交由认证的实验室出具的,对以下成分的定量检测报告:

Substances
检测成分
Acceptable Limit
限量要求

Ephedra alkaloids 麻黄碱

< 1%

Lovastatin 洛伐他汀

< 1%

Sodium borate 硼酸钠

< 5%

Lobelia alkaloids 半边莲碱

< 0.1%

Aconite alkaloids 乌头碱

Dosing of < 60 mcg/day

每日用量不超过 60 微克

h. Every batch of CPM containing herbs with naturally occurring poisons (as described in point g. above), as well as those considered as high-risk (e.g. those with slimming claims) has to be tested at laboratories with accredited testing methods for the contents of toxic heavy metals and microbial contamination. 

如果产品含有麻黄、红曲米、硼砂、半边莲、制附子,或为高风险(如减肥等)而被要求每批都必须进行检测的中成药产品,其有毒重金属及卫生学的检验报告必须由认证的实验室出具。

Download.IconPdfSample of Test Report 检验报告实例
File Size: (334 Kb)

4. Accredited Laboratories 认证实验室

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

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 mothods.

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.

中成药由检验方法经认证的实验室进行的要求已分阶段实施,建议中成药经销商将其产品送交这类实验室进行检验。

卫生科学局已发信通知中成药经销商其经营的哪些产品要求送交认证检验中成药的实验室进行检验。新申请的中成药产品,如须送交此类实验室检验,卫生科学局会在产品批准前将具体要求通知申请者。

卫生科学局已收集本地认证实验室海外认证实验室中成药的实验室名单供经销商参考。海外认证检验中成药的实验室出具的以下检验报告也将被接受:

    a)    有毒重金属

    b)    卫生学检验

    c)    其它要求检测的成分

然而,由于实验室的认证状况以及受认可的检测项目及检验方法可能会随时间更改,建议中成药经销商在将产品交由某实验室检测前,先对该实验室相关的检验方法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。

有关认证实验室检测项目的详细信息,请访问查询指南中所列网站并参照指南中提供的步骤进行查询。

Updated-Jul15