Galenic Laboratory GALENA LAB
The Galenic laboratory is intended for the production of galenic medicines, which are available in the product ranges of pharmacies throughout Serbia. Its operation is organized in accordance with the principles of Good Pharmacy Practice and Good Manufacturing Practice, pursuant to the decision of the Ministry of Health from November 2020.
Good practice in the production of galenic medicines (conditions regarding premises, equipment, personnel, as well as other conditions for the production of galenic medicines) is prescribed by the minister responsible for health affairs (Rulebook on the conditions for the production of galenic medicines, Official Gazette of RS 10/12).
In the galenic laboratory, only medicines from the List of Galenic Medicines used in human medicine may be produced, which is prescribed by the minister responsible for health affairs (Rulebook on galenic medicines used in human medicine, Official Gazette of RS, No. 85/11, 101/14, and 41/16).
The production of galenic medicines takes place in adequately equipped premises with a controlled movement regime for personnel and materials. Entry into the production premises for galenic medicines is strictly controlled.
Galenic medicines are produced in "cleanrooms." "Cleanrooms" are rooms with classified air, based on the concentration of airborne particles within them. Entry into the "cleanroom" area is through an airlock with mandatory changing of clothes, operator protection, and disinfection.
The process equipment is sorted by rooms based on the pharmaceutical form produced on that equipment. It is specially designed to ensure that galenic medicines are of a defined quality. The functionality of the equipment is confirmed through the validation process.
In the production processes of galenic medicines, starting materials are used that ensure the quality, safety, and efficacy of the galenic medicines.
In the premises of the galenic laboratory, which meet the highest regulatory standards, the following non-sterile pharmaceutical dosage forms are produced:
- POWDERS FOR ORAL USE
- POWDERS FOR CUTANEOUS USE
- OINTMENTS, CREAMS, GELS, AND PASTES FOR CUTANEOUS USE
- SOLUTIONS AND SUSPENSIONS FOR CUTANEOUS USE, NASAL DROPS AND NASAL SPRAYS
- SUPPOSITORIES AND VAGINAL SUPPOSITORIES
- PURIFIED WATER (AQUA PURIFICATA)
Special rooms in the galenic laboratory meet the conditions for the production of sterile pharmaceutical preparations:
- EYE DROPS, EYE OINTMENTS, EYE GELS
- STERILE SOLUTIONS APPLIED TO DAMAGED SKIN AND MUCOUS MEMBRANES
- OPHTHALMIC DIAGNOSTIC AGENTS
The labeling of galenic medicines is carried out in accordance with current regulations, pharmacopoeial requirements, and storage conditions. The method of drug application is precisely described in a way that is understandable to the patient and healthcare professional.
Quality testing of starting materials, intermediate products, and galenic medicines is performed in our own quality control laboratory. Every batch released to the market has a certificate issued after quality testing, confirming compliance with the specification for galenic medicines.
The control laboratory deals with the sampling and testing of starting materials and galenic medicines. Based on the Control Laboratory's Report on the compliance of starting materials and galenic medicines with the specifications of current pharmacopoeias, a Certificate of Analysis for the specific batch of the galenic medicine is issued.
The Galena Lab galenic laboratory has an established pharmaceutical quality system that covers all aspects affecting the quality of a galenic medicine during the production and quality control process.
Our galenic laboratory produces around 130 galenic medicines from various pharmacotherapeutic groups and for different routes of administration.
Frequently asked questions
What is a galenic medicine and how does it differ from a compounded one?
A galenic medicine is prepared in the galenic laboratory in batches and is available in pharmacies across Serbia, whereas a compounded (magistral) medicine is prepared individually on prescription for a specific patient. Only medicines from the official List of Galenic Medicines, established by the minister of health, may be prepared in a galenic laboratory.
To which standards does the Galena Lab galenic laboratory operate?
Its work is organized in accordance with the principles of Good Pharmacy Practice and Good Manufacturing Practice, pursuant to a decision of the Ministry of Health from November 2020. The conditions for preparation (premises, equipment, and staff) are set out in the Rulebook on the conditions for preparing galenic medicines.
Under what conditions are galenic medicines prepared?
Preparation takes place in suitably equipped premises with controlled movement of staff and materials, and sensitive preparations are made in clean rooms with classified air. Clean rooms are entered through an airlock, with mandatory changing of clothing, operator protection, and disinfection.
How many galenic medicines does Galena Lab prepare, and in which forms?
The galenic laboratory prepares around 130 galenic medicines from various pharmacotherapeutic groups. Non-sterile forms include powders, ointments, creams, gels and pastes, cutaneous solutions and suspensions, nasal drops and sprays, suppositories and pessaries, while sterile preparations (e.g. eye drops and ointments) are made in dedicated rooms.
How is the quality of galenic medicines controlled?
The quality of starting materials, intermediates, and galenic medicines is tested in our own quality-control laboratory. Every batch released to the market carries a certificate confirming conformity with the galenic medicine specification, within an established pharmaceutical quality system.