Quality Control (QC) Testing / GMP

Comprehensive, validated quality control testing services for drug substances and finished drug products.

Analytical quality control is the foundation of pharmaceutical manufacturing, providing the documented evidence required to demonstrate that every batch of drug substance and drug product meets its predefined quality specifications prior to release. For Quality Control professionals, the reliability, accuracy, regulatory compliance, and turnaround time of analytical data are critical to ensuring efficient batch release and product quality.

AMSbiopharma provides a comprehensive portfolio of GMP-compliant quality control testing services, covering the full range of physicochemical, chemical, and functional assays required for the characterization and release testing of pharmaceutical products. All testing is performed using validated methods in accordance with applicable pharmacopoeial and regulatory standards.

Our services operate within a Quality Management System (QMS) aligned with Good Manufacturing Practice (GMP) principles, ensuring full traceability, controlled documentation, and data integrity procedures compliant with 21 CFR Part 11 and EU GMP Annex 11.

We conduct various analytical tests for industries like pharmaceuticals, medicinal cannabis, and veterinary. Our proficient team ensures high-quality and flexible execution of activities.

Our catalog of services include

Metabolomics applications

Stability Study Support (HPLC-UV, HPLC-MS/MS, GC-MS/MS)

Stability studies provide the analytical data required to establish shelf life, define storage conditions, and support regulatory submissions. A well-designed stability programme supported by validated stability-indicating analytical methods is a regulatory requirement under ICH Q1 for all drug substances and drug products.

AMSbiopharma supports ICH Q1-compliant stability programmes with validated stability-indicating methods for the determination of assay, degradation products, related substances, and other critical quality attributes. Our team manages sample receipt, analytical testing, and data management throughout the study. Analytical testing is performed using HPLC-UV, HPLC-MS/MS, and GC-MS/MS, as appropriate for the product and analytical requirements.

Key analytical capabilities

  • Design, execution, and analytical support for ICH Q1-compliant stability studies 
  • Validated stability-indicating methods using HPLC-UV, HPLC-MS/MS, and GC-MS/MS 
  • Data management compliant with 21 CFR Part 11 and EU GMP Annex 11

Appearance is a fundamental quality attribute of pharmaceutical products and a mandatory release test for all dosage forms. Deviations in colour, clarity, or particulate matter from predefined specifications may indicate product degradation, contamination, or manufacturing process failure.

AMSbiopharma performs validated appearance testing for colour, clarity, and particulate matter using calibrated visual and instrumental methods in accordance with applicable pharmacopoeial specifications and regulatory requirements.

Key analytical capabilities

  • Visual and instrumental appearance testing in accordance with Ph. Eur. and USP 
  • Colour assessment against pharmacopoeial reference standards 
  • Clarity testing for solution-based pharmaceutical products 
  • Particulate matter testing, including sub-visible particle analysis 
  • Applicable to parenteral, oral liquid, and semi-solid dosage forms 
  • Supporting documentation for batch release and stability studies

Assay and dosage unit uniformity are fundamental quality control requirements for all pharmaceutical products, providing quantitative evidence that each batch contains the intended amount of drug substance, uniformly distributed throughout the dosage units.

AMSbiopharma employs validated analytical methods across a broad range of analytical platforms, including UV/Vis spectrophotometry, HPLC and UHPLC with multiple detection techniques, GC, GC/MS, and LC/MS, selecting the most appropriate technology for each product. All methods are developed and validated in accordance with the Ph. Eur., USP, and ICH Q2(R2) guidelines.

Key analytical capabilities

  • Validated assay methods using UV/Vis, HPLC/UHPLC, GC, GC/MS, and LC/MS 
  • Content uniformity testing in accordance with Ph. Eur. 2.9.40 and USP <905> 
  • Applicable to solid, liquid, semi-solid, and parenteral dosage forms 
  • Method development and validation in accordance with Ph. Eur., USP, and ICH Q2(R2) 
  • Analytical support for method development, validation, and routine batch release testing 
  • Complete documentation to support regulatory submissions

The control of related substances—including process-related impurities, synthetic impurities, and degradation products—is one of the most critical quality control activities in pharmaceutical manufacturing. Regulatory authorities require all drug substances and drug products to be tested down to established reporting thresholds, with any impurity present at or above the applicable identification or qualification thresholds being appropriately identified and qualified.

