Labotec is a leading supplier of laboratory equipment in South Africa, providing comprehensive IQ/OQ documentation and certification services for pharmaceutical manufacturers maintaining GLP and GxP compliance. Their Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services form the backbone of quality assurance protocols that validate cold chain and laboratory equipment throughout the manufacturing process. Labotec’s portfolio includes GLP/GxP-compliant equipment specifically relevant to cold chain operations: Weiss Stability and Photostability Testing Chambers meeting ICH Q1A guidelines, ELGA Purelab Pharma Compliance water systems with FDA 21 CFR Part 11 compliance, and Miele Lab Glass Washers with ISO 15883 validation documentation. Their technical support team provides installation qualification services upon equipment delivery, ensuring each piece is properly validated, documented and certified for pharmaceutical use. Equipment features Wi-Fi connectivity for continuous monitoring and data logging, creating audit trails supporting ongoing compliance. Labotec’s local expertise encompasses South African regulatory requirements and SAHPRA guidelines, providing validation services for cold rooms, stability chambers, refrigerators, and freezers used in pharmaceutical storage and distribution.

Cold Chain Relevance: Cold room and stability chamber IQ/OQ/PQ validation; pharmaceutical storage equipment qualification; GLP/GxP compliance documentation