Have you established in-process hold times?
A company recently received this 483 observation:
…..Deviations from production time limits are not documented.
Specifically, excursions in hold time are not investigated, trended or otherwise evaluated for product impact. There have been multiple hold time excursions for multiple drug products. Your firm’s Annual Product Quality Review was silent regarding manufacturing hold time excursions. Your firm’s Quality Manager qualified this practice by referencing an SOP which states “ln case during commercial manufacturing if the product-exceeds the established hold time period at any stage, sample shall be collected and shall be submitted to Quality Control for re-testing.”
For more observations pertaining to Manufacturing Controls see Issue 1013 available today. It features Packaging and Labeling observations on our rotating topic page 3 as well as Laboratory Controls and Medical Device Manufacturing Controls.
Also out today, our Quarterly Special Report. This is a comprehensive 6 page report on observations pertaining to 21 CFR 211 Subpart F and 21 CFR 820 Subpart G – Production and Process Controls. There are observations on deviations, sampling and testing of in-process materials and drug products, control of microbiological contamination and process validations.