Quality

Avant Fine Chemicals Ltd. is a chemical-pharmaceutical company that is exclusively dedicated to the production of synthetic Active Pharmaceutical Ingredients (APIs) in accordance with Current Good Manufacturing Practices (cGMP) to ensure that their products have reproducible quality and comply with pre-established specifications.

• Compliance with cGMP regulation issued by the Directorate General of Drug Administration of Bangladesh as well as other international organizations such as (in alphabetical order: US FDA, ICH, PIC/S, TGA and WHO or specific customer requirements.
• Regarding a pre-established specification we consider those in the Pharmacopeia (in alphabetical order): Bangladesh, BP, EP, USP, etc. and also those indicated by the ICH in connection with purity and residual solvents or those agreed with customers.
• Being updated and ensure to have all necessary materials for complying with regulations and procedures and to have the equipment’s, facilities and other means to ensure a working environment in accordance with cGMP and continuous improvement.
• Having a Quality Assurance unit that works independently from production unit.
• Ensuring a good organization where all units dealing with management, manufacturing and product control are fully participant and responsible for product quality.
• Perform and document the activities of the units according to standard operating procedures and instruction as described in the respective manuals: General Use, Research & Development, Pilot Plant, Quality Control, Occupational Safety and Health and Environmental.
• Keeping undated training plans to ensure continuous improvement.
• Quality Assurance unit releases products after a satisfactory evaluation of its manufacture and analysis.
• Customers and Regulatory Agencies are notified about any changes in manufacturing processes and specifications that may affect product quality.