ARTICLES BY GRANT MORDUE

• Cleaning Verification & Validation Of Multipurpose API Plants: 9 Rules To Follow

  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.