Strong Data Is Generated By Strong People
By Joanna Gallant, Joanna Gallant Training Associates
In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them.
WHITE PAPERS & CASE STUDIES
Medical Device Package Inspection Case Study
Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products.
Pharmaceutical Company Cuts Packaging Costs
In tough economic times, First Priority, manufacturer of generic veterinary pharmaceutical products, decided it was time to take a hard look at where they could cut costs without compromising on efficiencies and quality of their products.
Be In Control Of Product Quality – Do Not Just Rely, But Understand
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
The Sizing Of Non-Spherical, Sub-Micron Particles Using Polarization Intensity Differential Scattering (PIDS™)
Nearly all laser-based particle-sizing devices make no allowance for the shape of the materials under test, regardless of the size of the particles. The reason for this lies with the underlying assumptions used for calculating size distributions from the raw data generated during the analysis.
Determination Of Cell Aggregation In Bacteria Cultures With An Automatic And Reliable Method
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as Electrical Sensing Zone (ESZ) technique. The ISO International Standard 13319 describes this technique. By Andres Lobeiras, Product Manager, Beckman Coulter, Inc