International
Quality Standards
Every medicine Laborate manufactures meets the highest international quality standards — from WHO GMP and USFDA approval to NABL-accredited laboratory systems — ensuring safety and efficacy for patients in 40+ countries.
- 0 Years of Regulated Manufacturing
- 0 QA / QC Professionals
- 0 GMP-Certified Facilities
- 0 Approved Export Markets
- 0 QC Tests Conducted Annually
Quality is not a department.
It is a discipline.
At Laborate, quality is embedded at every stage of pharmaceutical development and manufacturing — from the selection of raw materials to the release of the finished product. Our quality management system is built on scientific rigor, regulatory transparency, and patient-first thinking.
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Patient Safety First
Every quality decision is evaluated through one lens — what is safest for the patient. Efficacy and safety data govern every batch disposition choice.
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Regulatory Compliance
We operate within and beyond the requirements of WHO GMP, USFDA, Schedule M, and applicable pharmacopoeial standards — with zero compromise on compliance obligations.
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Continuous Improvement
Our CAPA and deviation management systems drive systematic improvement. Every non-conformance is an opportunity to strengthen processes and prevent recurrence.
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Science-Based Decisions
Quality decisions at Laborate are grounded in validated analytical data, statistically sound sampling plans, and pharmacopoeial methods — not intuition.
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Quality Culture
Quality responsibility extends across every function — from production operators to senior leadership. Our GMP training and awareness programmes ensure compliance is owned by all.
A complete QMS across every function
Our ISO 9001:2015 and GMP-aligned quality management system covers ten interdependent quality functions, each with documented procedures, responsible officers, and regular review cycles.
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Quality Assurance
GMP compliance oversight, batch disposition authority, system audits, and QA officer deployment across all production lines.
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Quality Control
Full analytical testing of raw materials, in-process samples, and finished products against approved pharmacopoeial and in-house specifications.
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Documentation
Controlled SOPs, batch manufacturing records, analytical worksheets, and audit-ready document archives maintained under a validated DMS.
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CAPA Management
Structured corrective and preventive action process — root cause analysis, action assignment, effectiveness verification, and regulatory reporting where required.
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Deviation Management
Systematic identification, classification (critical/major/minor), investigation, and controlled closure of all process deviations within defined timelines.
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Change Control
All process, material, equipment, and documentation changes follow a risk-classified change control procedure with impact assessment and regulatory notification.
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Internal Audits
Comprehensive self-inspection programme — scheduled and unannounced — covering all GMP areas, with findings tracked to closure through the CAPA system.
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Training & Qualification
Role-based GMP training curricula, annual competency assessment, qualification records for all operators and analysts, with training effectiveness reviews.
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Process Validation
Three-stage process validation lifecycle (Stage 1: Design; Stage 2: Qualification; Stage 3: Continued Verification) per ICH Q10 and FDA Process Validation Guidance.
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Risk Management
ICH Q9-compliant quality risk management — FMEA, fault-tree analysis, and product risk registers reviewed at each annual product review cycle.
NABL-Accredited. ICH-Compliant. Always Ready.
Our quality control and analytical laboratory network spans five manufacturing sites, with the flagship analytical campus at Panipat holding NABL accreditation under ISO/IEC 17025:2017 — the international benchmark for testing laboratory competence.
Each dedicated laboratory operates under validated environmental conditions, with calibrated instruments, qualified analysts, and methods validated per ICH Q2(R1). Laboratory data is captured in a validated LIMS ensuring data integrity and full audit traceability.
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Chemical QC Laboratory
NABL ISO/IEC 17025:2017Full chemical analysis of raw materials, intermediates, and finished products. Wet chemistry and instrumental methods under validated conditions.
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Microbiological Laboratory
ISO Class 5 CleanroomSterility testing, bioburden determination, LAL endotoxin testing, environmental monitoring, and microbiological limit testing per USP/BP/IP.
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Chromatography Laboratory
ICH Q2(R1) Validated MethodsHPLC, UPLC, GC, and GC-MS systems dedicated to purity, assay, impurity profiling, and residual solvent analysis with certified reference standards.
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Stability Testing Laboratory
ICH Q1A / Q1B CompliantDedicated stability chambers across all ICH zones including Zone IVb (40°C/75% RH) for tropical market registrations. Both real-time and accelerated studies.
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In-Process QA (IPQA)
On-Floor QA OfficersDedicated IPQA officers stationed on every production line for real-time in-process testing, line clearance verification, and immediate deviation escalation.
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R&D Analytical Support
Method Development & TransferMethod development, optimisation, and technology transfer services for new product introductions and CDMO client formulations.
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Instrument Analytical Lab
Centralised Advanced InstrumentsCentral hub for capital-intensive analytical equipment including FTIR, ICP-MS, TOC Analyser, particle size analysers, and UV-Vis spectrophotometers.
