Biomedical Engineering Reference
In-Depth Information
• Batch manufacturing
record with requirements
to document:
manufacturer,
manufacturer's unique lot
number and
manufacturer's catalog
number and expiry date
for each material used in
the batch
14.
Lack of
adequately
controlled
procedures
Failure of any of
the above-
mentioned
controls
Unsafe product
Risk mitigated/
acceptable
YES
• Develop a quality system
with a list of SOPs that
must be in place before
start of GMP production
• Develop detailed batch
manufacturing instructions
and quality control
records to capture
activities (e.g.,
manufacturing operations,
in-process sampling) as
they are performed and
record any
changes/deviations
• Train, coach, supervise,
and test personnel
(
continued
)
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