Commissioning Qualification Validation (CQV) for new project installations, or for used – refurbished equipment including mechanical seals, and seal support systems.
Projects associated with annual shutdowns, including health checks on seals for critical assets, in line with plant protocol.
Commissioning & Validation
The importance of commissioning and validation in the Pharmaceutical, BioPharma, and Live Science sectors. Through rigorously checking and testing, pharmaceutical validation creates a documented evidence trail that demonstrates that a system, a procedure, or a process used in the production and testing of pharmaceutical products can maintain compliance at all stages. The validation leads to consistent and repeatable results in the production of pharmaceutical products.
The key point, there must be “documented scientific proof of consistent performance “.
Commission and Qualification
is one part of a larger validation process for making sure that a facility – and the equipment in it – will function as required and be approved by the regulatory agencies that have jurisdiction over that facility.
An Equipment Validation Protocol is a written plan, stating how validation will be conducted including test parameters, product characteristics, production equipment, and decision points on what constitutes an acceptable result.
IQ OQ PQ
or Installation Qualification Operational Qualification, and Performance Qualification are 3 independent and documented procedures used together (when executing a validation protocol) to check and test that a mechanical or software system is;
• installed correctly
• meets its design requirements and specifications
• operates how it was designed under load
Commissioning, Qualification and Validation is a very detailed-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment /systems into use.SMIDDY(IMSC)Ltdprovides CQV engineering services direct to Pharmaceutical, BioPharma, and Live Science sectors, and to project management companies, for new and existing projects.
Please contact SMIDDY(IMSC)Ltd. to discuss your CQV project requirements. We are flexible and work with commissioning teams from beginning to end or for support on specific projects. We are happy to accommodate short-term contracts.
Please contact SMIDDY(IMSC)Ltd:
info@smiddy.ie
www.smiddy.ie
Phone: 00353 214321608
Copyright Info
Copyright – John Smiddy 2021
