Contact All Suppliers
Drug Qualification
Drug qualification is an essential part of the drug development process. Qualification includes the following steps: Design qualification (DQ)- Shows that the proposed design will adhere to all the requirements that are outlined in the User Requirements Specification (URS). Execution of the DQ is a mandatory requirement before construction of the new design can be more
Drug qualification is an essential part of the drug development process. Qualification includes the following steps: Design qualification (DQ)- Shows that the proposed design will adhere to all the requirements that are outlined in the User Requirements Specification (URS). Execution of the DQ is a mandatory requirement before construction of the new design can be authorised. Installation qualification (IQ) – Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place. Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly. Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time. Component qualification (CQ) – is a relatively new term developed in 2005. This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
Validation Life cycle Management System
ValGenesis is the global leader in providing 100% paperless Electronic...
USASouth San FranciscoTools for Pharmaceutical and Biotech Laboratories
Eppendorf offer laboratory tools for the pharmaceutical and biotech industries....
GermanyHamburgControlled Lab Reactor for R&D and Scale-up
From development to piloting and process control technology, we offer our...
SwitzerlandRüschlikonContract GMP Auditing, GMP Systems, Management of Regular Inspections
Ulverston GMP Consulting Ltd specialises in the design, assessment and...
United KingdomBarrow-in-FurnessQualification and Validation of manufacturing and laboratory equipment
Valicare is a service company offering support in the area of Qualification and...
GermanyHörselbergPharmaceutical Development Service
Vectura is an emerging pharmaceutical company that is developing a range of...
United KingdomChippenham
-
Vectura Group Plc Vectura is an emerging pharmaceutical company that is developing a range of inhaled drugs for the tr...
-
Valicare GmbH Valicare is a service company offering support in the area of Qualification and Validation of manufa...
-
Eppendorf Eppendorf offer laboratory tools for the pharmaceutical and biotech industries. Products include pip...