White Papers

  1. Validation, Verification And Monitoring For Product Inspection Equipment
    3/16/2017

    This white paper is primarily aimed at Quality Managers and Production Managers in food manufacturing organizations, although manufacturers in other industries may also find it relevant. It gives guidance on the essential processes of validation, verification, and routine performance monitoring for in-line product inspection equipment.

  2. Integrate Pharmaceutical Development For Commercialization Of Novel Therapeutics
    3/13/2017

    Cost reduction initiatives in R&D organizations frequently focus on the potential benefits of process improvements such as enhanced monitoring and improved QC of raw materials but often overlook the impact of better data management. Those that do typically focus on achieving efficiency gains by transitioning from paper to electronic systems but while such a transition has been demonstrated to save time3, efficiency gains are only beneficial if any time saved is used productively.

  3. How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions
    3/2/2017

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

  4. Security Of Pharmaceuticals: A Comparison Of EU And US Standards
    2/27/2017

    With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain.

  5. Optimize Your Critical Cleaning Process And Ensure Results
    2/2/2017

    Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

  6. Why Medical Device Manufacturers Should Get Cleaning Validation Support From The Supplier
    2/2/2017

    Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money when establishing either cleaning validation or cleaning verification processes. This white paper outlines the basics of cleaning validation and how the cleaner manufacturer can help simplify and speed up the process, as well as support ongoing maintenance of the validated or verified state.

  7. Why Pharmaceutical Manufacturers Should Get Cleaning Validation Support From The Supplier
    2/2/2017

    Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

  8. Streamlining Change Control In Today’s Complex Life Sciences Organizations
    1/11/2017

    Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.

  9. How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management
    1/11/2017

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  10. For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research
    1/11/2017

    “Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.