Quality Management System
The QMS of Maxfair & Company Limited is established in a frame to describe its operations in different documents and practices which is based on the principles of WHO guidelines.
The Quality Manual describes the Quality Policy of Maxfair & Company Limited. The responsibilities for the technical aspects of Quality Assurance are defined in the Quality Manual. It encompasses all activities necessary to generate, maintain and verify the quality of drugs.
The Quality Assurance of Savar Plant consists of Quality Control, Quality Compliance and Quality Surveillance. The main tasks and duties of Quality Control have been described in the Quality Manual and relevant SOPs. The Head of Quality Assurance or her delegates are responsible for releasing drug substances, excipients, dosage forms and packaging materials.
Quality Compliance is responsible for IPC, GMP co-ordination and training. Performances of routine GMP checks are done as per need. Monitors to respect GMP regulation in the manufacturing by instant checks of Batch Record completion, visual checks of cleaning of working place, line clearance, performance checks of balance & other equipment.
Quality Surveillance is responsible for the implementation of the Quality Management System in different areas in collaboration with different departments. Quality Surveillance play active role in conducting external and internal audits with their follow-ups.
Research & Development is responsible for formulation of new products and method development, implementing technology transfer to Production and Quality Control, and also covers process validation, cleaning validation, method validation and follow up stability.
The Quality Manual describes how testing instructions are established and used. The testing instructions include the specifications and testing methods. The testing instructions are binding for release testing and for follow-up stability testing.
Identification of Herbs & standard & control of other raw materials are followed with reference to approved pharmacopoeia.
A routine inspection is being done in the name of "Self Inspection" mainly concerned with safety, sanitation and infra-structural facilities leading to GMP including documentation.
Supplies of raw materials are mainly obtained from approved suppliers. We select and evaluate the supplier as per procedures. This procedure is also applicable in case of supply of Primary and Secondary Packaging Materials.