C5C: Class II Biologicals- Validations and Inspection Observations
Tracks
Courtyard Room Seminar
| Wednesday, November 20, 2024 |
| 9:45 AM - 10:30 AM |
Details
Class II biologicals play a vital role in treating various diseases and conditions by aiding the body’s repair and reconstruction processes.
The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues, and Human Cellular Therapy Products establishes requirements to ensure that therapeutic products adhere to safety standards and meet specifications.
This presentation will highlight key areas GMP non-compliance observed during recent TGA inspections with a particular focus on a lack of validation/qualification of critical processes, materials, utilities, and equipment. All of which could significantly affect the quality and safety of biological products.
Speaker: Nadia Saleh, GMP Inspector, Inspections Section
Nadia Saleh has been a GMP Inspector with the Blood Cell Tissue and Gene Therapy Team in the Manufacturing Quality Branch since 2019.She has worked in different areas within the regulatory environment of the TGA and developed extensive experience in the regulation of Medical Devices, Biological Medicines, Blood and Blood Components, Biologicals and Haematopoietic Progenitor Cells, including quality management, quality control and quality assurance in testing of finished biological products and medical devices.Nadia had also worked in NATA accredited testing laboratories including a hospital pathology and the TGA laboratories where she developed experience in analytical testing method techniques applicable to cellular and tissue testing, such as cytogenetic testing, and immune-histochemical staining techniques to identify specific subset of cells.
This presentation will highlight key areas GMP non-compliance observed during recent TGA inspections with a particular focus on a lack of validation/qualification of critical processes, materials, utilities, and equipment. All of which could significantly affect the quality and safety of biological products.
Speaker: Nadia Saleh, GMP Inspector, Inspections Section
Nadia Saleh has been a GMP Inspector with the Blood Cell Tissue and Gene Therapy Team in the Manufacturing Quality Branch since 2019.She has worked in different areas within the regulatory environment of the TGA and developed extensive experience in the regulation of Medical Devices, Biological Medicines, Blood and Blood Components, Biologicals and Haematopoietic Progenitor Cells, including quality management, quality control and quality assurance in testing of finished biological products and medical devices.Nadia had also worked in NATA accredited testing laboratories including a hospital pathology and the TGA laboratories where she developed experience in analytical testing method techniques applicable to cellular and tissue testing, such as cytogenetic testing, and immune-histochemical staining techniques to identify specific subset of cells.