AMSbiopharma provides validated analytical services for the identification and quantification of related substances using HPLC, GC/MS, and LC/MS, selecting the most appropriate analytical platform based on the physicochemical properties of each compound. Analytical methods are developed and validated in accordance with ICH Q3A(R2), ICH Q3B(R2), and ICH Q2(R2).

Key analytical capabilities

  • Validated HPLC, GC/MS, and LC/MS methods for the quantification of related substances 
  • Detection and quantification at or below the reporting thresholds defined in ICH Q3A(R2) and ICH Q3B(R2) 
  • Applicable to drug substances, intermediates, and drug products 
  • Impurity profiling in accordance with ICH Q3A(R2) and ICH Q3B(R2) 
  • Support for impurity limit justification and toxicological qualification 
  • Routine quality control testing with comprehensive supporting documentation

Inflammatory biomarkers are among the most widely evaluated endpoints in pharmaceutical development, providing critical mechanistic, pharmacodynamic, and safety data across immunology, oncology, autoimmune, metabolic, and central nervous system (CNS) diseases.

AMSbiopharma offers both targeted quantification of specific inflammatory biomarkers and broad inflammatory profiling approaches. Targeted assays provide the precision and validation status required for regulatory-grade pharmacodynamic data, while broad-panel approaches enable comprehensive inflammatory profiling to support biomarker discovery programmes.

Key analytical capabilities

  • Targeted quantification of individual cytokines, chemokines, and acute-phase proteins 
  • Broad-panel inflammatory profiling for biomarker discovery 
  • Development and validation of analytical methods for plasma, serum, and tissue matrices 
  • Applicable to immunology, oncology, autoimmune diseases, and metabolic disorders

Physical and physicochemical characterization provides critical quality attribute (CQA) data for pharmaceutical products. For liquid and semi-solid dosage forms, parameters such as pH, viscosity, and osmolality are critical determinants of product stability, while for parenteral products, they are essential to ensure physiological compatibility.

AMSbiopharma offers a comprehensive range of validated physicochemical testing services, covering the full spectrum of analytical parameters required for pharmaceutical development and quality control. All analyses are performed using calibrated and qualified instrumentation to ensure reliable, reproducible, and regulatory-compliant results.

Key analytical capabilities

  • pH measurement across a wide range of pharmaceutical dosage forms 
  • Viscosity determination using calibrated instrumentation 
  • Density and relative density determination using validated methods 
  • Refractive index measurement for identity confirmation and concentration determination 
  • Osmolality determination by the freezing-point depression method for parenteral products

Residual solvent testing is a mandatory pharmaceutical quality requirement under ICH Q3C(R9), which classifies solvents according to their toxicological risk and establishes permitted daily exposures (PDEs), reporting thresholds, and acceptance limits. Regulatory authorities require validated analytical methods with sufficient sensitivity to detect and quantify residual solvents below the specified limits.

AMSbiopharma provides validated headspace GC-MS methods for the quantification of ICH Q3C Class 1, Class 2, and Class 3 residual solvents, as well as volatile organic impurities, in drug substances, drug products, and excipients. Headspace gas chromatography coupled with mass spectrometry (HS-GC-MS) delivers the selectivity and sensitivity required for regulatory compliance and routine quality control.

Key analytical capabilities

  • Validated headspace GC-MS methods for ICH Q3C Class 1, Class 2, and Class 3 residual solvents 
  • Detection and quantification at or below the limits specified in ICH Q3C(R9) 
  • Applicable to drug substances, drug products, and excipients 
  • Method development and validation in accordance with ICH Q3C(R9) and ICH Q2(R2) 
  • Analytical support for regulatory submissions and routine quality control testing 
  • Profiling of volatile organic impurities beyond those specifically addressed in ICH Q3C(R9)