Prabandh for Pharma and Life Sciences

Specification to release to recall, with the records an auditor will ask for.

For makers of medicines, nutraceuticals, diagnostics and medical products: controlled specifications, release gated by quality control, certificates of analysis, change control, requirements traced to tests, licences and a permanent audit trail.

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Sound familiar?

What pharma and life sciences businesses tell us.

A batch is released from a spreadsheet and an email.

A change is approved on paper and the floor learns later.

Supplier certificates and licences expire without anyone noticing.

A certificate of analysis is rebuilt by hand for every batch.

Requirements and the tests that prove them live in different files.

Built for this industry

What is specific to pharma and life sciences.

Release against the specification
A batch is released only when its results meet the limits.
Traceability both ways
From a customer back to the ingredient lots, and the reverse.
Requirements to tests
Each requirement linked to the test plan and run that verifies it.
Supplier evidence
Audits and certificates with the file and the expiry date.
Corrective action
Nonconformances and deviations run to closure with an owner.

Be aware

A conventional-pharmaceutical pack (dosage-form masters and validation documentation) is planned and not yet released; today the depth is in AYUSH, nutraceutical and similar regulated products. Electronic-record and signature rules such as 21 CFR Part 11, device identification, serialisation and cold-chain monitoring are not included.