Chapter IV
INSPECTORATE CONDUCTING INSPECTION OF COMPLIANCE WITH GACP FOR HERBAL MATERIALS AND PRINCIPLES AND STANDARDS FOR COLLECTING NATURAL HERBAL MATERIALS
Article 18. Composition and standards to be satisfied by members of an inspectorate
1. An inspectorate consists of:
a) the chief and the secretary affiliated to the receiving authority;
b) at least 01 member: the representative of the National Institute of Medicinal Materials;
c) 01 member: the representative of the Department of Health of a province or central-affiliated city (hereinafter referred to as “Department of Health”) where the herbal material cultivation, collection, processing and storage area is available;
d) at least 01 member: affiliated to the receiving authority;
e) other members at the request of the chief of the inspectorate.
2. A member of the inspectorate must satisfy the following standards:
a) He/She must obtain at least a bachelor’s degree and has been trained in pharmacy or agriculture, plant protection, agronomy, herbal material quality control and pharmaceutical management;
b) He/She has been trained in GACP, GACP inspection, and has a thorough grasp of GACP principles and standards;
c) He/She must be honest, objective and stringently compliant with the regulations of law during the inspection process and must not create any conflict of interest with the inspected facility as specified in Clause 3 of this Article;
d) The chief of the inspectorate must have at least 02 (two) years of experience in pharmaceutical or traditional medicine management.
3. Principles of assessment of conflict of interest: A member of the inspectorate shall be considered to have a conflict of interest with the inspected facility in any of the following cases:
a) He/She used to work or participate in providing consulting services for the inspected facility in the last 05 years;
b) He/She is receiving financial benefits from the inspected facility;
c) His/Her spouse, child, parent, biological sibling, father or mother-in-law is working for the inspected facility.
Article 19. Responsibilities and powers of inspectorate
1. The inspectorate has the responsibilities to:
a) assess the whole operation of the facility according to GACP principles and standards respectively specified in Article 5 of this Circular, updated versions of GACP principles and standards and relevant regulations; clearly record inspection contents and deficiencies found, prepare GACP inspection records and reports;
b) report the inspection results or provide an explanation to the GACP inspection report provided the facility has any disagreements with the report;
c) maintain confidentiality of all information relating to the inspection contents and the herbal material cultivation, collection, quality control, storage and distribution unless otherwise agreed upon by the facility or requested by the competent authority.
2. The inspectorate has the power to:
a) examine all of the areas related to herbal material cultivation, collection, processing and storage owned by the inspected facility;
b) request the facility to provide relevant documents;
c) collect documents, evidence (by copying documents, taking photos or recording videos) of deficiencies found during the inspection process;
d) collect samples of herbal materials to test for their quality as per law;
dd) make records, request the facility to suspend totally or partially its operations related to the violations; if the inspectorate finds that the facility commits a violation which severely affects the quality of the herbal materials during the inspection process it is required to notify the competent person thereof.
Tìm kiếm
Thông tư 19/2019/TT-BYT (Bản Word)
Thông tư 19/2019/TT-BYT (Bản Pdf)
