Plus Group provided validation support efforts in regards to recent packaging expansion projects completed for a Major Food & Beverage Manufacturer.
Major Food & Beverage Manufacturer required additional packaging capacity at their facility. This additional capacity included approximately 20,000 ft2 of cGMP packaging space containing seven packaging lines to include bulk filling, bag filling, and bottle filling. The seven lines include new unit operations from fill point to case packaging with quality control points including weight verification / reject, X-ray/reject, and metal detection / reject.
The Plus Group Validation Department provided a Time & Material (T&M) proposal for the Commissioning and Qualification (C&Q) efforts required to bring these seven new packaging lines, the facility architectural fits and finishers, and a new HVAC unit and the associated environmental conditions into cGMP compliance.
Value Provided:
- Plus Groups Validation Specialists determined the customer’s compliance needs and then authored a plan for bringing the facility into compliance. The team then worked the plan by developing and executing the commissioning and qualification deliverables required to bring the facility expansion and the equipment systems into compliance. The validation team also leveraged their industry experience to develop the standard operating procedures required for continuing compliance prior to corporate and regulatory agency audits.