Biomedical Engineering Reference
In-Depth Information
Table 3.6
Change management documentation
1. Description of
changes
All changes listed above were described. These included
the facility changes, equipment changes, calibration
procedure change, and weighing procedure change.
2. Reason for
change
These changes were due to observations and testing that
suggested that product potency seemed to have
excessive variation. Evaluation of current facilities and
procedures indicated that improvements could be quickly
and easily accomplished. The importance of the weighing
procedure in determination of potency of commercial
product was noted.
3. Risk analysis
and evaluation
The formalized risk analysis of the potency determination
process - including weighing procedure and associated
activities - was documented. The risk analysis document
identifi ed specifi c activities to lessen identifi ed risks.
4. Change
management
plan
Requirements and considerations to implement the
described changes included:
Agreement with standards and internal policies:
These included the review of FDA and internal
requirements.
Procedure changes: Changes to two operational
SOPs were identifi ed: 1) Calibration procedure; and
2) Sample weighing procedure.
Regulatory documents affected: There were no
regulatory documents affected by this change.
Calibration procedures and weighing procedures are
not fi led as regulatory documents.
Testing requirements: The comparative testing and
acceptance requirements for testing were specifi ed.
The treatment of statistical data was described.
Other requirements: Training of calibration personnel
and laboratory analysts on respective new SOPs was
described. In addition, training of laboratory analysts
was enhanced to include a skill demonstration
assessment (SDA) using the revised procedure
described above.
Ongoing monitoring: Laboratory management would
conduct timely ongoing recording of product potency
data to continually monitor and confi rm the effi cacy
of the above changes.
Communication to affected areas: Areas affected by
the changes described and associated work were
identifi ed. This included responsible CAPA
management who initiated the original investigation
addressing high potency variation. Laboratory facility
engineering drawings were also updated to refl ect
changes.
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