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Louder Than Words: The Key to Effective Communication

By John Krawczyk, November 26, 2019

It is a well-established maxim that "Good communication is the key to successful projects." Clear, concise, specific communication is the goal, and this applies to business as well as day-to-day life. The trouble is following through on it.

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Project Meetings Playbook: Your Map to Meeting Nirvana

By Melissa Austin, October 22, 2019

Project Team Meetings are rarely identified as a risk event for a project’s success. Yet, non-productivity during these collaboration sessions is highly probable and can be very costly.

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New PDA Resource: 2019 Technology Transfer Industry Survey

By Beth Haas, September 9, 2019

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 co-authored by one of CAI's principal consultants, Beth Haas, can be found in the PDA Bookstore.  Learn more about Beth below.

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Building Trust – Engineering to Quality/Validation

By Chip Bennett, September 6, 2019

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 rely heavily on Engineering Subject Matter Experts (SMEs) and the application of Good Engineering Practices (GEPs) as an Engineering Quality Process to underpin C&Q.

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EU & US MRA Fully Operational - What You Need to Know!

By John Henchion, July 25, 2019

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 reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.

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Understanding cGMPs for Phase 1 Investigational Drugs

By Dan Carpentio, July 18, 2019

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 in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211).  But there is a unique situation in which the requirements of 21 CFR 211 in the manufacture of a drug are exempt.  That is for the manufacture of Phase 1 investigational drugs.

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Release of 2nd Edition ISPE Baseline Guide 5 for Commissioning and Qualification

By Steve Wisniewski, July 16, 2019

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 revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a compliant, efficient, and cost-effective approach.  The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment.  It supersedes the 2001 publication and the two 2011 Guides covering Quality Risk Management/ASTM E2500 based approaches.

The new Guide provides an improved QRM C&Q process flow and recommended implementation practices with practical examples taken from the industry.

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FDA Approves Emergency IND in Less Than Three Hours

By Cheryl Bondurant, June 27, 2019

How a CAI agent helped make a difference

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How to Measure PQS Effectiveness Using the CAPA System

By John Henchion, June 25, 2019

A ICH Q10 Challenge

 

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Inactive Maintenance: How to Maintain Equipment Readiness During Modified or Idle State

By Nick Armstrong, June 20, 2019

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 a piece of equipment aiming to preserve as well as restore its readiness so it can perform its required function. Often, the premise of these plans is that the asset is operating and mostly in a steady state. Strategies based on this premise is an incomplete approach that even the best companies fall victim to with unexpected, and at times, tragic consequences. Engineers and maintenance leaders need to ask themselves what special considerations to address when equipment is in an idle state for an extended period or operating in a reduced or modified state (such as would be experienced following new construction) before being placed into production.

 

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How to Understand ASTM E2500