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.