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Environmental Monitoring
Cleanroom & Utility SystemsScheduled and continuous monitoring of cleanroom air quality (viable and non-viable particles), HVAC integrity, compressed air, and purified water systems.
State-of-the-art analytical instrumentation
Our validated instrument park covers every analytical requirement from raw material identification to elemental impurity profiling — aligned with ICH Q3D, USP <232>/<233>, and global pharmacopoeial requirements.
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HPLC / UPLC
High-Performance Liquid Chromatography
Assay, purity, and impurity determination for active pharmaceutical ingredients and finished dosage forms per validated pharmacopoeial and in-house methods.
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GC / GC-MS
Gas Chromatography & Mass Spectrometry
Residual solvent testing per ICH Q3C, volatile impurity identification, and confirmatory identity testing for complex API raw materials.
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FTIR
Fourier Transform Infrared Spectroscopy
Rapid and non-destructive raw material identification and verification of excipients against certified reference spectra and pharmacopoeial IR libraries.
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UV-Vis
UV-Vis Spectrophotometer
Assay, dissolution quantification, and content uniformity analysis across UV and visible ranges. Used for rapid QC testing of liquid orals and dissolution media.
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Dissolution
Automated Dissolution Testing
6- and 8-vessel automated dissolution apparatus with online UV and HPLC coupling for real-time dissolution profile generation. USP Apparatus I, II, IV.
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PSA
Particle Size Analyser
Laser diffraction-based particle size distribution analysis for API and excipient characterisation — critical for solid dosage form performance and content uniformity.
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TOC
Total Organic Carbon Analyser
Water system quality monitoring (purified water, WFI) and cleaning validation acceptance limit verification per USP <643> and EMA guidance.
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ICP-MS
Elemental Impurity Analysis
Inductively coupled plasma-mass spectrometry for elemental impurity profiling of drug substances and finished products per ICH Q3D and USP <232>/<233>.
Comprehensive validation across all critical systems
Every process, method, equipment unit, and computerised system at Laborate operates under a formal validation protocol. Validation ensures consistency, reproducibility, and compliance before any system enters production use.
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Process Validation
Full 3-stage lifecycle approach per FDA Process Validation Guidance 2011 and ICH Q10 — design, qualification, and continued process verification.
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Cleaning Validation
Swab and rinse sampling protocols for product changeover, with HBEL-based acceptance limits per EMA guidance and ASTM E3106-18.
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Analytical Method Validation
All test methods validated per ICH Q2(R1) — specificity, linearity, accuracy, precision, range, detection and quantification limits — before product release.
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Equipment Qualification
Design, Installation, Operational, and Performance Qualification (DQ/IQ/OQ/PQ) for all GMP-critical equipment, with documented requalification cycles.
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Computer System Validation
All GxP-critical computer systems validated per 21 CFR Part 11 / EU Annex 11 with electronic audit trails, user access management, and periodic review.
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Stability Studies
ICH Q1A(R2) and Q1B compliant real-time and accelerated stability studies across all ICH climatic zones, supporting shelf-life claims for global registrations.
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Packaging Validation
Primary and secondary packaging integrity validation — seal strength, leak testing, and Alu-Alu blister integrity assessments for export and domestic markets.
Recognised by the world's leading regulatory authorities
Laborate manufacturing facilities hold approvals from international health authorities across six regulatory frameworks — enabling supply to regulated and semi-regulated markets worldwide.
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WHO GMP
Pre-Qualification Programme
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USFDA
21 CFR Parts 210 & 211
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EU GMP
Annex 1 / Annex 11 Aligned
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ISO 9001:2015
Quality Management System
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Schedule M
CDSCO — New Schedule M 2023
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NABL
ISO/IEC 17025:2017
Markets with Approved Regulatory Standing
- India
- United States
- Kenya
- Nigeria
- Ethiopia
- Tanzania
- Uganda
- Ghana
- Zimbabwe
- South Africa
- Sri Lanka
- Myanmar
- Vietnam
- Philippines
- Cambodia
- Nepal
- Bangladesh
- Uzbekistan
- Kazakhstan
- Saudi Arabia
- Yemen
- Honduras
- Guatemala
- + 17 more
Audit-Ready at All Times
Regulatory inspection readiness is maintained year-round — not just before scheduled audits. Mock inspections are conducted quarterly by our internal audit team.
Dedicated RA & QA Function
A dedicated Regulatory Affairs team manages global dossiers, agency correspondence, and variation submissions to ensure continuous market compliance.
Zero Critical Observations
All USFDA and WHO inspections have concluded without critical (483/OAI) observations. Our CAPA track record demonstrates sustained compliance commitment.
Quality embedded at every stage of the product journey
From raw material qualification to post-market surveillance, quality oversight is continuous and documented — creating an unbroken chain of evidence from supplier to patient.
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Stage 1
Raw Material Qualification
Vendor qualification audits, Certificate of Analysis review, identity testing by FTIR, and pharmacopoeial testing for every incoming raw material and excipient lot.
