ARTICLES BY GRANT MORDUE
The 8-Step Checklist To Write Effective Investigation Reports7/16/2021
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
11 Critical Steps To Manage Solvents During API Manufacturing3/5/2021
Manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This presents a cross-contamination risk that might go undetected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and mitigation options available to API manufacturers.
9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants2/12/2021
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
Managing CMO Quality And cGMP Compliance Capabilities: A Framework11/25/2020
When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.
Generate The Right Input Data For A Quality Management Review System9/21/2020
In this part two in a series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems, we turn our attention to the input data for an effective quality management review.
"Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap9/16/2020
This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.