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GMP clearance for overseas manufacturers

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16 May 2011

Appendix H - Manufacturer Profiles

What they are

Manufacturer profiles will function as a cumulative repository of information held by the TGA about a manufacturing site with a GMP clearance. They will apply to all overseas sites whose clearance was not gained under the MRA arrangement. They will allow for a more effective clearance system by:

  • Helping sponsors to fulfil their obligations of keeping their GMP evidence for manufacturing sites up to date
  • To allow a risk-based decision to be made as to whether a compliance verification or on-site audit is required
  • Ensure that on-site audits are only scheduled as necessary and compliance verifications are undertaken wherever possible

What information they will contain

  • A list of all sponsors with a clearance for the site
  • The combined scope of the clearances
  • Activities performed at the site (including activities not directly related to Australian marketing authorisation)
  • Any physical changes to the site managed under change control
  • Any significant variations to licenses, company ownership, QA personnel etc
  • List of recent (<3 years) and forthcoming (<6 months) audits by competent authorities
  • List of any regulatory action taken against the company by any overseas regulator (eg warning letters, mandated recalls, license suspensions etc).

How it will work

In order to generate and maintain a manufacturer's profile, the TGA will request that the manufacturer complete a periodic update questionnaire. This needs to be completed and returned before the audit application can be processed. A blank questionnaire will be available on the TGA website.

A provision will exist for the manufacturer to return the questionnaire directly to the TGA if there is a concern over commercially sensitive information it contains.

Once a profile is established it will be periodically updated by the TGA, for example every 18 months. At that time the manufacturer will be sent the questionnaire again and asked to provide any updates to the information currently held on the database.

Some information they contain will be sourced from Site Master Files. They will also contain details of recent audits by competent authorities, any regulatory actions taken by or against the company since the last questionnaire and the outcomes of these actions. With this information a risk-based decision can be made as to how the TGA should continue issuing clearances for the site.

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