You may not realize this but the activity of filing is still regarded as a critical processing area where the products are exposed and open to risk of cross-contamination. Secondary packager may not be involved in the manufacture of products, however, they are still required to validate their HVAC system for the filling process.
Water used for final rinsing of contact parts must also be of Purified water grade, BP or USP and related equipment be qualified.
Without compliance to the above, you may only be licensed for the packaging of herbal/traditional products and health supplements.
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AJ.
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En.azman,
ReplyDeletestatement bove explained about a critical processing area means the direct contact area with product, so how about non-critical processing area, means the area that indirectly with product..
tq
regards,
shazlina
For areas where products are not exposed, there is no critical processes that may adversely affect quality., eg. labeling and cartoning. Risks presented only for coding/labeling error and product mix-ups. So, such activities are considered non-critical and need not require any qualification. I'll be very shocked if the authority require qualification be done...!
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