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Critical quality events-QP




Critical quality events-QP

EU Guidelines for Good Manufacturing Practice for Medicinal Products for
Human and Veterinary Use - Annex 16: Certification by a Qualified Person
and Batch Release

Quality Event: The event occurred during manufacturing / analysis of batch
/ lot or event occurred during the batch / lot is in the distribution system or
as a market feedback which is likely to have potential impact on finished
product

Qualified Person (QP): QP is the person responsible for ensuring that
each individual batch has been manufactured and checked in compliance
with laws in force in the Member State where certification takes place, in
accordance with the requirements of the marketing authorization (MA) and
with Good Manufacturing Practice (GMP)

Periodic Events Notification-
Quality events summary report shall be prepared on quarterly basis
1.    Incidents-
Incidents which have a systemic effect:
· Any validation / qualification failure which have a direct impact on product quality.
· Incidents related to Cleaning validation failure.
· Any other deviations which will have an impact on product quality.


2.    Change Control-
Change control impacting systems:
· HVAC, WFI system, pure steam generation system, Purified water system, process equipment which were not reported as a batch specific event.
· Related to facility changes which have a direct impact on product quality, like
o Changes in Grade A, B or C areas of manufacturing.
o Changes in Grade A, B areas of microbiology.
· Any changes in product specification or validated parameters, which were not reported as batch specific event.

3.    Quarterly EMP/ Water trend summary-
Only excursions to be reported. If there is no excursion during this period, report as “No Out of limit results reported”.

4.    Stability failure/ Critical Market complaint-
In case of stability failure in commercialized products, QP shall be informed on immediate basis for further actions, in line with the technical agreements with customers. However, in periodic events notification, a summary shall be provided.

5.    Adverse report finding-
Any adverse report related to the product quality complaint to be reported


6.    Any regulatory actions-

To brief about any regulatory actions like, critical observations, warning letter issued to the facility, import alert raised

7.    Media fill positives-
Notification timeline shall be as defined in the relevant technical or quality agreements
8.    Sterility test failure-
Any sterility test failure related to that particular line in this period which was not reported as batch specific event.

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