At Embio, quality is a state of the mind and the
people. It is this passion for quality that has made
us a force to reckon with in the industry.
Manufacturing is strictly as per cGMP - current
Good Manufacturing Practices.
A designated in-house team of QC and QA ensures that
the standards are met and Standard Operating Procedures
(SOP's) are meticulously followed at each and every
step of the manufacturing process.
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Embio a well equipped QC lab continuously monitors
Raw Material / Intermediates at each and every stage.
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Procurement of raw material is done after strict vendor
qualification procedures. Stringent quality control
measures are enforced before acceptance of the raw material.
All instruments are calibrated according to
a pre-determined calibration schedule & validated
on a regular basis.
Special
care is taken to maintain the quality of water,
which meets with the USP requirements. The demineralised
water is prepared by passing it through suitable
resins, UV lamps & micron filters. Microbiological
limits are set & are frequently monitored.
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The documentation procedures are in line with
the latest cGMP requirements. Master documents
are maintained for comprehensive SOP's, QC specifications
& test methods, Batch Process Records (BPR's) &
validation protocols.
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