Obligations of suppliers to the pharmaceutical industry, biotechnology and medical technology
Pharmaceutical, biotechnological and medical technological companies must comply with regulatory requirements. The current authorities in charge and the notified bodies control those companies with audits and inspections.
Each supplier of these industries is working as an extended but integrated service of its costumer. Therefore, the supplier is liable to the same regulatory requirements as the pharmaceutical, biotechnological or medical technological company.
On the other hand, the regulated company is responsible that the supplier is well prepared for these tasks and passes such audits and inspections.
First of all, the processes, production, and IT of the company and the supplier have to be validated. That means the whole process chain in all steps within and between the companies!
The supporting software and hardware must be validated as well as the underlying IT infrastructure with its qualification.
With all these validation and qualification issues the company has to give guidance to its supplier. The main goal is to use the supplier’s existing processes and documentation. The company is responsible to check everything against the validation and qualification processes and documentation. Gaps and differences must be identified and brought to solution.
For the cooperation with the supplier the normal contracts and service level agreements (SLAs) are insufficient. The company has to set up a specific quality assurance agreement (QAA) which covers all regulatory topics not mentioned in the standard contract and / or the SLA.
As an important part of the training for regulated affairs supplier audits shall be conducted. At the beginning of the cooperation an inhouse audit at the supplier shall be organized by the company. It is regulatory stated to repeat the audits on a regular basis i.e. once a year.
As soon as all these issues have been considered nothing endangers a good and long-lasting cooperation between the company and the supplier –
to be well prepared for audits!
#Softwaretest #QS #CSV
