Release Testing
GMP release testing aligned with approved specifications for confident batch release.
Confident batch release testing
Testing spans raw materials, packaging components, and finished products in support of batch release.
Groupe PARIMA performs release testing starting with raw materials and packaging components. Incoming testing confirms identity and quality attributes to support material use and reliable downstream processing.
Finished product release is supported by physicochemical and microbiological testing conducted in our internal GMP laboratories using validated or qualified methods aligned with approved specifications.
Release activities
Release testing activities span materials, components, finished products, and stability to support batches across development and commercial stages.
API and excipients testing
Active pharmaceutical ingredients and excipients are tested to confirm identity and critical quality attributes prior to use in manufacturing.
Packaging components
Primary packaging components are evaluated to confirm identity and defined attributes relevant to product protection and compatibility.
Finished drug products
Finished products are tested using physicochemical and microbiologically validated methods aligned with release specifications.
stability testing for shelf life
Stability testing supports release and shelf‑life claims by monitoring product attributes and trends over defined storage conditions.
Chemistry Testing Capabilities
Our in-house equipment supports stage-appropriate method development and routine testing across chromatography, particle sizing, physical testing, and dissolution.
01
Potency determination
Quantitative analysis to confirm active ingredient concentration and ensure therapeutic efficacy.
02
FTIR identification
Fourier-transform infrared spectroscopy for rapid and reliable compound identification.
03
Impurity profiling
Detection and quantification of impurities and degradation products to support product safety and shelf-life evaluation.
04
Residual solvent analysis
Ensures residual solvents are within safe, regulatory-approved limits, supporting compliance and patient safety.
05
Dissolution performance
Evaluates drug release profiles to predict bioavailability and support product performance claims.
06
Analytical testing
Analytical testing includes viscosity, pH, moisture, particle and droplet size, density, and deliverable volume to support formulation performance.
Release testing at Groupe PARIMA supports predictable batch disposition through controlled, specification‑driven testing.
Microbiology Testing Capabilities
Comprehensive microbiology testing to support product safety, quality control, and compliance with USP and EP requirements.
01
Aerobic Microbial Enumeration
Measure aerobic bacteria using validated method in accordance with USP <61> and EP 2.6.12 to assess overall microbial load.
02
Fungal Microbial Enumeration
Quantify yeast and mold levels using a validated analytical method in accordance with USP <61> and EP 2.6.12 to ensure product safety.
03
Microbial Suitability Testing
Screen for objectionable microorganisms as defined in USP <62>, USP <60>, and EP 2.6.13, based on dosage form and intended use.
04
Microbial Identification Testing
Identify microbial isolates to support contamination investigations and corrective actions.
05
Preservative Efficacy Testing
Confirm preservative system efficacy in multi-dose products in accordance with USP <51>.
Resources
Access technical insights and guidance to support informed decisions around release testing and analytical strategy.