GxP Lifeline

Making the Transition to an E-System

This is the first part of a two part article.

Final FDA Rule on Dietary Supplements (21 CFR Part 111) Guidance

In June 2007, the U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.

FDA 21 CFR Part 11 And Predicate Rules Article

Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

21 CFR Part 11 and Predicate Rules of FDA, What to Know

Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

The Effect of Quality Management on Compliance with European Union GMP Standards

How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world's pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012.

Electronic Submission Issues, FDA Listens to Public Input, GxP Lifeline

Effective Records: Get Them Right by Getting Proactive with Vendors and Suppliers

Poor records – and poor management of good records – can trigger needless costs, penalties, and public embarrassment for FDA-regulated companies. And if managing your own records isn’t challenging enough, FDA holds you equally responsible for ensuring the quality of records generated by your suppliers, contractors, and vendors.

Establishing and Operating an Effective GMP Auditing Program

By Robert L. Dana

New Document Management System Scanning Interface - GxP Lifeline

GxP Lifeline - How to Solve Top Five Document Management Challenges

How to Solve Top Five Document Management Challenges - GxP Lifeline

Document management is such a fundamental need in any FDA compliance effort, and it poses so many challenges, that we could easily discuss the ?top 20? or more problems that plague life science companies. But in the interest of space, here are the top five document control issues that most companies complain about and some tips on solving them.

GxP Lifeline - Five Top Deviation Management Challenges

MasterControl Deviations Management Software helps ensure FDA compliance.

Essential Elements of Effective CAPA Systems - Death by CAPA

The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

Introduction to the eCTD - GxP Lifeline

The CTD (Common Technical Document) was proposed by the ICH working committee (the International Conference on Harmonisation) back in the early 1990s and finally agreed upon in November 2000. Its purpose was to provide life sciences companies with a common structure for registering drugs for human use to the regulatory agencies. The FDA was the first agency to adopt the CTD as a common structure for receiving product registrations from companies. Although the CTD submissions were initially deliv

Five Things to Expect from a Compliance Software Vendor - GxP Lifeline

The advent of JetBlue's Customer Bill of Rights has increased public awareness about the consumer's fundamental right to get his or her money's worth. Whether you're buying an airline ticket or a car, you should know what you can expect from the seller.Let's apply this concept to life science companies purchasing software for managing the content derived from their GxP processes. In the February issue of this newsletter, we discussed the things that a life science end user should consider, namel

Solutions for Most Common Change Control Issues Face by Life Science Companies

1. Inefficient System of Communication. You need effective communication to be able to implement change properly. For a company that relies on a paper-based or partially electronic system, this is the typical scenario: Once or twice a week, up to 15 people who constitute the Change Control Board meet for two hours each time to discuss engineering and other document changes. Before and after each meeting, documents are routed using the inter-office mail system or via e-mail. The problem wi

How to Solve the Top Five Batch Record Challenges

By Oliver Wolf

Shook Up Without QA: A Brief Look At The 24th Annual SQA Meeting

Another well-attended and enlightening annual meeting of the Society of Quality Assurance (SQA) was held on April 20-25, 2008 in Memphis, Tennessee. In keeping up with the theme of "All Shook Up Without QA," the meeting offered the state-of-the-art experience in promoting and advancing the principles and knowledge of quality assurance essential to regulated research in the human, animal and environmental health sciences. For those that have never attended an SQA annual meeting, this year's meeti

How to Solve the Top Five Complaint-Handling Challenges

Consumer complaints are at the heart of every product recall. Whether it's Merck's voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints.The reporting of side effects or adverse events is incorporated in FDA regulations. The agency operates MedWatch, a safety information and adverse-event reporting program that allows health-care professionals and the public to report serious probl

Adopting Technology In The Life Science Industry Article

By Curt Porritt