Quality assurance, Good Manufacturing Practice (GMP) and regulatory compliance are prerequisites to bringing safe, compliant and effective pharmaceuticals to patients. As we have witnessed first-hand this year, drug development can take place at a rapid pace and therefore quality assurance and QPs are challenged to keep pace with the evolving scientific and regulatory requirements.
In this Q&A with Ria Rhemrev-Boom, Sharp’s EU Qualified Person (QP), and Chris Bruyninckx, QA/RA Manager of Sharp Europe, we explore the benefits of partnering with a contract packaging organisation that can offer integrated QP services.
What is the role of the QP within a contract partner?
Bringing pharmaceutical products to the European market requires batch release by a Qualified Person (QP). The QP should have detailed knowledge of the different steps it takes to manufacture the final drug product. Sharp has built a framework to map all the steps in the manufacturing process across the supply chain and ensures that detailed information is available and reviewed before certifying the finished product.
During review the QP ensures that all regulatory requirements are met regarding importation, testing and marketing the product in the EU.
The rules around drug importation are complex, not always straightforward and are often accompanied with exceptions, a concern which has been further complicated by Brexit. When working for a contract partner, QPs can offer consultative support, helping marketing authorisation holders (MAH) with questions related to the importing of API’s and Bulk product into the EU.
The MAH is responsible for qualifying contractors in its supply chain. However, contract partners can help them to:
- Limit or optimise the number of players in the supply chain, for instance (if possible) by advising them on the choice of country of one of the contractors, and offering them both packaging and batch release
- Offering them services not only related to batch release, but also in relation to the ongoing requirements for the registration file, such as annual product quality reviews, which require the collection of information throughout the supply chain over that particular year;
- Audit services to qualify and review their contractors and suppliers ensuring they meet the requirements of EU GMP
- Set-up of the quality agreements
- Address complaints, deviations and OOS/OOT/OOE, etc
What are the benefits to pharma companies of contract partners offering QP services?
A lot of pharmaceutical companies focus on R&D, innovation and registration which often has the biggest positive impact on the value of the company and in turn therefore increases their opportunity to reinvest and innovate. This is fundamentally different to contract service organisations, whose raison d’être is to offer their clients access to capacity, processes and facilities based on GMP. One of the main factors in the increasing trend towards outsourcing is that it is often more cost-effective for pharma companies to seek collaboration with contract manufacturers who have the established capacity and infrastructure in place to deliver. Batch release is traditionally done by a QP within the MAH, but the MAH needs to be EU GMP certified which is no longer a given, so it follows that the outsourcing of batch release is preferred over investing in GMP infrastructure.
As contract packaging partners are downstream in the manufacturing cycle, delivering packaging services which ready the finished product for market release, it makes sense for MAHs, to ask whether these businesses can also offer QP and batch release services.
Finally, many innovative pharmaceutical companies are located around the world and may not have manufacturing activities in Europe; thereby lacking MAH presence and QP availability in the EU.
Has Brexit had an impact on batch release?
As of January 1st, 2021, the UK has left the EU and is now a ‘third country’ (a country outside the EU and the EEA). For pharma, this means that a ‘QP certification’ by the UK will have no value anymore when pharmaceutical products are imported into the EU/EEA.
In the past, many pharmaceutical companies from outside the EU entered the European market through the UK as the European Medicines Agency (EMA) was located in London and US-based manufacturers preferred UK based subsidiaries to enter the EU market. Brexit has put an end to this and redefined the landscape of pharmaceutical product importation into Europe.
At the time of writing, there is no Mutual Recognition Agreement (MRA) between UK and EU/EEA. As such, the following rules apply which impact QP release:
- Batches from medicinal products from UK need to be retested within the EU/EEA or an MRA country.
- EU QP needs to check at certification of EU importer;
- Reference samples should be taken and stored in the EEA;
- Retained samples should be located in the EEA.
- Additional paperwork is required at borders, which may disrupt the supply chain.
Has the role of the QP changed in recent years?
Over the last decade, a lot of additional requirements have been implemented and tightened in GMP systems (risk assessment, data integrity requirements, qualification of computerized systems), which have affected the role and activities of the QP. Not only within the GMP system of the company the QP is working for, but the way audits are performed at suppliers and contract manufacturers as well.
As economies globalize, this has led to more complex pharma supply chains. In order to audit and qualify all contractors in a supply chain, a QP will either need to travel extensively and/or develop good working relationships and trust other QPs across the supply chain. The latter is often a concern as the individual QP is ultimately accountable for the batch release.
The introduction of new technologies for the production and testing of active substances and bulk product, the introduction of innovative and personalized medicines (such as ATMP’s) into the market creates new challenges for QPs. Often, they may not have detailed knowledge or experience of the steps for which they have become responsible. This can lead to either MAHs and contract partners using several QPs with different backgrounds or the need for extensive training.
How can organizations differentiate themselves when it comes to quality?
Transparency on quality assurance offers an opportunity for organizations to differentiate themselves.
Through this lens, a key consideration for pharma companies should be the proliferation of data and information and the ease with which public perception can be swayed through social media.
Take the COVID-19 vaccines as an example. Groups of people have expressed concerns and do not want to be vaccinated due to the accelerated development in relation to other medicinal products, believing that this increases the risk of safety issues. People become involved and use social media to express their feelings, sharing information (often misinformation) and affecting the perception of the pharmaceutical industry.
Inspections conducted by national authorities increase transparency, and the neutrality of the information gathered in these audits can be leveraged to demonstrate the quality status of a particular GMP/GDP certified organisation and its products.
Offering QP batch release via a neutral third-party in relation to the MAH can also contribute to increased trust here. That person must have full access to the documentation and knowledge about the processes involved in order to make a correct and substantiated decision in order to release these batches to the market.
Partner with Sharp
With expert QP release services, we ensure that medicines manufactured, packaged and handled throughout the supply chain comply with EU GMP rules and all applicable regulatory standards.
Complemented by our cloud-based QMS, QualityOne, and an Electronic Batch Record infrastructure, our QP market release capabilities enhance Sharp’s packaging services. We help pharmaceutical and biotech companies around the globe to bring their products to the EU market faster and more efficiently.