gmp biologics manufacturing
Biologics Manufacturing Operations
Cebio can help in production, purification and scale-up of gmp biologics manufacturing (Vaccines) using insect cell-baculovirus system.
Computer Systems Validation
The FDA, Health Canada, MHRA, EMA, and other regulatory bodies require regulated companies to perform computer systems validation (CSV) on any software system used to collect, store, analyze, report or transfer data in the place of paper data in cGMP, cGLP, and cGCP environments.
Cebio consultants understand the process, science, infrastructure, and instrumentation as well as the regulatory agency audit processes. We provide customized validation services to clients to reduce validation risk.
cGMP Validation services
At CEBIO, we are current with the standards and requirements of regulating bodies (FDA, Health Canada, etc. ). We provide services the following areas:
• Validation Documentation - Preparation and Execution, Reports (Complete SDLC)
• IQ / OQ / PQ (Author, Review and Execute)
• GMP and Gap Analysis
• Computer System Validation
• Risk and Criticality Assessment
• Procedures and Policies
• Auditing and Audit Responses