Quality Systems

The Catalent Gene Therapy Quality Control and Quality Assurance Groups (QC/QA) oversee the entire production process from the validation of equipment to the approval of the documents required (SOPs, batch records, validation reports, etc.) to release the CGMP product. All products are segregated and produced on a campaign basis with validated change-over and cleaning procedures deployed between each project. Our systems and procedures are developed and maintained to ensure CGMP compliance to applicable FDA and EMA regulatory requirements and standards.