In the modern world it is increasingly common to see flexible, part-time or home working arrangements. Digital connections can allow us to continue to work effectively when we are away from the office. The pharmaceutical industry is no exception, and although some companies employ a part-time or contract Qualified Person (QP), there is still a need to maintain market supply whilst the QP fulfils their other duties or is restricted from travel.
All manufacturers and importers of licensed medicines must hold a Manufacturing / Importation Authorisation (MIA) which describes the specific activities for which the site is authorised, and names the individual(s) authorised to act as QP. The QP has a legal duty to ensure that every batch has been manufactured and checked in compliance with National law, the requirements of the Marketing Authorisation (MA) and Good Manufacturing Practice (GMP). Each batch must be certified by the QP prior to release for sale or supply.
Of course, the QP does not act alone and is reliant on the people and systems within the wider organisation to ensure that medicines are manufactured to a consistent, high quality. An effective pharmaceutical quality system is crucial in achieving this objective. The QP will work within, and have oversight of, the quality system. Typically, this can involve regular participation in the management review process, ensuring the site keeps up to date with regulatory changes, monitoring key performance indicators, reviewing supply chains and audit programs, training other staff, and taking part in the internal audit program. This oversight, together with a regular presence at the site, is key to the role of the QP.
Whilst many aspects of the quality system can be delegated to other personnel (EU GMP Annex 16 Section 1.7 lists 21 such functions), the legal duty of batch certification can only be performed by the QP. Clearly the manufacturer / importer will continue to operate on a day-to-day basis even when the QP is offsite, and the QP should have ongoing assurance in the quality system and the people. So does the QP need to be physically present at the site in order to certify a batch for release?
In the UK there is no regulatory requirement for the QP to be physically present at the site of manufacture or importation to perform the certification process for an individual batch. MHRA accepts the principle of remote certification by QPs, provided that the following aspects are sufficiently controlled.
The QP must be able to demonstrate they are fulfilling their wider duties.
The final certification of a batch is only a small part of the QP’s duties in ensuring medicines have been manufactured and tested in accordance with the Marketing Authorisation and EU GMP. As stated above, the decision to certify any product is underpinned by an ongoing confidence in the functioning of the quality system, and this relies on a regular presence at the site and an active role in quality management.
Inspectors will look for evidence of how often the QP is on site, and their active participation in monitoring the quality system.
Where remote QP certification is employed, it must be described and controlled within the pharmaceutical quality system.
Where remote certification of batches takes place, this should be described in the relevant site procedures. If the company employs a contract QP, the technical agreement should also mention remote certification, and specify how often the QP attends the site.
There is also a requirement in EU GMP that all batch certification is recorded in a register (or equivalent document). In the case of remote certification, the ownership and location of this register should be defined. If the register remains on site, who is responsible for keeping it up to date when the QP has remotely certified a batch? If the register resides with the QP, what are the arrangements for returning it to site – for example in the event of a recall, major investigation or regulatory inspection.
Accurate and up-to-date information must be available to support batch certification and release.
In order to certify a batch, the QP requires access to the relevant batch-specific information (such as batch records, QC test results, transportation records, etc), together with any relevant deviations, OOS reports or change records. In addition, they also rely on supporting information such as product trend data, the PQR, ongoing stability reports, process validation summaries, audit reports and technical agreements. The QP also needs access to the relevant parts of the Marketing Authorisation, any recently approved or pending variations, and visibility of the currently approved artwork.
Records could be provided in hard copy, by email, through VPN access to secure company drives, or other means (or even a combination of these options). Whatever methods are used to provide information to the QP should be defined in site procedures.
Similarly, once the QP has certified (or rejected) a batch, the process of communicating this decision back to the site also needs to be defined in SOPs, stating how the decision is recorded in the quality system. It is essential that batches are not released for sale prior to formal receipt of the QPs’ certification.
Every organisation has its own way of working. Whatever the arrangements, these need to be specified within the pharmaceutical quality system and in any relevant written agreements with contracted parties. Inspectors will review how this is managed to ensure that control is maintained, and products and patients are protected.
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