FDA AND EMA COMPLIANCE EXPERTISE
CUSTOM SKID-MOUNTED PRE-TREATMENT SYSTEMS
COMPREHENSIVE VALIDATION DOCUMENTATION PROVIDED
CRITICAL UTILITY SYSTEMS EXPERTISE
P E D L Services Ltd manages essential systems for drug manufacturing, focusing on quality and risk reduction. Our expertise includes Water For Injection (WFI) produced via multi-effect distillation (MED) or membrane filtration to meet USP/EP standards, and Purified Water (PW) generated using reverse osmosis (RO) and deionisation (DI) for non-injectable drugs and cleaning. Distribution uses 316L stainless steel loops with zero 'dead legs' and continuous sanitisation to prevent biofilm. We also provide Pure Steam Generation (PSG) for sterilisation in place (SIP) of critical aseptic manufacturing equipment, as well as management of clean utilities, including clean compressed air (CCA) and speciality gases, ensuring particle- and oil-free delivery that meets ISO cleanroom standards. We also ensure water purity for hospitals and healthcare providers.
DIGITAL ASSURANCE: COMPLIANCE AND VALIDATION
We manage the digital records of physical systems to secure validation status and regulatory compliance. Our GxP IT infrastructure provides validated hosting, whether on-premise or cloud, for applications like LIMS and EBR, ensuring data integrity and disaster recovery. We integrate utility sensors (TOC, temperature) into a validated data historian to comply with 21 CFR Part 11 requirements, guaranteeing all electronic records are secure, attributable, traceable, and tamper-proof. Our team also delivers comprehensive validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), supporting audit-readiness and adherence to strict FDA and EMA standards.
