How Reliable Is The Pharma Equipment You Buy?
When it comes to equipment manufacturing in the pharmaceutical industry, it is imperative that a product functions exactly as it was intended. Any misstep caused by faulty equipment could have catastrophic results for the company that produces a drug, but more importantly, for the patient who uses it. The serious consequences that can result from a lack of accurate equipment design and the associated manufacturing processes are why Donald Dobert, president and COO of ATL Pharmaceutical/Medical, created his company’s New Product Development (NPD) Planning Process.
WHITE PAPERS & CASE STUDIES
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
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.
Pharmaceutical CGMPs For The 21st Century: A Risk-Based Approach
The following questions and answers were prepared by MasterControl Inc., a leading provider of quality management software solutions for FDA-regulated industries and ISO-adherent companies.
The Pharmaceutical Industry’s Transition To Electronic Processes
Any account, however brief, of the pharmaceutical industry’s transition to electronic processes would be incomplete without first mentioning the International Conference on Harmonisation (ICH). The ICH was formed in 1989 to standardize formats for new drug applications in the U.S., Europe, and Japan (at that time, the majority of new medicines were developed by these countries). The ICH not only established the common technical document (CTD) format, but, as early as 1994, began developing the Electronic Standards for the Transfer of Regulatory Information (ESTRI) to meet the requirements of both pharmaceutical companies and regulatory agencies.
How To Avoid The Top 5 LIMS Nightmares
Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.