Quality Assurance

Our Quality Standards

Quality is not a department at Chemist India — it is a culture. Every person, process, and product is held to the same rigorous standard.

Quality Control Process

Six-Stage Quality Assurance

From supplier selection to final dispatch, every step is controlled, documented, and auditable.

01

Supplier Qualification

Every new supplier undergoes a rigorous audit process including GMP certification review, facility inspection reports, and regulatory history assessment before we accept a single sample.

02

Incoming Inspection

Each batch received is quarantined and sampled. Identification tests (IR, UV) are conducted on every batch. Full quantitative analysis is performed on a risk-based frequency.

03

Analytical Testing

Our in-house laboratory is equipped with HPLC, GC, KF moisture analyzer, dissolution apparatus, melting point instruments, and ICP-OES for elemental impurity testing.

04

Microbial Testing

For APIs, excipients, herbal extracts, and food chemicals, microbial limits testing (Total Aerobic Count, Yeast & Mould, E.coli, Salmonella) is performed per USP/BP/EP requirements.

05

Documentation Review

Our QA team reviews CoA, MSDS, DMF references, regulatory filings, and batch manufacturing records before approving any product for supply.

06

Release & Dispatch

Only products that meet all specification criteria and have complete documentation are released for dispatch. Each shipment includes CoA, MSDS, and packing list.

Certifications & Compliance

Internationally Recognised Credentials

GMP Certified

Schedule M (India)

Good Manufacturing Practices compliance for pharmaceutical products.

ISO 9001:2015

Bureau Veritas

Quality Management System certified by internationally recognised body.

WHO-GMP

World Health Organization

WHO Good Manufacturing Practices for selected APIs and excipients.

FSMA Compliant

US FDA

Food Safety Modernization Act compliance for food-grade chemicals.

DMF Filed

USFDA / MHRA

Drug Master Files filed with US FDA and UK MHRA for key APIs.

CEP / COS

EDQM

Certificates of Suitability from EDQM for European market APIs.

REACH Compliant

ECHA

European Chemicals Agency registration and compliance documentation.

COPP

CDSCO India

Certificate of Pharmaceutical Product for export registration support.