|Home||GMP Engineering||GMP Maintenance||GMP Calibration||Training & Seminars||GMP Compliance Audits||Contact & About Us|
Compliant Project Engineering
Project Engineering is an early step in the process to create a new process or facility, or modify an existing one - and must recognize the compliance aspects of the project! After provided with User Requirement Specifications (URS), the engineers have to layout, design, specify, select, install, commission, and often help qualify the equipment. This process should not be done apart from the other departments charged with validating, operating, and maintaining the process or facility.
To comply with 21CFR 211.42, Design and construction features, an organization would be wise to establish procedures that incorporate reviews by relevant functions. Reviews that are better done when corrections can be made on paper, rather than the much more time-consuming and costly changes to bricks and mortar.
Additional requirements for a Compliant Project Engineering Program are outlined in our white paper: A Complaint Engineering Program - CONSIDERATIONS.
PTS has helped clients establish project engineering procedures that ensure appropriate reviews along the process, yet recognizes that the project to replace a WFI pump would not require as extensive a review process as constructing a new processing facility. Compliant, yet pragmatic, is the continuing theme in developing such procedures - a theme PTS always keeps in the forefront.
PTS is ready to help your organization establish a sustainable program for controlling your Project Engineering function.
To help visualize the requirements for installing and operation of a facility or process (from complaint engineering view) the graphic below is offered.
© Pharmaceutical Technical Services 2015