Integrated Quality Services/
Throughout The Products’ Lifecycle
QUALITY CONTROL/ POST APPROVAL SERVICES
Batch Testing/ Release of API’s, Excipients, Packaging and Final Products
Qualimetrix is GMP approved to perform routine testing and release of APIs, excipients, packaging and final products (chemical and biological). This activity also involves batch release testing, for products manufactured outside of the EU which are planned for importation and release within the European market (EU testing).
QP services include the release of Final Products to the market, but also Audits to API and final products manufacturers, third party subcontractors and suppliers.
Post approval (ongoing) stability studies
The stability of a final product should be monitored according to a continuous and appropriate program that will permit the detection of any stability issue (e.g. changes in levels of degradation products). The purpose of the ongoing stability program is to monitor the final product and to determine that the final product remains, and can be expected to remain, within specifications under the storage conditions indicated on the label.
Post Approval Management/ Lifecycle strategy
According to the ICH Q10 and Q12 principles, harmonized tools to facilitate prospective changes over the products’ lifecycle should be applied. Our services concern a systematic approach to proposing, evaluating, approving, implementing and reviewing changes, such as manufacturing and/or release site; API, excipients and/or packaging supplier; manufacturing process; analytical methods and design space.