Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint, and not a compendial approach as espoused in the US Pharmacopoeia’s (USP) Chapter 790 method.
 
Stephen Langille, senior microbiology consultant with ValSource, Inc, and a former microbiologist with the agency, spoke on the draft guidance at the 46^th annual International GMP conference in Athens, GA on 7 March. The meeting, which is co-sponsored by the University of Georgia College of Pharmacy and FDA, was held virtually this year.
 
The draft guidance was issued in December 2021. (RELATED: FDA addresses establishment of inspection programs for injectables, Regulatory Focus 16 December 2021)
 
Drugmakers and pharmaceutical industry groups urged FDA to align its classification categories for visible particles with the US Pharmacopoeia’s (USP) Chapter 1790 in comments on the draft guidance. (RELATED: Industry wants FDA to align visible particle classifications and inspections with USP, Regulatory Focus, 16 February 2022). 
 
Langille addressed why this is unlikely. He said that FDA takes a different approach to visible particle control than USP and that the guideline is “a little more thorough about inspections. FDA has to ensure that GMPs are being employed in the manufacturing process.”
 
Why guidance does not incorporate EU Annex 1
 
Langille also explained why the guidance does not incorporate language on the proposed contamination control strategy in the upcoming revision of the EU’s GMP Annex 1 on GMPs for sterile drug products. The annex is expected to be released by the EU in collaboration with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization. This complaint also surfaced in industry’s response to FDA on its draft guidance.
 
Langille responded that Annex 1 principles regarding the contamination control strategy are already “built into” GMP principles.
 
Georgia GMP conference