FDA White Papers & Case Studies

  1. Sterile Drug Products Produced By Aseptic Processing — Current Good Manufacturing Practice 7/28/2011

    This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. By PharmaSystems, Inc.

  2. GlaxoSmithKline Ltd., Cork, Ireland 6/29/2011
    GlaxoSmithKline is one of the world’s leading researchbased pharmaceutical and healthcare companies with a share of approximately 5% of the world’s pharmaceutical market. By Beamex
  3. AstraZeneca Ab, Sweden 6/29/2011
    Sweden Operations is AstraZeneca’s largest production and product support unit, and the majority of production facilities are located in Södertälje. The largest tablet factory in the world is located here. By Beamex
  4. White Paper: Pharmaceutical Sterility Testing — Essential Things You Must Know 6/7/2011

    Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. An understanding of sterility testing is beneficial in terms of designing a validation process. By Steven G. Richter, Ph.D

  5. White Paper: Designing Biopharma And Pharmaceutical Cleanrooms 5/23/2011
    Richard Paley of Bovis Lend Lease takes a look at the key issues in the design, specification and selection of cleanrooms, considering the impact on the final build solution and comparing different classes and finishes to show the advantages or disadvantages of each. By Bovis Lend Lease
  6. White Paper: Utilizing InfoBatch To Generate Clean-In-Place (CIP) Reports 4/22/2011
    Many sterile manufacturing facilities find it difficult to manage Clean-in-Place (CIP) reports and are searching for a solution. InfoBatch is a flexible electronic batch reporting application that can be configured to create and maintain CIP reports for manufacturing facilities. By Informetric Systems Inc.
  7. Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines

    Although metal detection has been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants for decades in the pharmaceutical industry, it has not been widespread.

  8. DEA Imposes Extra Layer Of Regulations On Manufacturers Of FDA-Approved Prescription Drugs To Alleviate Pain

    Because prescription pain medications too often have been diverted into the illegal drug trade, development, manufacturing, and distribution are much more complicated for these drugs than for other prescription therapeutics. To produce prescription pain medications in the U.S., manufacturing facilities must abide by the rules and regulations of two federal agencies: the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA), an arm of the U.S. Department of Justice that is charged with enforcing the Comprehensive Drug Abuse Prevention and Control Act, better known as the Controlled Substances Act (CSA).