Six gates betweenblending and release.
Any one of them can stop a batch. None can be skipped to protect a delivery date.
- 1
Raw material
Identity and assay of every API and excipient on receipt.
- 2
Blend uniformity
Sampled across the blender, not just from the top.
- 3
Weight and hardness
Checked at fixed intervals throughout compression.
- 4
Disintegration
Release profile verified against the specification.
- 5
Microbiology
Bioburden, and sterility testing for injectables.
- 6
QA release
One named signature carries the batch to market.
Certified to the standards buyers ask for.
Rolsmed works to WHO-GMP and ISO 9001:2015 and holds an FSSAI licence for its nutraceutical range.
How to verify us.
Request
Send the scope of your audit and the standards you work to.
Document review
The site master file and the quality manual, in advance.
Site visit
Production, warehouse, QC laboratory and retained samples.
Written report
Findings answered in writing with a dated corrective plan.
Questions the record cannot answer?
Ask quality directly. A named person replies.
Ask quality