What are regulations on developing regulations, procedures, recording and storing documents on drug mixing in Vietnam?
What are regulations on developing regulations, procedures, recording and storing documents on drug mixing in Vietnam? Thank you!
Pursuant to Article 7 of the Circular 30/2021/TT-BYT (takes effect from 01/03/2022) stipulating regulations on developing regulations, procedures, recording and storing documents on drug mixing in Vietnam as follows:
- Develop regulations and procedures for drug quality assurance
+ Medical establishments shall rely on regulations on drug quality management, labeling, biomedical waste, and good manufacturing practice for drugs of WHO to develop regulations on mixing drugs, regulations on drug quality assurance;
+ Regulations on mixing drugs must contain the following: mixing formula, standards and requirements of ingredients, mixing, packaging, inspecting, control procedures during mixing process, quality standards of finished products, labeling and preservation;
+ Drug mixing regulations and procedures, drug quality must be approved by councils for drugs and treatment of medical establishments (if any) and heads of the medical establishments.
- Quality standards for mixing drugs are mentioned under Clause 2 Article 2 hereof.
+ Medical establishments must apply quality standards (base standards or Vietnamese Pharmacopoeia or any of the reference pharmacopoeia) to all mixed drugs at the establishment;
+ Quality standards are developed to meet drug quality control requirements and approved by heads of medical establishments or permitted for application.
- Drug mixing dossiers
+ Drug mixing dossiers shall be produced on a case-by-case basis and contain the following primary contents: name of drugs, contents, concentration of products, date of mixing, formula, quantity of finished products, persons mixing drugs, and persons carrying out quality control;
+ Mixing dossiers must include time and countersignature of persons mixing drugs and persons carrying out quality control and shall be kept at workplace. Drug mixing dossiers must be kept for at least 1 year past the drugs’ expiry date.
Best regards!
