New PDA Resource: 2019 Technology Transfer Industry Survey
Results from the PDA survey on Technology Transfer have now been published documenting key highlights and findings from the participant response! This publication which was...
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Building Trust – Engineering to Quality/Validation
Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, risk-based approaches...
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EU & US MRA Fully Operational – What You Need to Know!
Background In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited...
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Understanding cGMPs for Phase 1 Investigational Drugs
Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP). The requirements of the cGMPs are prescribed...
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Release of 2nd Edition ISPE Baseline Guide 5 for C&Q
Intro ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide...
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FDA Approves Emergency IND in Less Than Three Hours
How a CAI agent helped make a difference (more…)
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How to Measure PQS Effectiveness Using the CAPA System
A ICH Q10 Challenge (more…)
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How to Maintain Equipment Readiness During Modified or Idle State
A considerable amount of effort goes into developing an asset maintenance plan that combines all the technical and administrative measures throughout the life cycle of...
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Managing Uncertainty and Maintaining Progress
Imagine the following scenario: The capital project is large, multinational, and complex. It is in the early stages of the project lifecycle, and the schedule...
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Download the Whitepaper: Power of Design Review
Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and...
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