Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-028.00 Effective date: mm/dd/yyyy
Approved by:
47.3.1.2
unusual incidence or event reporting
1. All those citation which cannot be categorized as a violation of cGMP (refer to GMP SOP
QAS-023) are unintentional and fall under the group of “nonconformance to normal prac-
tices” or “out of the usual run of things” will also be reported on the ICR.
2. The ICR will be raised by manufacturing, packaging, quality assurance, and quality con-
trol in case of an event unusual to normal practice.
3. Some examples include
a.
Breakdown of machine during processing
b.
Batch/lot complying after double sampling or resampling, and so on
c.
Pest control
i. If the pest is observed in the area by any employee, the information should be
given to the supervisor.
ii. The supervisor of the area should stop the operation (manufacturing and/or pack-
aging). The QAIs are also authorized to stop the line if any pest is observed in the
area (separate SOP for corrective/preventive measures in case of pest observance
in aseptic core).
iii. The product shall be protected as per the general production system.
iv. The area shall be locally treated to spot the insect and remove it.
v. The area must be physically inspected for the absence of pest by the area supervi-
sor and the QAI.
vi. The area will be given line clearance.
vii. The QAI will raise the ICR (refer to Attachment I) and will document the correc-
tive action.
viii. The product manufactured or packed before the incident must be inspected 100%
before
process
continuation
by
the
production/packaging
supervisor
as
applicable.
47.4 documentation
• ICR (Attachment I)
• Monthly trend report format (Attachment II)
47.5 reason for revision
First time issued for the ABC Pharmaceutical Company.
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