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.

We are all expected to:
  • Comply with legal and regulatory requirements as well as internationally acknowledged good practices.
  • Ensure that our business partners adhere to our high-quality standards.
  • Immediately report adverse events relating to Roche pharmaceutical products to the local safety unit.
  • Immediately report customer complaints relating to Roche medical devices to the local regulatory and quality function.
Questions & Answers

I work on a production line. What should I do if I notice that some finished products coming off the line do not meet Roche quality standards?

The Roche brand stands for products of high quality. If you notice products that do not meet Roche standards, follow the processes as defined in the applicable documentation and if necessary inform your Line Manager and experts from the quality assurance departments. Make sure that the necessary steps are taken.

A healthcare professional with whom I interact regularly at work calls me and mentions that a patient of hers on Roche drug X was recently hospitalised with pneumonia and died. Do I have to report that?

Yes. This adverse event should immediately be reported to the local safety unit.

While surfing the internet, I discover a social media site on which a patient mentions that he experienced blurred vision after taking Roche drug Y. Do I have to report that?

Yes. If you become aware of such information, you should report it to the local safety unit. This includes information from non-Roche-owned websites.

In case of an adverse event, what do I need to report?

In case of an adverse event you should report at least the following four elements: Patient, Reporter, Event and Product (PREP).

Further Informations