ARTICLES BY GRANT MORDUE
11 Critical Steps To Manage Solvents During API Manufacturing
To reduce costs and provide flexibility, manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of active pharmaceutical ingredients (APIs) and associated intermediates. This presents a risk of cross-contamination that might not be detected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and 11 mitigation options available to API manufacturers.
9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants
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 Framework
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 System
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 Gap
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.