Incoming material control
Every active and excipient lot is quarantined, sampled under LAF and tested for identity, assay and impurity profile before it can be dispensed.
Quality Assurance
Quality is not a
department. It is a habit
Independent QA authority, ALCOA+ data integrity, and analytical testing on every incoming material, in-process stage and finished batch.
Quality architecture
The only function that can
stop everything
Quality assurance at RIVANOVA reports to the board, not to production. That single structural decision is what makes the rest credible: a QA officer who rejects a batch is not overruling their own manager, and cannot be pressured by a despatch deadline.
The function covers incoming material testing, in-process control, finished goods release, stability monitoring, deviation and CAPA management, change control, self-inspection and supplier qualification. It holds the retention samples, it owns the audit trails, and it signs — or withholds — every release.
0
Batch-release conformance against specification, rolling 36 months.
0
Product recalls initiated in the company's operating history.
0
Regulatory and customer audits hosted in the last three years.
0
Incoming actives re-tested in-house regardless of supplier certificate.
Analytical laboratory — Quality Control
HPLC · GC · UV-Vis · FTIR · dissolution · stability chambers
Quality systems
Six systems that run continuously
In-process control
Weight variation, hardness, friability, disintegration, fill volume and pH are monitored throughout the run, with automatic rejection where limits are breached.
Stability programme
Real-time and accelerated studies under ICH Zone II and IVb conditions, with photostability per Q1B. Every commercial product carries an ongoing stability commitment.
Deviation & CAPA
Every deviation is logged, investigated to root cause and closed with corrective and preventive actions whose effectiveness is verified before closure.
Change control
No change to a process, specification, supplier or facility proceeds without documented impact assessment and QA approval — including changes that look trivial.
Self-inspection
A cross-functional team audits every department annually against GMP requirements, with findings tracked to closure exactly like a regulatory observation.
Most data integrity findings are not fraud. They are a system that made the honest path harder than the convenient one. We design for the opposite.
Dr. A. Nambiar
Head — Quality Assurance
Data integrity
ALCOA+, enforced by the system
Data integrity is not a training topic here — it is a set of technical controls that make non-compliant behaviour impossible rather than merely prohibited.
- AttributableUnique login credentials on every instrument. No shared accounts, no generic operator IDs.
- Legible & contemporaneousElectronic records captured at the moment of the activity, with system-clock timestamps that operators cannot alter.
- Original & accurateDeletion rights disabled at the application level. A result that exists cannot be made not to exist.
- Complete & consistentAudit trails reviewed by QA before batch release, not retrospectively during an inspection.
- Enduring & availableValidated backup with periodic restoration testing, and retention aligned to shelf life plus one year.
Analytical scope
What we test, and against what
| Test | Applies to | Instrumentation | Reference standard |
|---|---|---|---|
| Assay & related substances | All dosage forms | HPLC with UV / PDA detection | IP · BP · USP monograph |
| Dissolution profile | Tablets, capsules | USP Apparatus I & II | USP <711> |
| Uniformity of dosage units | Tablets, capsules, vials | HPLC · analytical balance | USP <905> |
| Residual solvents | Oral solids, injectables | Headspace GC-FID | ICH Q3C |
| Identification | All raw materials | FTIR · UV-Vis | Pharmacopoeial reference spectra |
| Microbial limits | Oral liquids, topicals, nutrition | Microbiology suite | USP <61> / <62> |
| Sterility & endotoxin | Injectables | Isolator · LAL assay | USP <71> / <85> |
| Water content | Hygroscopic solids, powders | Karl Fischer titration | USP <921> |
| Particulate matter | Injectables | Light obscuration counter | USP <788> |
| Purified water & WFI | Utility systems | TOC · conductivity · bioburden | USP <643> / <645> |
Ask us for the documentation
Certificates of Analysis, validation reports, stability data and site master files are available to qualified partners on request.