All products manufactured by the “Lumier Pharma” LLC are marked for efficiency and safety, and supported by original medicaments due, which is ensured by production compliance with established Quality Control System requirements.
Two cold storage chambers POLAIR KXK with temperature mode from +2 to +8 0С. Before entry into operation, these chambers were subjected to Installation Qualification, Operational Qualification and Production Qualification. The chambers feature the “DIXELL” automatic temperature monitoring system, and are equipped with emergency alarm system;
Proper qualification of personnel is maintained with use of continuous training system as per Enterprise Standard STP-10 “Training of Personnel” under the categories of: GMP requirements, personal hygiene requirements, qualification enhancement and professional training.
The Company’s Quality Control System encompasses all spheres of activity affecting the quality of final products. Handling of medicaments requiring observance of the cold storage conditions is based on the following internal documents:
• Enterprise Standard (STP-19) “Handling of medicaments requiring observance of cold storage conditions;
• Procedure (SMP-SK-16) “Transportation to company of “in bulk” medicaments requiring observance of cold storage conditions;
• Procedures (SMP-SK-17) “Transportation to distributor wholesale warehouses of finished medicaments requiring observance of cold storage conditions.
Packaging of “in bulk” medicaments (in primary package) into secondary package is in non-classified production premises equipped with two-stage air treatment system and air-conditioning system;
The packaging workshop is fit with all necessary equipment with proper identification, and approved procedures for operation and technical maintenance. The available equipment includes Labeling Machine SK-010;
Qualification procedures have been performed for the Labeling Machine SK-010, as well as for the secondary and transportation package of medicament “PEGFERON”, injections solution, 180 mg/1 ml in vials No.1 and No.5.
Product Quality Control
Quality control of in-bulk and ready-made medication products is performed on contractual terms in laboratories that are attested and accredited by the Healthcare Ministry and authorized by the State Administration on Medical Products of Ukraine to perform works in the sphere of medicines and medical products quality control.
All laboratories are equipped with state-of-art equipment for analytical and microbiological research.