QAS-028 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 402

SOP No. QAS-028.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Incidence Citation Report
47.1 PurPose
The purpose of this SOP is to describe the procedure and events to raise an incident report and to
initiate the corrective actions in the event of cGMP violations and unusual events.
47.2 resPonsibility
It is the responsibility of all employees to follow the procedure of generating incidence citation
report (ICR) and take corrective actions. The area supervisor and the manager will be responsible
for completing the corrective action in case of an incidence reporting (where required). The QA and
manufacturing directors will be responsible for the SOP compliance.
47.3 Procedure
1. ICR (Attachment I) will be raised in cases where an unusual event or cGMP violation and
observation has been made by an employee, analyst, inspector, or others.
2. ICR will be forwarded to the QA manager for logging the incidence report.
3. Separate registers will be maintained for logging, registering, and assigning the ICR in a
sequential number.
4. The ICR will be marked back to the concerned department for following up and reporting
of corrective actions completion.
5. The completed ICR will be returned to the QA manager to be signed off by the QA director
for close-out and filing for reference in a separate folder.
47.3.1 c gmP v iolation
1. In the event of cGMP violations, the QAI will raise the ICR and corrective action will be
taken on spot before further continuation of work.
2. The concerned manager will be responsible for the implementation of the suggested cor-
rective action and execution of the preventive measure/s which may include but are not
limited to retraining of the identified personnel, disciplinary action including issuance of
warning letter, verbal reprimand, transfer, or even termination if required.
The corrective and preventive measure will be prescribed individually depending upon
the causes of the incidence and severity of the citation, explanation of the personnel and
supervisor level involved, recurrence, and so on.
3. Besides, QA will also conduct monthly trending of the ICR of the plant to keep the man-
agement informed and initiate necessary actions (refer to Attachment II).
47.3.1.1 classification of incidence citation
Critical: An incidence that, by judgment, experience, and situation indicate if happens, would
cause an unsafe condition in the product or may prevent performance/functionality of the
product.
Major: An incidence that may result in defect/s in the product reducing the usability of the
product.
Minor: An incidence that, indicated by experience, situation, and judgment, may not result in
a product with reduced usability but is a departure from established practices or
standards.