Release for Supply – TGA

Description

Our Release for Supply – TGA training course will help you understand regulatory expectations and TGA guidelines for Release for Supply (RFS) and Release for Further Processing (RFFP). It is ideally suited for:

• TGA manufacturing licence holders (MAH/medicine manufacturers in Australia)
• Manufacturers granted a GMP clearance by the TGA
• Others seeking to supply medicinal products to the Australian market

The course is based on TGA publication and insights from industry experts (consultants) and includes an overview of expected content in GMP Agreements with contract manufacturers, and the qualifications and responsibilities of the Authorised Person (AP) for medicinal products being marketed in Australia.

Topics include:

• Release for Supply (RFS) procedures and TGA expectations
• Lists of medicines that must comply with TGA guidelines for RSF procedures
• Details of RFS procedures and the PQS
• Release for Further Processing (RFFP) procedure TGA guidelines TGA
• Importance of the PQR and ongoing stability programs
• Compilation of the PQR and access requirements
• Batch traceability and shared responsibilities for recalls
• Complaints, deviations and recalls in view of RFS
• Requirements for stability programs and shelf-life statements
• Responsibilities of an Authorised Person(s)/Qualified Person
• Qualifications and Training expectations for role of Authorised Person
• TGA requirements for Sponsor agreements with manufacturers (GMP Agreements)
• Contract sites in multiple-site manufacturing
• Sharing information including the Marketing Authority with the Authorised Person
• GMP Agreements (inclusions)

Snapshot of this course:

• This course focuses on the essentials of Release for Supply (RFS) and Release for Further Processing (RFFP) requirements for ATRG listed medicines.
• The course is ideally suited for Marketing Authorisation Holders (MAHs), Sponsors, and manufacturers with GMP clearances.

In brief, this Release for Supply – TGA training course (available online, one user per licence) will assist Authorised Person(s) and other quality management professionals and contract manufacturers involved with ensuring the following GMP compliance measures:

• Release for supply procedures (RFS) – TGA / Australia
• Release for further processing procedures (RFFP) – – TGA / Australia
• Contract manufacturers/multi-site manufacturing
• GMP Agreements and technical arrangements
• Product Quality Reviews (PQRs)
• Reporting/Compilation of complete PQR
• Stability Program monitoring
• Shelf-life/stability statements
• Complaints and deviations (CAPA)
• Employee Training Program Managers in the Pharmaceutical industry

Who should take this Release for Supply – TGA online training course?

The course should be completed by Authorised Persons, Quality Teams (including self-inspection professionals/auditors/complaints handling teams), and other cGMP compliance professionals in the pharmaceutical industry.

Examples: Sponsors/manufacturers of medicines for the Australian market (TGA licence holders/MAH), pharmaceutical product importers (intermediates and bulk products), and non-Australian organisations with GMP clearances, including but not limited to.

• Authorised Person(s)
• Operations Managers
• Pharmaceutical Quality Department teams / Quality Managers
• Department Managers
• Sponsors of medicines with GMP clearances from the TGA
• Sponsors of Clinical Trials (Phase II and onwards)
• Owners/Operations Managers
• PQS personnel conducting self-inspections
• Professionals involved with
  • batch traceability records
  • complaints handling
  • product recall procedures
• Research personnel in Phase II Clinical Trials
• Anyone involved in RFS/quality system management
• Logistics Managers for shipping of intermediates and bulk products

Course Benefits:

The training course will assist Authorised Person(s), Operations Managers/Quality Personnel (and Clinical Trial researchers) to better understand their legal obligations in relation to release for supply procedures and signatures (e.g. GMP/RFS regulatory compliance responsibilities including stability program monitoring/batch traceability requirements).

The key benefits of this release for supply/release for further processing (TGA guidelines) online training course include understandings of:

• Responsibilities of the Authorised Person
  • example of education requirements
  • knowledge and skills training requirements
  • professional development training expectations
  • role requirements
• Reliance on PQS and RFS/RFFP procedures of overseas manufacturers
  • delegation of responsibilities
  • PQR monitoring
  • signature requirements
• RFS liability of the Authorised Person
• Requirements for Release for Supply procedures in the PQS
• Regulatory Authority expectations for release for supply (RFS) and release for further processing (RFFP)

TGA inspections and expectations for RFS and RFFP procedures and batch traceability recordkeeping