In a recent article in the latest European Compliance Academy GMP Newsletter,1 they publish highly opportune information in relation to where QP batch certification can occur. In the advent of the COVID-19 outbreak, and the necessity for all work to be conducted at home where possible, does it behove QPs to certify batches of Drug Products from home? Perhaps QPs are doing this already?
EU Directives and EU GMPs (Annex 16) do not specify where a QP should conduct batch certification. The interpretation of the requirements by national inspectorates are not harmonized across the EU, EEA or UK. Some European regulators have made their expectations clear when it comes to batch certification. In the UK, there is no regulatory requirement for a QP to be physically present at the site of manufacture/importation to perform the certification process. The MHRA have provided guidance on how remote certification must be conducted:2
- The QP must be able to demonstrate they are fulfilling their wider duties (which includes regular presence at the site and an active role in quality management).
- Where remote QP certification is employed, it must be described and controlled within the pharmaceutical quality system (SOPs and technical agreement if company employs a contract QP).
- Accurate and up-to-date information and relevant batch-specific information must be available to support batch certification and release.
In Ireland, there is a legislative requirement for the QP to be present at the authorised site when performing batch certification.3 Legislation permits the use of alternative premises if approved by the HPRA. An approval by the HPRA would be conditional on the following arrangements being in place:
- The certifying QPs require access to all information necessary to enable them to perform the batch certification steps, e.g. batch documentation, computerised systems supporting the Quality Management System (QMS), Regulatory Information System etc.
- The address where batch certification takes place will be recorded as part of the certification documentation, e.g. the QP’s home address.
- Any batches certified under this process would be documented within the deviation management system (if QMS procedures have not been updated to reflect this change in procedure) and a copy of the deviation should be filed with each batch.
- The recording of batch certification in the register (or equivalent document) would be contemporaneous.
If you are not sure about the approach of your inspectorate to remote QP certification during this unusual period, it would be prudent to notify your competent authority of your organisation’s intention to conduct batch certification remotely. In this notification, PharmaLex recommend confirming compliance with points A-D above with the agency in addition to raising and maintaining a temporary change record for the period where batches are implicated by the change in the certification location. Furthermore, the relevant competent authority should be provided with the information E-H below:
- Company Name
- MIA Number(s)
- Existing Address of Batch Certification and New Temporary Address of Batch Certification
- Intended Period for Change of Address of Batch Certification
- I. No. 539/2007 – Medicinal Products (Control of Manufacture) Regulations 2007 – Schedule 2, Paragraph 5.
If you require any further guidance on QP certification or the Quality Release process, please do not hesitate to contact us at email@example.com