QCS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 99

SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:
2. QC laboratory manager must fill in the “comment” section including an impact analysis,
further action, and propose the disposition of affected batches.
3. QC laboratory manager should forward the original form to the QA department for final
approval.
18.5.5.3 Qa director
The decision for the rejection or the release of the product impacted by the OOS result is determined
by the QA director.
18.5.5.4 regulatory affairs manager/director
Where applicable, within 3 working days, the director—regulatory affairs must inform the related
regulatory agencies and customers of the failing marketed batches and collaborate with them in
disposition of these batches from the marketplace.
18.6 attachments
• OOS Investigation: Form 01
• OOS Investigation Process Flow Chart: Attachment I
18.7 reason for revision
First time issued for the ABC Pharmaceutical Company.