The Challenge The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity issues among FDA regulated industries. As a result, companies in the affected industries have begun instituting or updating their data integrity policies and best […]
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Trackwise Project Summary
The Challenge A leading medical device company was underway on two projects intending to launch new global business information systems; an electronic CAPA management system and a product complaint handling system. Both systems were being developed in a TrackWise® system environment with the collaboration of the software vendor, Sparta Systems, and the in-house development team. […]
Read MoreProcess Automation Upgrade in an Animal Health Manufacturing Facility
The Challenge A large Midwestern animal health manufacturing company needed to move from an old process control automation platform with diminishing upgrade and support options to a newer more customizable and expandable system. The same automation platform was being used for all of the major manufacturing processes at the plant site, from fermentation to recovery […]
Read MoreManual to Automated Process Improvement
Clinical Trials Manufacturing – Conversion of a Manual to Automated Process The Challenge A Contract Manufacturing Organization (CMO) required a process improvement to increase the production capacity for prefilled syringe assembly and labeling operations. This parenteral assembly, labeling, and packaging process was currently being performed manually, but due to forecasted volume increases, an automated process […]
Read MoreDry Product Packaging Line Qualification
The Challenge A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow […]
Read MoreCell Culture Purification Suite Qualification
The Challenge A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window. Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their […]
Read MoreFinished Drug Product Distribution Warehouse Commissioning
The Challenge A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis. The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area. The project was part of a pilot project delivery method and involved adapting an […]
Read MoreBlister Card Packaging Line Qualification
The Challenge A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new blister card packaging line for a new product launch, as well as facility and utility modifications to support the new packaging line. The packaging line was intended primarily for a new product that was […]
Read MoreNon-Destructive Leak Tester Qualification
The Challenge A Midwestern pharmaceutical company planned to upgrade their in-process checks for blister card integrity from a destructive blue dye leak test to a non-destructive, vision system-based leak test. The existing blue dye leak test required that all tested blister cards be discarded even if they passed. This caused the customer to lose money […]
Read MoreDNA Based Diagnostic Project
The Challenge A Midwestern diagnostic company desired to bring a DNA based diagnostic to market as an FDA approved medical device. The device would be cleared through the FDA PMA approach and would be the companies first FDA approved medical device. A parallel submission (FDA/CMS) would be utilized. The technology represented an innovative, groundbreaking approach […]
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