Quality/GMPs

Julie Tilbury is a collection network liaison at Be The Match BioTherapies.

Articles

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

Real-Time Post-Apheresis Documentation Decreases Errors

Manuela Gottschall is Head of Risk and Project Management, Global Quality at Roche.

Marie Schommer is Quality Manager at Roche Diagnostics GmbH.

Federico Colombari is Quality Risk Management Specialist at Roche.

A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual Verification

A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Industry 1VQ Solutions:  Change in Size of Thermal Shipping Solution Used for Transport of Product 

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel. 

Best Practices for Developing a Third-Party Auditing SOP

Addition of a testing lab to an existing testing site as a Post Approval Change (PAC) is considered low risk when there is no change to testing procedure, specifications, equipment, and the additional lab is already approved by health authorities for other testing activities. Such PACs should be managed in the Pharmaceutical Quality System (PQS) only rather than requiring prior approval.

Industry 1VQ Solutions:  Addition of a Testing Lab to an Existing Testing Site

Séverine Allard is Head of Global Regulatory Affairs at RegCMC Vaccines.

Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi Vaccines.

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect. 

Industry 1VQ Solutions: Changes That Bring an Additional Restriction on the Product Compared to Registered Conditions

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

Pietro Forgione is the vice-president of strategy at IDBS.

A strong digital backbone is foundational in driving innovation.

Accelerating Time-to-Insight Across the BioPharma Lifecycle

 Washington Editor, jillwechsler7@gmail.com.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

Gamesmanship Escalates over FDA User Fee Legislation

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel. 

Regulatory/GMP Compliance