Integrated Facility Management (IFM) outsourcing companies don’t operate within a Quality Management System (QMS) and lack the knowledge and experience required to manage GMP utilities in a manner that will ensure regulatory compliance. These shortcomings can result in additional costs for monitoring and controlling these utilities, production downtime when systems operate outside control limits, and Corrective and Preventive Actions (CAPAs) that lack proper investigation and documentation.
Achieving your IFM expectations requires that your IFM suppliers partner with a qualified company to manage your GMP utilities, one that has demonstrated expertise managing such utilities, operates within a QMS, and has the trained and knowledgeable resources to reliably perform duties and ensure GMP compliance.
Mentor Technical Group (MTG) is a GMP utilities management supplier with the necessary tools, know–how, experience, successful track record, and global capabilities to partner with your IFM integrator and provide a complete GMP utilities management program and solution, including experienced and trained resources, as well as compliance training within an established QMS.
An Integrated Solution
By ensuring that your GMP utilities are, first, available on–demand and, second, monitored and controlled within established specifications at the lowest possible operating cost, MTG can provide you with the kind of integrated GMP utilities management solution that will help you achieve optimum operating efficiencies.
According to the website of the International Society for Pharmaceutical Engineering (ISPE), “GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.”
Because GMP regulations require such companies to exercise a high level of quality control, compliance helps reduce or eliminate the incidence of contamination, confusion, and errors, which, in turn, helps reduce or eliminate the possibility that ineffective—or even dangerous— products may reach the consumer. The consequences for companies that fail to comply with GMP regulations can be dire—including such punitive measures as recall, seizure, fines, and jail time.
GMP utilities are defined as utilities that are documented in a QMS, have validated quality specifications, come in direct contact with the product, can adulterate product integrity, and require continuous monitoring and control. Commonly used GMP utilities include HVAC for Manufacturing Areas (HEPA–filtered air), including Clean Rooms and Sterile Filling Equipment; Process Water, including United States Pharmacopeia (USP) and Water for Injection (WFI); Compressed Air; Pure Steam; Process Gases; and Vacuum.
These utilities must be operated and aligned with the Standard Operating Procedures (SOPs) designated in the QMS and the guidelines defined in US FDA Title 21CFR 211, 820, and 600, and require documentation verifying that they are continuously operating within the control range, along with deviation reports identifying any non–conformance events outside of the control ranges that can generate Corrective and Preventive Actions (CAPAs), create Stop Production Notifications (SPNs), and result in product recall.
MTG is an IFM GMP utilities partner for leading life science companies that operates within an established FDA/ISO certified QMS; has established a highly successful track record managing GMP utilities; is a single–source supplier, thus eliminating duplicate efforts and costs; has extensive experience with tracking and trending operating performance; is well–versed in change control management; and comes equipped with a state–of–the–art in–house metrology laboratory to provide top–level calibration support.
As a preferred GMP utilities supplier for more than ten years, MTG has partnered with IFM companies and provided tailored GMP utilities management solutions for such industry leaders as Amgen, Janssen, Lilly, McNeil, Merck, Ortho, Pfizer, and Roche, among others.
When you partner MTG with your IFM company, you enjoy all the following benefits:
- Reduced Cost (because redundant work is eliminated).
- Reduced CAPAs (because miscommunication is reduced).
- Proactive Compliance Monitoring (through periodic internal audits).
- Improved Proactive Alarm Response.
- Single–Source GMP Utilities Data Filing.
- Single–Source Investigation Analyses.
- Certified Calibration Assessment Program.
- Optimum Operating Efficiencies.
Our Added–Value Proposition
At MTG, we see ourselves as a global partner committed to meeting or exceeding all of your GMP utilities requirements. And we go a giant step further by providing you with a complete, one–stop solution, thus ensuring that you maintain GMP utilities compliance based upon demonstrated performance and continuous improvement, while enjoying reduced cost through consolidation.
Contact Us Today
Our job is to create and manage a GMP utilities program that ensures your compliance with all applicable regulations and requirements. Give us the opportunity and we’ll get the job done.