PDA Journal of Pharmaceutical Science and Technology

PDA Journal of Pharmaceutical Science and Technology
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Abstract The development of mass spectrometry-based leak detection for pharmaceutical container integrity was undertaken to provide an alternative to microbial challenge testing. Standard 10-mL vials were modified to contain pinholes (0.5 to 10 microns) by affixing micropipettes with epoxy into 2-mm vial side wall holes. The absolute leak rate was...

Background During the commercial manufacturing phase of the product lifecycle, specific elements of the PQS are used to identify and manage PACs. Per ICH Q10, these include management responsibilities, the four quality system elements—process performance and product quality monitoring (PPPQM), corrective and preventive action (CAPA), change...

As Congress currently struggles with legislation around Obamacare, I had the privilege of speaking with John Sculley, legendary marketing genius and former CEO of Pepsi and Apple. “The healthcare industry is the only technology-driven industry where we spend more each year and get less for our money. I intend to do something about it.” With those...

Abstract This is the third in a series of seven articles discussing the Recall Root Cause Research project conducted by the Division of Manufacturing and Product Quality, Center for Drug Evaluation and Research. This paper reviews the regulatory and scientific impact of a common and recurring opportunistic pathogen, Burkholderia cepacia. B. cepacia...

PDA members' subscription to the PDA Journal includes free access to the current and previous volume years for the duration of their membership. Access to the archives must be purchased on a pay-per-view basis. Nonmembers must purchase access on a pay-per-view basis, or can sign up as a PDA Member for access to the current and past volume years for...

Abstract Environmental monitoring and aseptic process simulations represent an integral part of the microbiological quality control system of sterile pharmaceutical products manufacturing operations. However, guidance documents and manufacturers practices differ regarding recommendations for incubation time and incubation temperature, and,...

CEX Background At the previous viral clearance symposium, insights into the general mechanism of viral clearance by cation exchange chromatography (CEX) were shared by Amgen and Novartis (1). Amgen presented data from multiple monoclonal antibody (mAb) products that consistently revealed ≥4 log10 murine leukemia virus (MuLV) clearance when run at a...

PDA members' subscription to the PDA Journal includes free access to the current and previous volume years for the duration of their membership. Access to the archives must be purchased on a pay-per-view basis. Nonmembers must purchase access on a pay-per-view basis, or can sign up as a PDA Member for access to the current and past volume years for...

PDA members' subscription to the PDA Journal includes free access to the current and previous volume years for the duration of their membership. Access to the archives must be purchased on a pay-per-view basis. Nonmembers must purchase access on a pay-per-view basis, or can sign up as a PDA Member for access to the current and past volume years for...

Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, and Anders Vinther