TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies.
The 35 page draft is a revision of an 18 page 2008 guideline. A comparison of the two documents indicates that the main requirements have not changed. However, the 2010 revision shows more alignment with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and increased transparency on how the clearance process works. Comments are due by November 15.
Changes from the 2008 version include the addition of: ● references to PIC/S documents as models for the content of information requested for site master files, GMP contracts and validation master plans ● a “documentary evidence” appendix ● clearance process flow charts with target timing for each step ● six additional mutual recognition agreement (MRA) partners ● an appendix on how to use TGA’s electronic system for information submission, and ● a glossary.