On capital projects, our compliance experts engage at early concept stages to implement a “Quality-by-Design” process in order to have CGMP compliance built-in to each and every design. We fully define the commissioning, qualification and validation (CQV) strategies early in the design process to assure the project specifications clearly define all deliverables and services required for successful completion of a project. We understand the regulatory nuances and apply best practices to tailor a project's deliverables to meet the expectation that the facilities and equipment are "fit for intended use."
Our best practices align with ASTM E-2500, ISPE guides, EU Annex 15 and PIC/S. We support projects from initial validation master plan (VMP) development through the completion of qualification and validation protocol execution. For new start-up companies, we provide concurrent QMS development so CGMP manufacturing activities can commence after completion of the project. Our compliance services are provided for both internal IPS projects as well as independent third-party CQV projects.
Whether part of a renovation, change control, periodic requalification or part of a continuous improvement process, IPS provides CQV and QMS support to existing operational facilities.