Classification of survival and assessment of compliance with good practice of drug preservation

Contents enclosed with Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health

Classification of survival levels

1. Serious existence: are deviations from GSP standards leading to drugs; drug ingredients that do not guarantee quality, safety, effectiveness and pose a serious risk to the health and life of users or the community; or is the combination of some heavy existence indicating a serious shortcoming of the system. It includes findings of fraud, forgery, data/data correction.

2. Severe existence: is not serious existence but may lead to the preservation of products and raw materials that do not comply with the manufacturer’s preservation instructions; or in connection with a major deviation from GSP regulations or storage conditions; or in connection with non-compliance with preservation procedures or the inability of a competent person to meet the requirements of responsibility at work; or a combination of other existences, none of which exist in that complex are considered to exist heavily, but when they appear together these existences will form a heavy existence and should be analyzed and reported as a heavy existence.

3. Mild existence: those that do not classify as serious or severe existence, but are a deviation from the GSP standard.

GSP compliance assessment

Level 1: The facility does not exist seriously and exists severely.

Level 2: The facility does not exist seriously and has severe existence.

Level 3: The facility exists seriously.

See level classification details in: Appendix V