Quality & compliance

Quality is not a final check. It is the operating system.

Walter’s quality approach connects controlled infrastructure, trained people, documented processes, in-process controls, laboratory testing and QA-led release.

01

WHO-GMP

WHO-GMP certification is presented only for the facility, dosage-form scope and validity stated in the underlying certificate.

02

WHO-GDP compliant

Distribution practices are presented as a compliance statement, not as an Indian GDP certification.

03

GMP · Revised Schedule M

The Unit III GMP certificate expressly references revised Schedule M; reliance remains limited to its stated scope.

04

GLP · Schedule L-1

Unit III testing facilities are certified against Schedule L-1 for the stated and time-limited scope.

05

FSSAI

Food-safety licences support the manufacturing and wholesale activities stated in each certificate.

06

Controlled verification

Facility, product, market and validity are checked before a credential is relied upon.

Quality management

Controls that travel with the batch.

Quality-control team conducting a daily briefing around documented laboratory principles
Quality cultureTraining & daily briefing

Select any control to see how it is applied and documented.

LabTrust™

Testing capability built close to manufacturing.

In-house quality-control environments help manage sampling, timelines, investigations, documentation and release coordination.

UV spectroscopy zone in Walter Healthcare's quality-control laboratory
01 · Analytical environmentUV spectroscopy zone

A connected laboratory setting for analytical and wet-work workflows.

Analyst using an HPLC testing station in the quality-control laboratory
02 · ChromatographyHPLC testing station
HPLC workstation in Walter Healthcare's quality-control laboratory
03 · Data captureHPLC workstation
Loss-on-drying and oven testing area in the quality-control laboratory
04 · Physical testingLOD & oven testing
Wet analysis workbench in Walter Healthcare's quality-control laboratory
05 · Wet analysisBench-scale analysis
Volumetric titration setup in the quality-control laboratory
06 · Volumetric analysisTitration setup

Representative Unit III laboratory imagery · 2025. Equipment availability and testing scope are confirmed during technical review.

Analytical testing

  • HPLC and related chromatographic techniques
  • UV-visible and FT-IR spectroscopy
  • pH, titration and water analysis
  • Dissolution, disintegration and friability
  • Moisture and loss-on-drying methods

Microbiology & biological

  • Sterility and bacterial endotoxin testing
  • Environmental monitoring
  • Microbial-limit testing
  • Culture-media growth promotion
  • Cleanroom support activities

Physical & stability

  • Hardness and weight variation
  • Viscosity, density and refractive index
  • Leak and container-closure checks
  • Temperature and humidity stability conditions
  • Monitored chamber programmes

Due diligence

Evidence before adjectives.

Certificate status, scope, validity and facility applicability should be verified during technical and commercial due diligence. Walter can provide relevant controlled documents to qualified prospects where appropriate.

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