Biopharma Quality Management Best Practices: An Approach To Quality Initiatives
Quality management is an increasingly important focus for biopharmaceutical manufacturers looking to avoid production problems and failures. And it’s increasingly becoming a multifaceted, industrywide concern as regulators take a closer look. With this in mind, it’s useful to see how the industry is approaching quality management in terms of the initiatives being pursued.
WHITE PAPERS & CASE STUDIES
A QbD Approach To Freeze Drying Of Cytotoxic Compounds
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward
Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs
The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, high speed lines have been designed to supply the patients with “multipurpose” small molecules drugs to cover the huge worldwide demand of health for the most common diseases. The next generation drugs will focus on the single patient and bespoke to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer. By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group
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