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Additional Links Contact Us- Phone: +1 (800) 811-6990
- Toll-Free: +1 (800) 811-6990
- Europe: (514) 337-6990
- Fax: +1 (514) 335-0801
- Email: [email protected]
RELATED PRODUCT BRANDS
ProMach offers more than a century of experience in designing, manufacturing, integrating, and supporting the most sophisticated and advanced pharmaceutical and medical packaging solutions in the marketplace. ProMach’s technologies can meet the most challenging requirements with minimal downtime, higher productivity, and true pharmaceutical packaging performance, with compliance built right in.
EXPLORE OTHER PROMACH BUSINESS LINES
ProMach is your partner from start to finish. Our product brands are grouped into distinct business lines that make the most sense to our customers, covering every function of the production line: Filling, Bottling & Capping, Decorative Labeling, Flexibles & Trays, Pharma, Handling & Sterilizing, Labeling & Coding, Robotics & End of Line, and Systems & Integration.
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Validation
NJM offers complete FDA or GAMP5 validation and compliance assistance to customers for an individual machine or an entire line. The qualification services offered include:
- Design Specifications Development (URS, FDS, HDS, SDS, etc.)
- IQOQ / PQ Protocols Generation and Implementation
- SOP Development and Review
- FAT / SAT Protocols Generation and Implementation
Working with experienced validation professionals, NJM uses an efficient, systematic approach to documentation in order to prepare qualification protocols while the equipment is being designed and assembled. Protocols are submitted for review and approval prior to equipment delivery. NJM employs a very pragmatic approach to protocol execution in order to fulfill all regulatory documentation requirements quickly and efficiently thus enabling customers to begin using equipment for production in the shortest time possible.
On-site implementation services are also offered by NJM.
