Manufacturing

Production Stages

•  Receipt of “in bulk” products;
•  Incoming check for products and printed package materials;
•  Sanitary preparation of production facilities;
•  Preparation of raw materials and other materials;
•  Labeling;
•  Secondary packaging into packs and transportation boxes;
•  Quality control for finished products;
•  Issues of sales permit.

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.

Production Facilities

• Package Workshop is located at 2-nd floor of a separate 2-floor production-warehousing building. Total area of production, support and household premises is 752 m2;
• All necessary parameters in production premises are ensured by an individual plenum-and-exhaust ventilation system, which is independent from other departments of same building and includes two purification levels (G4 and F9). Temperature in all premises is maintained within 18-250С, with relative humidity not exceeding 65%;
• Warehouse facilities include separate areas for storage of raw materials, packaging materials, finished products and rejected products;
• Medicaments requiring special cold storage conditions are kept in special certified cold storage chambers.

Cold Storage

• Equipment

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;

• Personnel

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.

• Documentation

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 Process

• Premises

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;

• Equipment

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 and Validation

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.
 

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