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
USP Guidance For Both Sides Of A Method Technology Transfer Milestone
By Louise Garone, Consulting Principal Analytical Scientist, Enterprise System Partners
Recent changes to the US Pharmacopoeia in relation to technology transfer bring positive implications for pharmaceutical manufacturing. Louise Garone of ESP discusses the Critical Path for efficient pharmaceutical development
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.
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
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.
Clinical Trial Recruitment Managers Can Be More Efficient And Reduce Costs
This case study analyzes Accel Clinical Services, its challenges associated with their CTMS system and the results achieved via the implementation of Bio-Optronics’ clinical trial management system.
Selecting An Electronic Lab Notebook: 7 Things You Must Know
Electronic lab notebooks (ELNs) are one of the primary scientific informatics solutions for helping scientists design, execute, analyze and report on experiments—but selecting the right ELN can be a challenge.