ISPE Product Manufacturing Quality Metrics Initiative
ISPE commenced its Quality Metrics Initiative in June 2013 after the US Food and Drug Administration (FDA) announced its Quality Metrics Program in a February 2013 Federal Register notice. To assist in the evaluation of product manufacturing quality, FDA is exploring the broader use of manufacturing quality metrics.
WHITE PAPERS & CASE STUDIES
Private Branding: How On-Demand Color Labeling Can Add Value To The Growing Generics Market
The generics market has taken off in recent years due to numerous patent expirations for brand-name companies. In light of this, pharmaceutical manufacturers, insurance companies and consumers, in search of significant cost savings, have turned towards the generics industry.
Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
Pharma Company Cuts Packaging Costs Increases Inspection Speed By 86%
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
Maik W. Jornitz, President, G-CON Manufacturing LLC
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