Quality Standards & Good Practices
Adhering to quality standards and good practices is a precondition for our licence to operate
Maintaining high-quality standards is an important part of regulatory compliance and a prerequisite for our business. Roche is committed to complying with legal and regulatory requirements, internationally acknowledged good practices, e.g. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), and to meeting the high expectations of its stakeholders regarding the quality, safety and efficacy of its products and services.
Roche expects that its business partners also adhere to its high-quality standards.
To strengthen the oversight and management of GCP/GVP, Roche has set up a Medical Compliance Committee as the governance body for medical compliance across the Pharmaceuticals Division. It is supported by the Medical Compliance Office, which ensures an integrated, aligned and coordinated medical compliance strategy.
Patient safety and timely reporting of any adverse events and customer complaints is of the utmost importance. Roche employees have been trained to, upon awareness, immediately report any adverse event to their local safety unit and any customer complaints to the local regulatory and quality function, regardless of whether the employee becomes aware of it during or outside of work and regardless of the communication channel (e.g. in person, via social media).
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a Roche pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event may include but is not limited to drug overdose (accidental or intentional), death, drug abuse, pregnancy, lack of efficacy or withdrawal symptoms.
Medical device reporting requires the reporting of any customer complaint. A customer complaint is defined as any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a Roche medical device after it is released for distribution.