Quality Standards & Good Practices

Adhering to quality standards and good practices is a precondition to get and sustain our licence to operate

Maintaining high-quality standards is essential for our business from assuring new product approvals to maintaining our reputation with patients and health authorities. Quality is every patient’s right and every employee’s responsibility. Quality is engrained in everything we do, from concept through continuous improvement. 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 has established a quality system including sets of quality standards and procedures that employees must follow. In addition, employees must report any deviations from our standards to their Line Management or the quality function.

Roche expects that its business partners also adhere to its high-quality standards.

Patient safety and timely reporting of any adverse events and product 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 product complaints to the local regulatory and quality function.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 product complaint. A product complaint is defined as any written, electronic or oral communication from a customer/end-user that alleges a deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a Roche medical device after it is distributed to the commercial market or a clinical trial.

We are all expected to:
  • Comply with expected good quality standards and acknowledged good practices.
  • Ensure that our business partners adhere to our high-quality standards.
  • Immediately report adverse events relating to Roche medicinal products to the local safety unit.
  • Immediately report product 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.

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. You should report at least the following four elements: Patient, Reporter, Event and Product (PREP).