Bioprocessing White Papers

  1. Complaint Handling As An Integral Part Of FDA And ISO Compliance

    Organizations, especially businesses, exist because of their customers. There are two types of customers — external (i.e., paying clients, general public) and internal (people within the organization). Both are important.

  2. Does Your CAPA Need A CAPA?

    Conceptually, performing corrective and preventive actions (CAPA) sounds like a very good idea.

  3. The Pros And Cons Of Buying Vs. Building A Quality Management System

    Regulated companies that are looking into either buying or building a quality management system (QMS) generally fall under two categories: the small company (perhaps a startup) that has no QMS at all, or the established company seeking to improve its existing QMS.

  4. Thermally Protective Packaging: Five Essentials Of Gel Refrigerant Design And Specification

    Temperature controlled packaging is used throughout many industries to protect temperature sensitive products. By Anthony Alleva, TCP Reliable, Inc. and Karen K. Greene, Life Packaging Technology LLC

  5. Use Of Historically Collected Ambient Temperature Data In The Creation Of Temperature Profiles

    One of the most continuously undefined yet singularly utmost important variables of temperature controlled shipping is the actual ambient temperature that will be found enroute. By Jason Heberle, CTP, Cold Chain Development Engineer, Cryopak, Inc

  6. 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.

  7. 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.

  8. Is Your Biobank Ready For The Challenge Of Biomarker-Based Research?

    In this whitepaper we review the key drivers impacting “traditional” biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges, we introduce the concept of Next Generation Biobanking and define the attributes an “ideal” Next Generation Biobank would need to drive effective biomarker-based research. Finally we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery. By Mark A Collins Ph.D., BioFortis, Inc.

  9. 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.

  10. Stop Holding Your Logistics Manager Accountable

    As an executive or decision-maker, you should know there’s a good chance that your company is spending too much on small package shipping. By Brandon Staton