PDA Journal of GMP and Validation in Japan

Regular Article

Practice for CSV of Cloud-Based GxP Business Systems:

Cloud CSV Group, ERES (Electronic Records Electronic Signatures) Commi ...

2016 Volume 18 Issue 2 Pages 25-122
Published: 2016
Released on J-STAGE: December 20, 2016

DOIhttps://doi.org/10.11347/pda.18.25

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It could be worthwhile to make proposals related to practical methods for CSV of cloud-based GxP business systems, given that any guidelines for CSV of those systems have not yet been issued by the Ministry of Health, Labor and Welfare. In this study, we will show development activities, verification activities and a supplier audit, all of which our group experienced, for a SaaS-type electric document management system for GxP businesses, leading to an attempt to share the best practices in CSV of cloud-based GxP business systems. The feasibility of our proposal related to the CSV life-cycle management of cloud-based GxP business systems at the previous PDA Japan Annual meeting will also be discussed in this study.

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Topics Review

LFC Technology for CCIT on Pre-filled Syringes In-Line and the validation approach

Toni Wertli, Marcel Koch, Jaime Cobo

2016 Volume 18 Issue 2 Pages 123-127
Published: 2016
Released on J-STAGE: December 20, 2016

DOIhttps://doi.org/10.11347/pda.18.123

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  The increasing expectations of CCI inspection in any kind of pharmaceutical product has been also observed for pre-filled syringes.
  Beside the single testing stations, a high speed solutuion has been developed and designed.
  A non-destructive deterministic CCI testing method suitable for detection of leaks in pre-filled syringes will be shown as well as their performance and validation approach at high speed conditions.
  Statistics comparing sensitivity, repeatability and separation of pass/fail will be shared as well as a discussion about the validation approach when testing prefilled syringes (PFS) in a deep vacuum decay testing cycle.

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Determination of Oxygen Ingress Through Syringe Packages by Using Laser Headspace Analysis

James Veale, Ken G. Victor

2016 Volume 18 Issue 2 Pages 128-141
Published: 2016
Released on J-STAGE: December 20, 2016

DOIhttps://doi.org/10.11347/pda.18.128

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Syringes and cartridges need to be a barrier to microbial ingress and in some cases (e.g. oxygen sensitive formulations) oxygen ingress. Container Closure Integrity (CCI) is the main measure of a packages ability to maintain stability and sterility over the intended shelf life.
We develop laser headspace analysis for assessing oxygen ingress rates into two types of syringe packages. We measure oxygen ingress to a Luer Tip and Staked Needle syringe package. The syringe packages were prepared in a way that allowed isolated study of different parts of each syringe so that oxygen ingress rates could be determined for each part of the syringe.

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Nondestructive Container Closure Integrity Tests for Prefilled Syringes “High Voltage Leak Detection Method”

Akira YAMANAKA

2016 Volume 18 Issue 2 Pages 142-149
Published: 2016
Released on J-STAGE: December 20, 2016

DOIhttps://doi.org/10.11347/pda.18.142

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This document is to introduce that we have performed Container Closure Integrity Tests for Prefilled Syringes by using High Voltage Leak Detection method as one of several leak inspection approach for closure container product and have succeeded to obtain sufficient inspection performance with test method and result data that can be validated in pharmaceutical production facilities.

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