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.