What qualifications and specific quality standards are required for manufacturers of pharmaceutical-grade chlorhexidine acetate?

What qualifications and specific quality standards are required for manufacturers of pharmaceutical-grade chlorhexidine acetate?

Manufacturers of pharmaceutical-grade chlorhexidine acetate need to possess the following qualifications:

- Production license-related qualifications

- Business license: This is the basic certificate for legal operation, proving that the enterprise has legitimate market entity status and conducts production and operation activities within the registered business scope.

- Drug manufacturing license: The production of pharmaceutical-grade chlorhexidine acetate falls under the category of drug manufacturing. Enterprises must obtain the "Drug Manufacturing License" issued by the drug regulatory department, which specifies the permitted categories, dosage forms, production sites, and other licensing matters for drug production.

- Hygiene license for disinfectant product manufacturers: Chlorhexidine acetate is also commonly used in disinfectant products. Manufacturers must obtain the "Hygiene License for Disinfectant Product Manufacturers" issued by the provincial health administrative department of their location to prove compliance with hygiene requirements for disinfectant production.

- Quality management-related qualifications

- Drug GMP certificate: Good Manufacturing Practice (GMP) for drugs is the basic guideline for drug production and quality management. GMP certification indicates that the enterprise meets GMP requirements in personnel, facilities, equipment, materials, production management, and quality management, ensuring drug quality and safety.

- Quality management system certification: Such as ISO9001 quality management system certification. Although not mandatory, it helps enterprises establish a comprehensive quality management system and improve management levels and product quality stability.

- Other relevant qualifications

- Environmental protection permit: The production process may generate pollutants such as wastewater, exhaust gas, and waste residue. Enterprises need to obtain an environmental protection permit to ensure that their environmental protection facilities comply with national and local environmental requirements and that pollutant emissions meet standards.

- Work safety permit: The production of pharmaceutical-grade chlorhexidine acetate involves processes such as chemical synthesis, which carries certain safety risks. Enterprises need to obtain a work safety permit to demonstrate that they have the conditions for safe production and can ensure safety during the production process.

In addition, relevant personnel of the enterprise, such as the enterprise responsible person, quality responsible person, and production management personnel, need to possess corresponding professional knowledge and qualifications, such as backgrounds in pharmacy, medicine, or related fields, and undergo appropriate training and assessment. At the same time, the enterprise must also register or file the product in accordance with relevant regulations, such as conducting health safety evaluation and filing for disinfectant products.

What qualifications and specific quality standards are required for manufacturers of pharmaceutical-grade chlorhexidine acetate?

What are the specific quality standards for pharmaceutical-grade chlorhexidine acetate?

The quality standards for pharmaceutical-grade chlorhexidine acetate are mainly based on the Chinese Pharmacopoeia and other relevant regulations. The specific content is as follows:

1. Description: A white or almost white crystalline powder; odorless. Soluble in ethanol, slightly soluble in water.

2. Identification:

- Take an appropriate amount of the product, add ethanol to prepare a solution containing 10 μg per 1 ml. Determine by ultraviolet-visible spectrophotometry, and there should be maximum absorption at a wavelength of 259 nm.

- The aqueous solution of the product shows the identification reaction of acetate.

3. Related substances: Test by thin-layer chromatography. Use a specific thin-layer plate (take 8g of silica gel GF254, add 22ml of sodium formate solution (1→22), and coat to prepare the plate). If impurity spots appear in the test solution, they should not be deeper than the main spot of the reference solution (1). If one impurity spot exceeds, it should not be deeper than the main spot of the reference solution (2).

4. Loss on drying: Dry the product at 105°C to constant weight. The weight loss should not exceed 3.5%.

5. Residue on ignition: Should not exceed 0.1%.

6. Assay: Calculated on the dried basis, the content of C₂₂H₃₀Cl₂N₁₀·2C₂H₄O₂ should not be less than 97.5%.