LUNARIA is equipped with analytical instruments enabling quality control of various products within the scope required by valid pharmacopoeias (Ph.Eur., USP) and according to specifications which are parts of the registration documentation.
Our activities are GMP certified. We have state-of-the-art analytical equipment and excellent facilities for the storage and administration of stability samples. Our climatic boxes benefit from the latest technology and are constantly monitored by a UPS-backed Electronic Data Storage/Printer System, a program that advises our managers if conditions go beyond the parameters laid down in specifications. The Alarm System, a PC/internet/mobile system with an individual backup generator, runs 24 hours per day, which assures that the system will continue to function even in the event of power cuts. We have a 7-days-per-week maintenance/service agreement with our suppliers. We are ready to manage your stability studies.
At any stage of the development, during production, or as long as a product is on the market, the good characterization of ingredients or formulated products is essential. LUNARIA has a number of years of experience in this field and is used to evaluating the safety, identity, strength, quality and purity of pharmaceutical products.
We know that such a process is critical: first, from the patients’ point of view, since their health is concerned, but also from the point of view of time management, as products must reach the market faster than ever. LUNARIA offers is the comprehensive management of data and procedures which ensures that the process is flawless and provides you with the confidence that your product meets all regulatory specifications.
LUNARIA prepares stability study plan for each new stability study. The plan is prepared separately for each studied batch and contains identification of the batch, storage conditions, sampling time points, product specification, methods of analysis to be used for particular test, number of packages necessary for each stability time point, study start date and approval of the plan by LUNARIA and customer.
We prepare and implement also the customer designed stability protocols or plans to meet specific needs of our customers.
The protocols and plans conform with the GMP requirements.
Our climatic chambers conditions are constantly monitored and recorded. There is a UPS-backed up Electronic Alarm System advising our managers if conditions go beyond the parameters laid down in specifications. This Alarm System uses PC/ internet / mobile system runs 24 hours per day, which assures that the system will continue to function even in the event of powercut.
We have a 7-days-per-week maintenance/ service agreement with our suppliers. We are ready to manage your stability studies.
LUNARIA performs the photostability studies according to ICH Q1B using the photostability chamber set at 25 °C/60 % RH with sensors calculating the total illumination and automated turning off of the UV and VIS lamps after reaching the required dose.
For the forced degradation studies of small amounts of samples we use separate instrument with illumination time lower than 24 hours.
We can also perform cyclic studies. We can combine them with our ASAPprime® studies.
We have free capacity in our own chambers, walk-in chambers (from Thermotec) with alarm systems and back-ups for following conditions:
LUNARIA performs analyses according to the methods stated in the registration documentation to ensure the quality of the product meets the release specifications. The results of the analyses are summarized in the Certificate of analysis.
We can offer you also the service of the Qualified person for release of your product onto the EU market.
LUNARIA has long term experience with analyses of the high number of process validation samples for e.g. blend uniformity, content uniformity and dissolution profiles in very short terms to meet customer needs for information about the repeatability of the manufacturing process.
Methods which are not validated at LUNARIA are subject to method transfer prior their use for the quality control analyses. The method transfer consists of method verification analyses, to confirm the performance of the method in LUNARIA laboratories, method transfer protocol preparation and approval, method transfer analyses followed by method transfer report.
LUNARIA either prepares own method transfer protocol and report according to our SOP or we incorporate the customer designed protocol and report.