AMTECH strives to achieve quality of the products and services. Its quality assurance department ensures that quality; safety and efficacy are designed and built into our products. QAD is fully self reliant department with qualified, dedicated and experienced pharmacists to ensure that all the functions of Quality Control Department (QCD), Production Department, Store and House Keeping are well controlled.
o Set up procedures for implementation of WHO GMP o Evaluating and approval of all validation protocols. o Audit and approval of vendors. o Evaluating analyzing market complaints and batch Recall. o Routine finished product stability. o Assure regulatory and company standards. o Release or Rejects Raw materials, packing materials and finished products. o Supervise change control system. o Perform self inspection and GMP training. o Evaluation and approval of all final SOPS. o Review and approval of all master Processing procedures, master packing procedures and master analytical procedures. o Review and approval of all Batch processing Record prior to release of goods for distribution to ensure compliance to GMP during manufacturing of any batch. o Approval of final product specification.
Significant steps have been taken to assure the quality of products. These steps include advanced training of personnel, procurement of state of the art inspecting and analytical equipments and modernization of the quality control area. Department is independent of all other departments. The Quality Control Department controls all Raw materials, Bulk Product, intermediate product, finished Product, stability, Packing material, water and microbiology. QCD has been designed to suit the operations to be carried out in them. The environmental condition of the laboratory is maintained to meet the analytical requirements. QC department is well equipped with many of the advance instruments.
1. Microbiology Laboratory 2. Chemical Laboratory & 3. Instrumental Laboratory Our technical staff comprises of well-trained and experienced chemists to ensure the quality of the products in conformity with the quality standards. They are familiar with GMP/GLP & ISO. Quality Control Department is fully aware of the fact that quality is always the first and truly is motivated by its quality policy:
The priority of the department is to ensure the quality of the product manufactured at Amtech Med (P) Ltd for better Healthcare of the Nation.
Manufacturing is carried out as per national and international drug rules and regulations using technologically advanced machines and equipments.