Regulations on Drug and Pharmaceutical Ingredient Quality

Regulations on Drug and Pharmaceutical Ingredient Quality

1. Quality Standards for Drugs and Pharmaceutical Ingredients

Quality standards for drugs and pharmaceutical ingredients include:

• Quality indicators: Factors that are tested to assess the quality of the drug, for example: properties, clarity, volume, sterility, particulate limit, qualitative, quantitative.

• Quality levels: Acceptable limits for each quality indicator.

• Testing methods: Methods used to test and evaluate the quality of drugs, ensuring that they meet quality standards.

2. Other Requirements Related to Drug Quality

In addition to drug quality, other factors also affect the overall quality of the drug, including:

• Packaging: Ensuring proper drug storage and protection from external environmental influences.

• Labeling: Providing complete information about the drug, such as the drug name, ingredients, dosage, usage instructions, expiration date, etc.

• Storage: Adhering to appropriate storage conditions to ensure drug quality.

• Transportation: Transporting drugs safely and according to regulations to avoid affecting quality.

3. Quality Levels

Quality levels are specified for each quality indicator and are acceptable limits. For example:

• Permitted deviation limit in volume for liquid drugs: + 10%

• Permitted limit for drug concentration and content: +-

• Most important quality indicators in eye drops: Sterility and particulate limit

4. Quality Standards

• National and establishment standards: Establishment standards are usually higher than national standards.

• Vietnamese Pharmacopoeia: Compiled by the Vietnamese Pharmacopoeia Council and issued by the Minister of Health.

5. Sample Retention Time

• Drug testing establishments:

• After the drug’s expiration date: 12 months

• Samples of drugs taken for quality testing: 24 months from the date of sampling

• Manufacturing and importing establishments:

• Finished drug expiration date: 12 months

• Ingredients after the expiration date of the finished product produced from that active substance: 12 months

6. Record Retention Time

• Drugs or ingredients: At least 2 years after the expiration date of the drug

7. Drug Violation Levels

• Level I: Risk of serious harm to health or impact on the life of the user.

• Level II: Drugs do not fully ensure treatment effectiveness or have a risk of being unsafe for users, but not to the extent of causing serious harm to health or affecting the life of the user.

• Level III: Not covered under Level I and II, due to other reasons but does not affect treatment effectiveness and safety when used.

8. Examples of Violation Levels:

• Drugs produced from substandard ingredients: Level II

• Drugs with registration certificates issued based on falsified documents according to the conclusion of the competent authority: Level II

• Liquid injectable drugs with a volume less than 75% of the volume on the label: Level II

• Powder packs with a drug mass less than 75% of the mass on the label: Level II

• Tablets with an average dissolution rate less than 50% of the quality level specified in the quality standard: Level II

• Drugs failing quality standards for related impurities: Level II

• Drugs failing quality standards for pH: Level II

• Counterfeit drugs, smuggled drugs, drugs of unknown origin: Level I

• Drugs failing visual inspection standards: Level III

• Starch tablets with a mass greater than 75% of the label but less than the registered quality standard limit: Level III

• Gastric release tablets failing quality standards for disintegration time but the increase in time is less than 2 hours: Level III

• Creams and ointments failing quality standards for the indicator of mass: Level III

• Tablets failing quality standards for mass deviation: Level III

• Drugs failing quality standards for density: Level III

9. Handling of Recalled Drugs at Level I or II: Destruction

Note: This is general information about regulations on drug and pharmaceutical ingredient quality. Specific application will depend on the type of drug, the specific case, and current legal regulations.