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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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12: The onsite inspection

We conduct inspections according to internal procedures based on PI031-1 standard operating procedure team inspections. See our guidance on manufacturer responsibilities during an inspection.

For general information on inspections, see:

Avoiding improper influence

Inspections must be fair and impartial. Manufacturers need to avoid any activity that may cause improper influence including:

  • bribes
  • threats
  • provision of entertainment
  • provision of meals (other than simple working lunches where there is no alternative)

If improper influence is attempted, we will:

  • take appropriate action
  • record all details of attempted improper influence in the inspection file

Purpose of the inspection

The inspection will determine your compliance with the relevant GMP code, standards and regulations in relation to the scope of your application or the current licence or certification which is in force (referred to as the extent and boundaries of the inspection).

We will inspect the relevant:

  • facilities
  • equipment
  • staff
  • training
  • quality management systems

We may also conduct special inspections with a specific purpose, which are more focussed.

What we are looking for

We are looking for your understanding of the requirements for manufacturing therapeutic goods to be supplied to Australia. We will identify any particular areas of concern during our pre-inspection documentation review and inspect all areas relevant to the scope of the application for compliance with:

The emphasis and depth of the inspection depends on the risk level of the products and the manufacturing processes. We will also identify any particular areas of concern during our pre-inspection documentation review.

We expect to find the manufacture of every batch of every product complies fully with the requirements of the marketing authorisation and any other regulatory requirements relevant to the production, control and release of medicines, including the code of GMP. For example, we expect that:

  • processes for every product or product group are validated, when validation is required
  • every starting material is tested according to GMP requirements and agreed interpretations

We collect evidence by sampling. For example, we do not usually look at the records for every batch, but instead select a small number of batches to examine thoroughly.

We will inform you of all potential deficiencies we observe and give you an opportunity to provide any additional relevant information.

We do not advise how to remedy deficiencies.

If we notify you of an observed deficiency, you can provide additional information for the inspector to review. If you have additional information, we prefer you to provide this during the inspection.

Disputes and complaints

We prefer to resolve disputes and differences in views informally during the inspection whenever possible. However, for more serious concerns, follow our inspection complaint process.

Opening meeting

For a general description of the opening meeting, see: Manufacturer inspection - typical example.

At the opening meeting, the inspector or inspection team will:

  • clearly describe the inspection objectives, scope and relevant manufacturing principles
  • explain the inspection process and how feedback will be provided
  • provide you with an inspection plan
  • record attendance

Manufacturer guides and observers

Manufacturers have various responsibilities during an inspection.

We conduct the inspection in English. If we need to talk to people who cannot speak or understand English you will need to:

  • provide a guide with some technical understanding who can act as a translator
  • translate any documents that we request into English

The translator

Please ensure the translator can translate technical language. The translator needs to be able to translate a technical question asked by the inspector in English into your language, as well as translate technical information into English.

  • We may terminate the inspection if we cannot communicate effectively.
  • If the information cannot be properly translated to the inspector, this may adversely affect the inspection outcome.

The manufacturer's guides should:

  • assist the inspection team and act on the request of the inspection team
  • not influence or interfere with the conduct of the inspection

Guides are responsible for:

  • clarifying information or assisting in collecting information
  • ensuring the inspection team understands and respects site safety and security procedures
  • witnessing the inspection on behalf of the manufacturer
  • translating for the inspection team

The manufacturer can also appoint observers.

Conducting the inspection

We examine actual practices, documentation and records. We collect information during the inspection by:

  • interviewing personnel at all levels within the organisation
  • observing activities
  • reviewing and evaluating systems and procedures for compliance and effectiveness
  • taking photographs and copying documents
    • Where an inspector needs to take photographs or copy documents, they will discuss this with you before they do so
    • It is a standard condition that manufacturing licence holders allow inspectors to copy documents and take photographs (section 40(4) of the Therapeutic Goods Act 1989). Similar expectations apply when we are inspecting overseas.

At the end of each day we may hold a debrief meeting to discuss issues that arose during the day. These will be included in the written closing meeting summary we give you at the end of the inspection. You can provide additional information during the inspection to address any issues raised.

Closing meeting

We will hold a closing meeting at the end of the inspection between the inspection team and your senior management and any other staff nominated by your company.

At this meeting we:

  • summarise the findings and present any potential deficiencies
  • discuss any divergence of opinion between the manufacturer and the inspectors
  • discuss the conditions likely to be applied to the licence or certificate
  • explain the inspection close out process
  • record of attendance

We will provide you with a written closing meeting summary listing all potential deficiencies we have found. We provide this written summary so you will be aware of the content of the post-inspection letter. This allows you to start remedying any deficiencies immediately.

Do not confuse this written closing meeting summary with the post-inspection letter (PIL) or the inspection report we send you later.

You do not need to formally respond to the closing meeting summary.

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