Auriga Research | WHO-Accredited Testing Laboratories in India

WHO-Accredited Testing Labs in India

Ensuring Global Standards with WHO-Accredited Testing

Auriga Research holds accreditation from the World Health Organization’s Prequalification Unit (PQT), affirming our compliance with WHO’s Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). This accreditation covers our Bangalore facility, enabling us to deliver high-quality testing and quality control services for finished pharmaceutical products and active pharmaceutical ingredients (APIs). Our WHO-prequalified services support manufacturers and licensees in meeting rigorous international standards, ensuring product safety, efficacy, and regulatory acceptance worldwide.

Importance of FSSAI Standards

Assuring Product Quality
- Verifies that pharmaceuticals meet WHO’s stringent standards, ensuring global quality and safety.
- Reduces risks of unsafe or ineffective products, supporting regulatory acceptance.
Building International Trust
- Positions Auriga as a reliable partner in WHO-compliant pharmaceutical testing.
- Facilitates market access by providing internationally recognized data and certifications.
Maintaining High Standards
- Adheres to rigorous WHO guidelines, ensuring consistent accuracy in laboratory practices.
- Conducts ongoing assessments to uphold WHO standards in all testing processes.
Streamlining Documentation and Reporting
- Prepares essential WHO-compliant documentation for smooth regulatory submissions.
- Provides detailed testing reports to support clients’ regulatory and quality control requirements.
Supporting Global Health Initiatives
- Enables safe access to markets by ensuring compliance with WHO’s pharmaceutical standards.
- Helps manufacturers meet quality benchmarks for global health product distribution.

How Auriga Research Can Help

Finished Product Analysis

Physical and Chemical Testing: Evaluates parameters like pH, density, and dissolution to ensure product integrity.
Identification Testing: Uses advanced techniques like HPLC, GC, TLC, and FT-IR for accurate ingredient verification.
Assay and Impurity Testing: Confirms active ingredients and screens for impurities to ensure safety.

Active Pharmaceutical Ingredient (API) Testing

Purity and Potency Verification: Ensures APIs meet potency standards using HPLC, UV-Vis, and other analytical methods.
Residual Solvent Analysis: Detects residual solvents, heavy metals, and moisture in APIs to verify quality.
Stability Studies: Conducts stability testing under ICH conditions to guarantee API durability.

Microbiological and Sterility Testing

Microbial Limit Testing: Screens for microbial contaminants, ensuring safe, sterile pharmaceuticals.
Sterility Testing: Confirms sterility, especially for sensitive products, meeting stringent WHO standards.
Antimicrobial Efficacy Testing: Assesses the effectiveness of antimicrobial agents for added product safety.

Method Validation and Quality Control

Method Development: Customizes analytical methods tailored to the specific pharmaceutical product requirements.
Validation Protocols: Establishes protocols to validate test methods for accuracy, precision, and reliability.
Ongoing Quality Checks: Conducts periodic checks to ensure consistent performance of validated methods.

Documentation and Compliance Support

WHO Documentation Preparation: Prepares and organizes all required documentation for WHO regulatory reviews.
Detailed Compliance Reports: Provides WHO-compliant reports to support regulatory submissions.
Audit-Ready Record Keeping: Maintains meticulous records for efficient WHO inspections and client reference.

Client Consultation and Support

Regulatory Guidance: Offers expert advice on WHO and GPPQCL compliance for pharmaceutical quality control.
Customized Testing Solutions: Tailors testing protocols to meet unique client needs, enhancing compliance.
Continuous Client Assistance: Provides ongoing support to address compliance questions and regulatory requirements.