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Pharma Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Cleaning Method Validation

Validation that equipment is free from API residues and detergents between production batches, as per FDA cGMP guidelines.

Cleaning ValidationcGMPSwabRinse
Turnaround Time15–25 working days
Sample TypesSwab, Rinse water, TOC
Regulatory AcceptanceUSFDA, EMA, PIC/S
DeliverableProtocol + Validation Report
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen provides cleaning validation services to demonstrate that pharmaceutical manufacturing equipment is adequately cleaned between production batches. Our services include development and validation of analytical methods for swab and rinse samples, determination of acceptance limits, and preparation of cleaning validation protocols and reports per FDA cGMP and EMA guidelines.

Compendial Standards & Regulatory Alignment:
✓ FDA cGMP 21 CFR Part 211✓ EMA Cleaning Validation✓ ICH Q3A✓ PIC/S
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Turnaround Time15–25 working days
Sample TypesSwab, Rinse water, TOC
Regulatory AcceptanceUSFDA, EMA, PIC/S
DeliverableProtocol + Validation Report
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

✓
Swab sample analysis for API residuesExecuted with validated SOPs and full raw data audit trails.
✓
Rinse water analysis (HPLC and TOC)Executed with validated SOPs and full raw data audit trails.
✓
Acceptance limit calculation (MACO, 10 ppm, visual)Executed with validated SOPs and full raw data audit trails.
✓
Cleaning validation protocol preparationExecuted with validated SOPs and full raw data audit trails.
✓
Analytical method development for cleaningExecuted with validated SOPs and full raw data audit trails.
✓
Detergent residue testingExecuted with validated SOPs and full raw data audit trails.
✓
Worst-case product identificationExecuted with validated SOPs and full raw data audit trails.
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Recovery studies from equipment surfacesExecuted with validated SOPs and full raw data audit trails.
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Cleaning validation report preparationExecuted with validated SOPs and full raw data audit trails.
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FDA/EMA regulatory submission supportExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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HPLC (UV/PDA)

API residue quantification in swab/rinse

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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TOC Analyzer

Total organic carbon in rinse water

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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UV-Vis Spectrophotometer

Rapid screening of API residues

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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ICP-OES

Detergent residue (phosphate) analysis

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Limit Calculation

MACO and acceptance limits calculated based on therapeutic dose and batch size.

02
Stage 02

Method Development

Sensitive HPLC/TOC method developed and validated for swab/rinse matrices.

03
Stage 03

Recovery Studies

Swab recovery studies performed on representative equipment surfaces.

04
Stage 04

Validation Report

Full cleaning validation report with protocol, data, and compliance statement.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 15–25 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Cleaning Method Validation Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
Cross-Discipline Solutions

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Stability-indicating, residual solvent, dissolution, and cleaning validation methods per ICH/FDA/USP guidelines.

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