Compliance, Quality & Analytical Capabilities

Prism Industries Limited operates a quality-focused manufacturing and analytical framework designed to support product consistency, traceability, and compliance throughout the supply chain.

Equipment & Analytical Capabilities

Publicly Disclosed Analytical Equipment

Prism Industries Limited maintains analytical capabilities including:

  • • Agilent 1260 Infinity II HPLC System
  • • Additional LC-MS (Liquid Chromatography - Mass Spectrometry) instrumentation
  • • Endotoxin testing capability
  • • Laboratory analytical support equipment

Analytical Testing Capabilities

Our analytical capabilities include:

  • • High Performance Liquid Chromatography (HPLC)
  • • Liquid Chromatography - Mass Spectrometry (LC-MS)
  • • Endotoxin Analysis (LAL Testing)
  • • Heavy Metal Analysis Reporting
  • • Identity Verification Testing
  • • Purity Assessment
  • • Raw Material Verification
  • • Stability and Comparative Analysis

Quality Processes

Prism Industries Limited maintains documented quality procedures designed to ensure product traceability and consistency.

Batch Records

Batch manufacturing records are maintained and retained.

Batch-specific documentation supports traceability throughout the manufacturing process.

Sample Retention

Representative retention samples are maintained where applicable.

Retained samples support quality investigations and product review activities.

Supplier Qualification

Supplier verification assessments are conducted where necessary.

Supplier documentation and quality information are reviewed on a risk-based basis.

Incoming Material Controls

Incoming materials may be subject to:

  • • Identity verification
  • • Documentation review
  • • HPLC analysis
  • • LC-MS confirmation where required
  • • Visual inspection and conformity checks

Certificates of Analysis (COAs)

Certificates of Analysis are maintained and issued where applicable.

COAs may include:

  • • Product identification
  • • Batch information
  • • Analytical results
  • • Purity data
  • • Testing specifications
  • • Quality release information

Contamination Control Measures

Prism Industries Limited employs contamination control procedures designed to support product integrity and manufacturing quality.

Controls include:

  • • Sterile cleanroom manufacturing environment
  • • Class II cleanroom controls
  • • Filtered air systems
  • • Aseptic processing procedures
  • • Laminar flow workstations
  • • Controlled material handling practices
  • • Cleaning and sanitation procedures

Compliance & Standards

Prism Industries Limited operates quality systems aligned with recognised good manufacturing and laboratory practices.

Quality Framework

  • • GMP-aligned operating principles
  • • Documented quality procedures
  • • Batch traceability systems
  • • Material verification processes
  • • Controlled manufacturing practices
  • • Analytical verification protocols
  • • Continuous quality review processes

The company remains committed to maintaining robust quality standards, analytical integrity, and product consistency across all operations.