All our QPs (Qualified Person) provide GMP Compliance support both internally and externally across all of eXmoor’s client portfolio and are experienced in being able to interpret regulatory guidance requirements including the EU, US, PIC/s, and apply this to an individual client’s needs. Key to this is the development of a coherent suite of GMP compliance and qualification documentation aimed at ensuring and demonstrating regulatory compliance from concept through qualification to successful regulatory licencing.
The URB (User Requirement Brief) is the starting point on this journey. Every facility concept design ends with a full quality review against both detailed GMP standards and the URB, ensuring that the proposed design meets both user and regulatory expectations. This is normally followed by a presentation of the concept design to the Competent Authority. We help our clients define the qualification and validation strategy for the whole project. The compliance team has experience in developing a detailed Validation Master Plan (VMP) ensuring a solid and comprehensive foundation is laid in accordance with regulatory expectations.
User Requirement Specifications (URS) are written for Direct Impact Systems in collaboration with our team of process engineers. We can ensure essential elements of quality are built in at this stage. The URS is used as a point of reference throughout the qualification stages and through into full operational use.
Our compliance team can help you oversee the ongoing qualification process from design qualification through installation qualification, operational qualification and performance qualification for equipment, facilities, utilities or systems.
We can also support the review of existing and development of new Pharmaceutical Quality Systems (PQS) either in association with a new capital project or as a standalone project. We can perform audits of medicinal product manufacturers, contract test houses and material suppliers to support the qualification of suppliers for our clients.
GMP auditing is a key part of any manufacturers PQS and provides assurance that the suppliers are managed and controlled. Our experience of working with all the relevant regulatory Agencies enables us to provide an audit that is focused on client needs and takes into account the Regulators’ concerns.