Our Quality System integrates all the current GMP (Good Manufacturing Practice) elements. Our premises, our equipment and our processes are all designed to meet the most stringent requirements applicable to primary packaging (solid dosages).
Processes and Methods
Our objective of full compliance without compromise is achieved through systematically reviewing and validating our practices, processes and methods on an on-going basis. The company’s validation master plan details the validation program as it applies to systems, processes and equipment related to packaging and warehousing operations. Operations are systematically controlled using change control procedures and documented deviations. The high quality and security standards established by GMP’s are also maintained through appropriate investigation procedures and effective treatment of complaints.
Personnel and Training
An on-going training program (GMP and technical training) for all employees involved in Production and Quality Control guarantees the competence and efficiency of our staff. Our Quality Control team is directly involved at every stage of operations, from the receipt of manufacturing components to the shipment of finished products.
Premises and Equipment
Packaging operations are conducted in separate rooms to avoid cross-contamination. Temperature is controlled throughout the plant, from the warehousing facilities to the production area. Relative humidity can be controlled, as required. For primary packaging, there are separate air treatment systems in each room to avoid cross-contamination. Equipment and utility systems (HVAC, compressed air) are qualified and under a proven preventive maintenance program. Access to the plant is controlled and a proven security system is in place. Access to the warehousing area is also controlled.