SPGL

Ensure the reliability and consistency of your laboratory operations with expert GLP auditing and compliance consulting.

Tailored state-of-the-art laboratory solutions and audit services for GLP and GCLP environments.

Integrated methodology combining engineering, construction, commissioning, and qualification activities for pharmaceutical and biotech projects.

Align your computer systems with stringent regulatory requirements through dedicated computer system validation and compliance consulting.

Independent witnessing agent, commissioning management service, and complete commissioning for biopharmaceutical, vaccine, medical and diagnostic device, and healthcare industries.

Professional consulting services for computer system validation, ensuring robust System Development Life Cycle (SDLC) establishment, data integrity, and regulatory compliance for computerized systems and IT-based clinical tools.

Achieve impeccable standards in your manufacturing processes through expert GMP compliance consulting and auditing services.

SPGL provides specialized documentation expertise and development of Turn-Over Packages (TOP) for regulated industries, ensuring high-quality packages that include all necessary up-to-date documentation for facility validation.

Preparation of validation plans ranging from single processing lines to site-wide Validation Master Plans (VMP).

Preparation and execution services for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Design, engineering, and cGMP audits of existing operations, facilities, validation activities, and mock inspections.

Combines the role of commissioning manager with commissioning execution, giving SPGL responsibility for all planning, management, and execution services.

Preparation and support services for User Requirement Specifications (URS) outlining facility, system, and utility requirements.

Quality assurance consulting services designed to elevate project standards.

Comprehensive laboratory auditing and compliance services encompassing facility audits, study audits, protocol audits, and data audits to ensure adherence to GLP, GCLP, CAP, and CLIA standards.

Expert consulting services including risk-based audit planning, inspection readiness training, mock inspections, and CAPA management.

Assistance in developing plans and rationales for process validation projects ensuring utilities, equipment, environment, and automation are fully integrated.

Assistance in developing data integrity policies, plans, procedures, audits, and risk assessments.

Maintain the utmost vigilance in monitoring the safety of your products through specialized GVP audit and compliance consulting services.

Preparation of Standard Operating Procedures for operation, maintenance, calibration, and advanced processing operations.

Validation services utilizing historical data to provide documentary evidence for facilities and processes in operational use that lack formal documentation.

Construction quality assurance services raising the gold standard in construction.

SPGL commissioning team compiles and monitors the commissioning schedule, ensuring all activities are executed efficiently and cost-effectively.

Design and review of Batch Records for various manufacturing processes.

Management of product and process transfers between sites ensuring compliance along the entire way.

Pre and post marketing audits covering pharmacovigilance system master files, case management, and risk management.

Mock inspections conducted to prepare companies for preapproval or routine GMP inspections.

Specialist GCP auditing and compliance consulting services provided globally by SPGL.

Consulting and development of validation plans and rationales for cleaning validation projects across aseptic, antibiotic, and biotechnology processes.

SPGL commissioning manager acts as an independent accepting authority for all M&E project testing, commissioning, and performance testing.

Auditing services for commercial partners, marketing partners, distributors, and service providers.

Consultation and practical interpretation of particular guidelines and regulatory requirements.

Consulting service for conducting risk assessments and criticality analyses for process facilities to classify systems into critical and non-critical impact.

Support in developing sterilisation strategies, plans, policies, and hands-on project execution.

Project delivery consulting and support covering EPC, CM Risk/Agency, and DB models.

Support in developing and executing Deviation Management and CAPA plans and strategies.

In-house training courses using formal presentations, workshops, and practical equipment demonstrations.

Specialist GCP auditing and compliance consulting services covering investigator site audits, system audits, mock inspections, vendor system audits, document audits, and quality management systems.

Process design consulting integrating quality and regulatory expertise from concept to basic engineering stages.

Application of analytical and statistical techniques to improve operational performance and eliminate waste.

Continuous commissioning, LEED commissioning, building simulation, and energy studies for facilities.