Deblistering Machine Qualification

Overview

A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not related to product quality (e.g.… more


Qualification of Cell Culture Purification Suite

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 quality control lab facility, and changes to their utility systems to accommodate the resultant increased production rates.… more


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 for continued packaging operations during construction and qualification activities.… more


Hospital Building Commissioning

The Challenge

A client contacted Performance Validation requesting assistance with commissioning of a pediatric research center renovation project.  The research center was to be located within a renovated 2nd floor of an old building that is part of a children’s hospital and was to include exam space for patients participating in clinical research programs as well as space for research labs, lab support, offices, and staff support. … more


Data Integrity Assessment Project Summary

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The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity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 practices. … more


Microsoft R Validation Project Summary

The Challenge

A medical device manufacturing client contracted Performance Validation (PV) to assist with creating a Computer System Validation (CSV) package for Microsoft R. Finding evidence of other organizations validating R for GXP compliance did not prove fruitful.  Microsoft R is a free, open source application which uses the S language in statistical methodology.… more


Finished 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. … more


Validation of Ignition SCADA (Inductive Automation) System for Medical Device Assembly

A leading medical device manufacturer introduced a new production line to their assembly facility.  The new line was designed to accommodate the simultaneous production of several makes and models of hand-held motor-driven surgical devices.  This new line was designed to apply the latest integrated manufacturing technology to optimize flexibility, efficiency, quality controls, and real-time accountability toward meeting immediate market demand for product.  … more


Medical Device Programming System Validation

The service engineering department of a leading medical device manufacturer developed a fully custom medical device programming system for distribution to its global service centers.  This new programming system was a down-scaled version of a larger and more complex automated system that the client used in production for the testing and programming of electronically driven motorized surgical devices.more


FMEA Training

The Challenge

A biomedical research company sought to increase worker knowledge in the use and application of the Failure Mode Effects Analysis (FMEA) quality tool.  The company desired a pragmatic approach with a combination of theoretical understanding of how the tool might be used, and a practical application of the use of the tool with one or more current products.… more