Transcript Item 6b - Freeman - MPB update June 2016 for SC18

Ballot Results for 18TR3
Number of
Organizations
Percent of
Total
Number of
Comments
Percent of Total
Operators
4
8%
125
25%
Manufacturers
37
73%
284
58%
Consultants
8
16%
41
8%
API Staff
2
4%
36
7%
Commenting Group
Totals
51
486
About 25% of the comments would require significant rework of the document.
About 20% of the organizations providing comments recommended withdrawing the document.
API Monogram Program Update
• MPB recommended to SC18 to stop work on 18TR3 API
Monogram Program: Definition of a Manufacturer and to provide
the document/comments to MPB for further consideration of
implementing controls on licensed manufacturers to improve the
integrity of the monogram program.
• MPB efforts on definition of manufacturer will focus on:
•
•
•
•
Complete definition of the problems facing the monogram program relative
to facility licensing.
Updating API Q1, A.7 to exclude certain categories of manufacturing from
licensing
Suggesting improvements to API SC18 TG2 updating Q1 for further controls
on outsourced suppliers.
Developing auditing requirements for critical suppliers and suppliers of
processes applied to critical components.
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