ECA comments on FDA Guideline on Visual Inspection

The text is to some extend contradictory. It starts with referencing USP General Chapter <1> and its requirement to follow USP General Chapter <790> to conclude that following USP General Chapter <790> alone is not sufficient to point out again to USP General Chapter <1> and its requirements that needs to be taken into consideration.

This twisted argumentation should be replaced by a much shorter explanation that FDA expects both General Chapter should be followed, including the request for a risk-based definition for product specific standards in production and in testing

A revision of Annex 1 (Manufacture of Sterile Medicinal Products) of the PIC/S and EU GMP Guides has been prepared in co-operation with the European Medicines Agency (EMA), WHO and PIC/S in order to maintain global alignment of standards.
The last targeted stakeholder consultation has ended and the final version is expected to be published within the next months.
FDA, being a member of PIC/S was fully included in the consultation process.
It is irritating that the draft FDA Guideline does not at all include any of the adopted wording and considerations laid down in the Annex to implement a Contamination Control Strategy intended not only to control and limit microorganisms and pyrogens but also particles, based on current product and process understanding. The Annex is very descriptive in its requirements for such a control strategy.

In addition, sections 8.30 and 8.31 are providing what must be considered additional GMP considerations for the visual inspection process.

It would be more than highly appreciated if FDA as a PIC/S member would align any new Guideline with existing or nascent PIC/S guidance documents.

This goes back to J. Knapp, H. Kushner (Generalized Methodology For Evaluation of Parenteral Inspection Procedures, PDA J Pharm Sci and Tech, 1980, 34, p. 14-61) with the focus on particle detection. Correct number: not more than 25% defects...once there are other "obvious" defects within the test set the percent can be higher as the 10-20% are only for the focus of particles within units. 

A better wording would be:
Typically, the percentage of defective units in a test set should not exceed 10-20 (25 percent !! instead of 10-20%) percent, and the test set quantities should be sufficient to provide an adequate degree of confidence in the test results, once only particulate defects (and non-defect units) are within the test set.