The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce delays in processing applications.
The MHRA is required to grant or refuse applications for manufacturing authorisations within 90 days of receiving a completed application. The MHRA receives over 800 manufacturing authorisation related applications each year and over 30% of these require further information before the MHRA can begin processing the application, causing delays.
The MHRA has identified 6 common mistakes made in applications and has provided guidance to help companies address these:
- Ensure that application forms are complete and attach all the supporting documentations.
- Only include activities that the company is capable of performing at the time of the application (and not those that it might perform in future).
- Ensure that the nominated key personnel have experience at the relevant site and knowledge of the site’s Pharmaceutical Quality System.
- Only name contract laboratories in the application if they are performing an inspectable activity such as testing of finished products prior to batch release or stability testing of finished products.
- Storage only sites for stability samples that do not conduct any testing and are not being stored for wholesale dealing purposes do not need be included in the application.
- Sites should be ready for inspection. The QP/QA team must have carried out a full scope self-inspection to confirm the site’s readiness for inspection and have an action plan in place to address any deficiencies identified.
The last point is particularly important as Inspectors must issue a GMP Certificate or a Statement of Non-Compliance (“SoNC”) within 90 days of the inspection. If the site is not ready or the Inspector is not satisfied with any corrective and preventative actions proposed by the QP/QA team, the Inspector may recommend that the application be refused or a SoNC issued. The applicant will incur additional costs as well as delays if a follow-up inspection is required or a new application has to be submitted.
The full guidance is available here.