👉PHARMACEUTICAL NOTES
👀How many SOPs are required for
equipment?
Operation, Cleaning, Preventive maintenance (or)
Calibration, and Sampling procedure
👀What is the BPCR?
BPCR means Batch Production
Control Record. This was prepared for each intermediate and API and include the
complete information relating to the completion of each step for Batch
production.
👀What is the MPCR? Master production
control record (MPCR)?
MPCR means Master Production
Control Record. It ensure the uniformity from batch to batch, master production
instructions for each intermediate and API are prepared, dated and signed by
one person, immediately checked, dated and signed by a person in the quality
unit.
👀What is critical process parameter?
A process test when it is
essential to maintain a predetermined range in order to reproducible meet the
specification is called critical parameter. These parameters have direct impact
on the quality of the product. So these parameters should be monitored and
controlled to ensure the process get desired quality.
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