Galenica is expanding further and is looking for a Vice President Research & Development. For more information click here.
A team of Galenica collegues will be attending CPhI Worldwide in Frankfurt on 24th to 26th October 2017. To arrange a meeting during the event please contact email@example.com.
In collaboration with Invest in Skåne we will be exhibiting at Arab Health 2017 in Dubai. Visit us at booth C40 in hall Z6. For more information please click on the link below.
For the second year in a row Galenica will be exhibiting at the EADV Congress. The exhibition will take place on 29 September to 2 October at the Austria Center in central Vienna, Austria. Meet us at booth 16a where the Galenica team will be presenting our product Ovixan®/Ovison®. This year we will share the booth with our Italian partner Abiogen Pharma and Swiss partner Gebro Pharma.
A team of Galenica collegues will be attending CPhI Worldwide in Madrid on 13th to 15th October 2015. To arrange a meeting during the event please contact firstname.lastname@example.org.
For an outsider, the recurring audits that take place at a formulation company could easily be perceived as disrupting and distracting. Nothing could be more wrong. At Galenica we consider these frequent audits as important and highly useful tools in our never-ending efforts to improve the quality of our products and services.
Audits and inspections are common, not only because the pharmaceutical industry is closely regulated by national authorities, but also since buyers have an obligation to audit their subcontractors. Hence, our operations are more or less constantly being evaluated by existing or potential clients.
The general objective for all audits is to assure that the subcontractor’s products or services are up to standards and fulfill the required quality. Basically every aspect of the operations is scrutinized – from general production processes and procedures for documentation to the expertise and experience of the personnel and the quality of the premises and equipment. Results and issues are then penetrated in close collaboration with the client and, if need be, addressed in a suitable manner.
Yet, not two audits are identical. There is no blueprint for this process, so all clients have somewhat different requirements depending on the nature of their project.
Having our business meticulously examined from almost every imaginable angle forces us to consider and re-consider how we plan, organize, execute and document all our work and processes. A single audit seldom brings about great or revolutionary changes in the way the operations are run. But they regularly generate improvements; small steps in the continuous efforts to enhance and secure the quality in our offering.
Audits can never be regarded as a burden or a nuisance. On the contrary, without the frequent audits it would be a lot more difficult to reach the high standards and great quality our clients expect from us.
There are numerous reasons why pharmaceutical companies at some point turn to an outsourcing solution provider. It can be a matter of streamlining operations, cutting time to market or reducing costs. Last but not least, outsourcing laboratory services is a quick and efficient way to gain access to special capabilities and expert knowledge.
Analytical service is no exception.
Now, let’s look at some of the issues and challenges that are significant for pharmaceutical analytical chemistry.
Characterization of a new active pharmaceutical ingredient, API, requires a battery of methods and techniques. To analyze how the very same API works, responds or degrades in a formulation, normally calls for a totally different toolbox.
Running an analysis on API alone is a quite straightforward operation because the sample is very pure. After formulation, on the other hand, the API must be extracted before it can be analyzed. This can sometimes be a rather tricky and time consuming operation, highly dependent on dosage form.
The chemical stability must be studied to determine, for instance, the expected shelf-life of the drug. To do so, samples must be taken, in which all of the API as well as all possible degradation products are accounted for with high accuracy.
All excipients have an impact on the API. A combination of two or more excipients can produce yet another response that will affect the stability or efficacy of the medication. Even though many APIs are similar and have common chemical traits, each and everyone require its own analysis. Likewise, any change in the mix of excipients may introduce new analytical challenges.
The fine art of pharmaceutical analysis is not so much a question of knowing what kind or how much of an API that goes into a formulation, but rather making sure that all of it always can be traced at any time.