Supplier Audit -
Stage 2
Manufacturing
Batch manufacturing against a validated master formula record. Line clearance, equipment qualification checks, and first-product verification before each production run.
GMP Production -
Stage 3
In-Process Quality Control
Real-time in-process testing by IPQA officers stationed on every production line — hardness, weight variation, disintegration, coating, and fill weight checks at defined frequencies.
IPQA Officer -
Stage 4
QA Batch Review
Full batch manufacturing record (BMR) review by QA — verification of every in-process test, deviation assessment, environmental monitoring data, and yield reconciliation.
BMR Review -
Stage 5
Authorised Product Release
Formal batch release signed by Head of Quality Assurance following satisfactory BMR review and passing of all QC specifications. Certificate of Analysis generated and archived.
QP Release -
Stage 6
GDP Distribution
Good Distribution Practice-aligned logistics with qualified third-party logistics partners. Cold-chain management, temperature monitoring, and shipment integrity verification for export markets.
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Stage 7
Post-Market Surveillance
Pharmacovigilance monitoring, market complaint handling, product recall readiness, annual product reviews, and trend analysis feeding back into the QMS for continuous improvement.
Pharmacovigilance
Quality & compliance questions answered
International buyers, regulatory visitors, and CDMO partners often require clear answers on our quality systems. Find the most common questions below.
Which international regulatory agencies have approved Laborate manufacturing facilities?
Laborate facilities hold approvals from WHO (Pre-Qualification Programme), USFDA (21 CFR Parts 210 & 211), CDSCO under the revised Schedule M (2023), and EU GMP-aligned certification. The Panipat Formulation Plant — Unit I (PLT-01) holds direct USFDA and WHO GMP approvals, and operates under NABL accreditation (ISO/IEC 17025:2017) for its quality control laboratory.
Active regulatory certificates are available on request for verified buyers, government procurement agencies, and CDMO clients under a signed NDA.
How does Laborate manage batch release — what is the process?
Every batch undergoes a complete batch manufacturing record (BMR) review by the Quality Assurance department. This review covers all in-process test results, environmental monitoring data, yield reconciliation, deviation logs, and raw material CoA verification. QC testing of finished product samples is conducted against all specifications — assay, dissolution, related substances, microbial limits, and packaging integrity.
Authorised release is signed by the Head of Quality Assurance. No batch leaves the facility before all criteria are satisfactorily closed. A Certificate of Analysis (CoA) with all test results is generated and archived for each released batch.
How are out-of-specification (OOS) results managed?
All OOS results trigger a formal investigation procedure aligned with FDA guidance (Guidance for Industry — Investigating Out-of-Specification Test Results, 2006). Phase I is a laboratory investigation to rule out assignable laboratory error. If Phase I cannot identify an assignable cause, a full Phase II manufacturing investigation is conducted.
The batch disposition decision — release, retest, reprocess, or reject — is made by QA based on the full investigation findings. All OOS events are recorded, trended, and reviewed at Annual Product Reviews. Repeat OOS on the same product triggers a CAPA.
How are Laborate QC laboratories accredited, and which standards apply?
The primary quality control laboratory at Panipat is NABL-accredited under ISO/IEC 17025:2017 — the internationally recognised standard for testing and calibration laboratory competence. NABL is the Indian National Accreditation Board for Testing and Calibration Laboratories, a signatory to ILAC MRA, meaning NABL-accredited test reports are recognised across 90+ countries.
All analytical methods used for product release are validated per ICH Q2(R1). Instruments are calibrated and qualified on documented schedules. Method transfers from R&D to QC are conducted under formal transfer protocols with acceptance criteria.
How does Laborate prepare for unannounced regulatory inspections?
Inspection readiness is a permanent operational state — not a pre-inspection event. Our approach includes quarterly internal mock inspections by the QA team, annual third-party audits by approved external GMP consultants, and ongoing CAPA tracking against open findings from previous regulatory inspections.
A dedicated Regulatory Affairs team maintains all facility master files (Site Master Files / Drug Master Files), manages international dossier submissions, and responds to agency queries within defined timelines. Our most recent USFDA and WHO inspections concluded without critical (OAI / Form 483) observations.
What quality documentation is available for CDMO clients and export buyers?
Laborate provides a comprehensive quality documentation package for all CDMO partners and regulated export buyers. Standard documents available include: Certificate of Analysis (CoA), Certificate of Manufacture (CoM), TSE/BSE Statement, Shelf-Life Extension Letters, Analytical Method Summaries, Validation Summaries, and Stability Data Packages.
Access to specific documents — including master batch records, Drug Master Files, and facility certification copies — is provided under mutual Non-Disclosure Agreements. For first enquiries, contact our Quality Affairs team via the enquiry form on the Contact page.
Quality questions?
Contact our Quality & Regulatory Affairs team for certification documentation, audit scheduling, CDMO quality enquiries, or technical quality queries.