Comprehensive Services & Supplies

User Requirement Specification (URS)

Define functional and compliance requirements for the system.

Risk Assessment

Identify and categorise risks based on GxP impact and criticality.

Validation Plan

Develop a master validation plan outlining scope, strategy, and responsibilities.

IQ / OQ / PQ Protocols

Execute Installation, Operational, and Performance Qualification protocols.

Traceability Matrix

Map all requirements to test cases ensuring full coverage.

Validation Summary Report

Compile findings, deviations, and formal approval documentation.

Design Qualification (DQ)

Verify that the design of the equipment meets defined requirements.

Factory Acceptance Test (FAT)

Inspect and test equipment at the manufacturer's site before delivery.

Site Acceptance Test (SAT)

Confirm equipment performs correctly after installation at the user site.

Installation Qualification (IQ)

Verify equipment is installed as per manufacturer specifications and drawings.

Operational Qualification (OQ)

Demonstrate equipment operates within defined operational limits.

Performance Qualification (PQ)

Confirm consistent performance under actual production conditions.

Stage 1 — Process Design

Capture process knowledge from development and scale-up activities.

Stage 2 — Process Qualification

Confirm the process design can be reproduced at commercial scale.

Stage 3 — Continued Process Verification

Ongoing assurance during routine production using statistical tools.

Cleaning Validation

Demonstrate that cleaning procedures effectively remove product residues and contaminants.

Risk-Based Sampling

Define acceptance criteria and sampling plans based on risk assessment.

Validation Report

Compile all data, deviations, and conclusions in a formal summary report.

HVAC System IQ/OQ

Qualify installation and operation of HVAC components including AHUs and ductwork.

Airflow Pattern Study

Visualise and document airflow using smoke studies and velocity measurements.

Particle Count Testing

Classify rooms per ISO 14644-1 at rest and in operation.

Pressure Differential Mapping

Verify pressure cascades between classified and unclassified areas.

HEPA Filter Integrity Testing

Perform DOP/PAO challenge tests on all HEPA filters.

Recovery Time & Environmental Monitoring

Measure clean-up times and establish EM programmes for ongoing compliance.

Audit Planning & Scope Definition

Define audit objectives, scope, criteria, and schedule with the client.

Document Review

Review supplier quality systems, SOPs, batch records, and regulatory submissions.

On-Site Audit Execution

Conduct facility walkthrough, personnel interviews, and process observations.

Gap Assessment & Risk Rating

Identify non-conformances and classify findings by risk level (Critical / Major / Minor).

Audit Report & CAPA

Issue detailed audit report with findings and corrective action recommendations.

Follow-Up & Effectiveness Check

Verify CAPA implementation and assess ongoing vendor performance.

Protocol Development

Define mapping objectives, sensor placement strategy, and acceptance criteria.

Sensor Calibration

Calibrate all temperature data loggers to traceable standards before use.

Mapping Execution

Deploy sensors and conduct studies under worst-case conditions (summer/winter).

Hot & Cold Spot Analysis

Identify temperature excursion zones and assess risk to stored products.

Real-Time Monitoring Setup

Recommend and qualify continuous monitoring systems for ongoing compliance.

Mapping Report & Qualification

Issue comprehensive report with data analysis, conclusions, and recommendations.

Requirement Assessment

Understand laboratory testing needs and recommend suitable consumable solutions.

Product Selection & Specification

Provide detailed product specifications, certifications, and compliance documentation.

Quality Verification

Confirm products meet pharmacopoeial and regulatory quality standards.

Supply & Delivery

Ensure timely, traceable delivery with proper cold-chain management where required.

After-Sales Support

Provide technical support, CoA documentation, and reorder management.

Needs Analysis

Assess production line requirements and identify suitable consumable solutions.

Vendor Qualification Support

Assist in qualifying consumable suppliers to GMP standards.

Product Specification & Approval

Provide technical datasheets, material safety data, and regulatory compliance certificates.

Supply Chain Management

Manage procurement, inventory, and timely delivery to production sites.

Ongoing Technical Support

Offer continuous support for product queries, substitutions, and documentation.

Requirement Review

Evaluate laboratory testing methods and identify required chemical grades and specifications.

Product Sourcing & Certification

Source chemicals from certified suppliers with full CoA and regulatory compliance documentation.

Quality Assurance Check

Verify purity, grade, and compliance with pharmacopoeial standards before supply.

Safe Packaging & Delivery

Ensure chemicals are packaged, labelled, and transported in compliance with safety regulations.

Documentation & Support

Provide SDS, CoA, and technical support for method validation and regulatory submissions.