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.
At some stages pharmaceutical research and development is a question of trial and error. But when it comes to clinical trials there is no room left for mistakes. Even the slightest suspicion of a mix-up of substances, documented results or test subjects can be reason enough to scrap an entire trial project, provoking great expenses as well as losses in time to market and reputation.
Consequently, there are continuous efforts in clinical trials supplies to make the handling safer and the logistics more reliable. The aim is to ensure that each site and each patient is supplied with the right medication, in the right quantity at the right time.
NEW: Packing and labeling
Risks can, of course, be reduced in many different ways. One way to enhance control and ease management concerns is simply by decreasing the number of players involved in the supply chain. As a part of this effort, we at Galenica recently decided to extend our offering to also include packaging and labeling of clinical trials supplies and we now fulfill all relevant regulatory standards and have acquired the necessary permissions.
Keeping some of the work stages within our own premises bring several improvements to the operations. Naturally, it is easier to supervise and control all details if the packaging and labeling process takes place in-house and can be executed in one single uninterrupted sequence. This is especially valuable if the trials are complex and distributed over both time and space.
Being able to avoid shipping to and from another Contract Research Organization in charge of packaging and/or labeling has several advantages. Not only will it decrease the risk of goods getting mixed-up or instructions being misunderstood. In addition, each transport means that the medicinal preparations will leave a closely monitored indoor climate and risk – by negligence, lack of judgment or bad luck – being exposed to cold, heat, humidity or careless handling.
These measures and procedures do not make our system absolutely foolproof, but it takes our clients one step closer to trials without errors.
The jury’s motivation:
“Since its inception in 1999 the company has developed positively, which has led to Galenica today being one of Europe’s most competent CROs focusing on galenic development. The company has now taken a step forward by developing its own products. The first product – a new and improved cream for the treatment of psoriasis and eczema – was recently launched.”
Galenica AB has developed and is launching Ovixan®, a cream formulation for the treatment of psoriasis and eczema. The clinical development program has been successfully completed and the product was approved in all the Nordic countries during Q1 2012. The trade name (Ovixan, a prescription drug) has been registered and patents are pending. The new and improved cream preparation, which is indicated for both psoriasis and eczema, will offer a number of patient benefits compared to existing cream formulations leading to improved compliance. Galenica will launch the product in all the Nordic countries during 2012–13. For more information about Ovixan please see the ”SUMMARY OF PRODUCT CHARACTERISTICS” or Fass.se.