13: The post-inspection letter (PIL)

We prepare a post-inspection letter (PIL) that records any deficiencies identified during the inspection and categorising them as critical, major or other. The deficiencies reference specific clauses in the GMP code, to identify which compliance requirement was not met.

The PIL is not a comprehensive inspection report.

The purpose of the PIL is to formally notify the manufacturer of the deficiencies identified during the inspection. The content of the PIL should not be a surprise because it will be similar to the written closing meeting summary provided at the closing meeting of the inspection.

The PIL is usually emailed to the manufacturer within four weeks of the inspection; however, it may be sent sooner where serious or significant compliance issues are identified.

Classifying deficiencies

We classify deficiencies as critical, major or other.

You must respond to all deficiencies listed in the PIL, following the included instructions.

Unacceptable rating

If your site is significantly non-compliant, you may be issued an unacceptable rating. An unacceptable rating means we will consider potential regulatory action to protect public health, including refusing to grant a new licence or suspending or revoking a licence which is in force.

If your compliance is rated as unacceptable, or you receive two consecutive A3 ratings where a licence or certification is in force, we may take the following actions:

• review the inspection findings
• undertake a risk assessment of the manufacturer and any goods manufactured at the site, if applicable
• prepare recommendations to ensure resolution by the manufacturer of any compliance issues
• prepare recommendations for regulatory and/or enforcement action

Refer to our guidance on the management of GMP compliance signals for further information on our regulatory compliance framework and regulatory actions for manufacturers of medicines and biologicals.