Gmp audit report template

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If an organisation manufactures or distributes both human and veterinary medicines, MHRA may carry out an inspection of both areas on behalf of the Veterinary Medicines Directorate. Every manufacturer and wholesaler has a risk rating or score and we prioritise inspections for those with the highest ratings or scores. You will be told about these inspections in advance, although under the short-notice inspection programme we may send little or no notification.

You will be given a full copy of the reasons for your risk rating once the inspection has closed. For GDP inspections your risk score is based on what activities take place on site and the number and type of deficiencies observed. This indicates the likely date of your next inspection and this information is included on the inspection report.

Inspections may sometimes be carried out with other MHRA inspections, such as with good clinical practice or good pharmacovigilance practice. This inspection checks if the manufacturer complies with GMP. We tell you about this inspection in advance.

You will have to complete either a GDP or GMP compliance report before an before an inspection unless it is a triggered inspection which are only notified at short notice. You should send completed compliance reports to the email address given by the inspector.

Hard copies of compliance reports will not be accepted. Site visits may include any facility or process involved in producing, purchasing and distributing medicines, including:. The inspection team may ask for additional documentation and samples for testing during the inspection. They may also change the focus of the inspection if they suspect serious non-compliance. At the closing meeting the inspector will provide feedback and discuss any deficiencies with you and agree timelines for corrective actions.

Deficiencies found during inspections are graded at 3 levels. The definitions below are summaries. For the full definition see page 47 of the EMA compilation of community procedures on inspections and exchange of information.

A deficiency which has produced or significantly risks producing a product which is harmful to humans or veterinary patients or which could result in a harmful residue in a food-producing animal.

Any departure from good distribution practice that results in a significant risk to patients. This includes an activity which increases the risk of counterfeit medicines reaching patients.

A deficiency which cannot be classified as either critical or major or there is not enough information to classify it as critical or major but which indicates a departure from good manufacturing and distribution practice. After the inspection closing meeting, you will receive a post inspection letter confirming any deficiencies found.

You must respond to the inspector by email to confirm the proposed corrective actions and dates for when these actions will be completed. The inspector will review your response. An unacceptable response may lead to compliance escalation if further requests for information are unsatisfactory. Guidance on responding to a post-inspection letter. The daily rate inspection fee includes preparation for, reporting and close-out of the inspection.

For such inspections, an office-based inspection fee may be charged for this additional time spent by the inspector s on such activities for example, reviewing CAPA plans, impact assessments and periodic CAPA status updates.

If your compliance is found to be poor but has not hit the threshold for regulatory action you may go through the compliance escalation process. The aim of this process is to support companies to achieve compliance before regulatory action becomes necessary. Once the process has been completed you will be returned to the routine risk-based inspection programme.

However you could still be referred for regulatory action if you do not make the necessary improvements. The process may also be used if the Inspection Action Group has closed their case referral but the company to be monitored until remedial action plans have been completed. The GMP Inspectorate has compiled an anonymised raw data set, so that stakeholders can do their own tailored analysis of our findings specific to their supply chain.

If the inspector finds critical deficiencies or that agreed action plans from previous inspection deficiencies have not been resolved they will contact the Inspection Action Group IAG. The IAG can refuse or suspend your licence, increase inspection visits or request a meeting with the licence holder.