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GMP clearance for overseas manufacturers
Appendix C - Explanatory notes for documentary evidence
GMP Agreements with manufacturers
Matters required to be contained in the GMP agreement are outlined in Chapter 7 of the PIC/S Guide to GMP for Medicinal Products, January 2009.
Particular consideration in the assessment will be given to the responsibilities for validation, stability, complaints, recall, release for supply, testing methodology and change control.
Where the Australian sponsor is a subsidiary of the overseas manufacturer who conducts the step of Release for Supply (and other manufacturing steps) then the TGA accepts that a formal GMP agreement may not exist. In this circumstance, the sponsor must provide the TGA with a written explanation of the arrangements.
Procedure(s) for Release for Supply of Finished Products/APIs
Release for Supply procedures detail the arrangements used to ensure that each batch has been manufactured and checked for compliance with the requirements of the marketing authorisation or in the case of APIs, with relevant specifications.
Note that a GMP Clearance for the manufacturing step, Release for Supply (only) to another manufacturer for further manufacturing will not be granted for intermediate or bulk products.
Product Quality Reviews
Product Quality Reviews are mandatory for APIs, and for medicine finished product dosage forms.
Product Quality Reviews are used to assess the effectiveness of controls and processes on the quality of manufactured products
As outlined in clause 1.4 of the PIC/S Guide to GMP for Medicinal Products (PE 009-8, January 2009), Product Quality Reviews should normally be conducted annually, and the results of the review evaluated by the manufacturer and the sponsor. Some of the items to be reviewed are:
- Starting materials including packaging materials used in the product.
- Critical in process controls and finished product results.
- Significant deviations, non-conformities, their related investigations, and the effectiveness of resultant corrective and preventative actions.
- Changes carried out to processes or analytical methods.
- Stability monitoring program and adverse trends.
- Quality related returns, complaints, recalls and the investigations performed at the time.
- Contractual agreements.
Site Master File (SMF)
A Site Master File or equivalent document will detail the facilities, operating structure, quality management system, manufacturing equipment and activities of the manufacturing site(s). This is used to understand the nature and operations of the manufacturer.
Guidance for preparing a SMF can be found in The PIC/S document PE 008, Explanatory Notes for Industry on the preparation of a Site Master File.
Manufacturers may supply other documents, such as a Plant/Equipment File or a Quality Manual, which individually or collectively provide the same details.
Validation Master Plan (VMP)
As outlined in Annex 15, clause 4 of the PIC/S Guide to GMP for Medicinal Products, January 2009, a Validation Master Plan should contain data on at least the following:
- Validation policy.
- Organisational structure of validation activities.
- Summary of facilities, systems, equipment and processes to be validated.
- Documentation format: the format to be used for protocols and reports.
- Planning and scheduling.
- Change control.
- References to existing documents.
The Validation Master Plan is used to assess the company's identification of the scope and extent of validation and qualification requirements for its operations, the status of validation activities so identified, and the level of assurance that the company has addressed the control of critical aspects of its operations.
A Validation Master Plan is not required for GMP Clearances involving QC testing or Release for Supply steps only.