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...
Read MoreRelease 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...
Read MoreFDA Approves Emergency IND in Less Than Three Hours
How a CAI agent helped make a difference (more…)
Read MoreHow to Measure PQS Effectiveness Using the CAPA System
A ICH Q10 Challenge (more…)
Read MoreHow 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...
Read MoreManaging 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...
Read MoreDownload 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...
Read MoreC&Q Benchmarking: Process and State of the Industry
Risk-based approaches to commissioning and qualification (C&Q) is a common standard for site and project plans. What does that mean and why is there so...
Read MoreWhitepaper: Strong Project Controls are Critical to Your Success
Here's an excerpt from this whitepaper: "The hallmark of a high performing organization is the cultivation, use, and continuous improvement of their processes used to...
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