USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
In September, the US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.
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.
How To Calculate The Total Cost Of In-Line Metal Detection Equipment
Considering TCO helps to better understand the costs over and above the purchase price and also – when suppliers have differing offers – to compare them and ultimately to substantiate the investment decision.
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.
Striving For Label Perfection In Clinical Trials
No other labeling process in the pharmaceutical industry is as complex as clinical trial labeling. Clintrak Clinical Labeling Services knows this first hand and has been committed to finding a way to reduce the amount of time and money spent on proofreading in order to improve their process.
Catalent Approves A Proof Within Hours, As Opposed To Days With Digitial-Page
A recent FDA regulation revision has had pharmaceutical packagers scrambling to fine-tune their process. It is now more important than ever for pharmaceutical packagers, such as Catalent, to ensure processes are operating as efficiently as possible.
Improving Quality Processes For Medical Device Development And Manufacturing
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.