View Measure
| Name | This measure imposes testing requirement for pharmaceutical products which include conditions on testers (inspector with appropriate analytical skills), venue for sampling and sampling equipment |
|---|---|
| Description | Stipulating condition for: 1. conditions on testers 2. venue for sampling 3. sampling equipment |
| Comments | 1. conditions on testers: The Tester must be an inspector or a specialized quality control inspector or a member of the inspection team set up by the agency in charge of State management and inspection of drug quality; have knowledge of drug analysis or testing, firmly grasp legal documents on drug quality management, legal procedures and sampling techniques; must be technically trained and regulated, and must wear appropriate protective clothing when sampling. 2. venue for sampling: This shall be done in a separate area meeting the hygienic requirements (clean grade) and technical requirements of each sample (temperature, humidity, light, ...), avoiding the risk of contamination, cross-contamination of the quality of samples taken as well as the remaining drug after sampling. For sterile materials, sampling should be carried out in a clean, sterile area 3. sampling equipment Samplers and sample containers must be made of inert materials appropriate to the characteristics of each type, ensuring that they do not affect the quality of the samples and do not put impurities into contaminated samples or cross contamination. for samples as well as to ensure the safety of samplers (Refer to Appendix 2) |
| Validity From | 27-02-2010 |
| Validity To | 31-12-9999 |
| Reference | |
| Technical Code | |
| Agency | Ministry of Health |
| Created Date | 2018-01-18 14:57:43 |
| Updated Date | 2018-01-18 15:04:40 |
| Status | Inactive |
| Measure Type | Inspection Requirement |
| Legal/Regulation | Circular 04/2010/ TT-BYT guiding drug sampling for quality assurance issued by the Ministry of Health |
| Un Code | B82 - Testing requirement |
Procedures
| Procedure Name | Description | Category | View Procedure Detail with Relevant Forms |
|---|---|---|---|
| No results found. | |||
This measure applies to commodity/s
Displaying 1-10 of 84 result(s).
| HS Code | Description |
|---|---|
| 30012000 | - Extracts of glands or other organs or of their secretions |
| 30019000 | - Other |
| 30021010 | - - Plasma protein solutions |
| 30021030 | - - Antisera and immunological products, whether or not modified or obtained by means of biotechnological processes |
| 30021040 | - - Haemoglobin powder |
| 30021090 | - - Other |
| 30022010 | - - Tetanus toxoid |
| 30022020 | - - Pertussis, measles, meningitis or polio vaccines |
| 30022090 | - - Other |
| 30023000 | - Vaccines for veterinary medicine |
Member Area
Search this Site
Contents
|
A Quick Intro |
Search Trade Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feature Information
|
|
|
|
|
|
|
|
|
|
|
.png){kind=small}
Information & Articles
|
|
|
|
|
|
|
|
|
|
|
.png){kind=small}
|
Contact Us! If you cannot find what you require in this website please feel free to contact us. Click here to send us a message >>>
|
Upcoming Events