Safety Takes Priority
Increasing the Role of a Qualified Person in the Pharmaceutical Industry
Pros & Cons - Complying with current regulations within the pharmaceutical industry is an increasingly complex and rigorous process as regulatory bodies continue to step up the already stringent rules put in place to protect public safety. In order to ensure that a new medicinal product passes all legal checks, pharmaceutical companies must invest considerable resources and expertise in research, development and manufacturing processes. Under EU regulations, pharmaceutical companies must employ the services of at least one QP (qualified person) to ensure all manufacturing procedures, paperwork, quality controls, storage systems and the medicinal product itself meets the legal standards required.
The concept of the QP role was first introduced in 1975 and is a mandatory requirement for companies involved in the manufacture of both human and veterinary medicinal products. In a number of cases, especially with smaller pharmaceutical companies, a contracted QP provides the service. A contracted QP has the same responsibilities and duties as an in-house QP, but is not permanently employed by the pharmaceutical company. The importance of the QP role is reflected in the strict regulations surrounding the qualifications and experience of a candidate. Under EU Directive 2001/83/EC Article 49, it states that a QP must have at least one formal qualification in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry or biology, as well as a minimum of two years experience in qualitative and quantitative analysis of medicinal products. In practice, most QPs have at least 10 years experience in a company (2 - 5 years with Production and 2 - 5 years with Quality, both Quality Control and Quality Assurance). Due to the complex criteria a candidate must fulfill to become a QP, an official register has been created and only certified candidates from the register can be employed in the QP role.
The Role of a QP
A QP is responsible for certifying every batch of a pharmaceutical product for release to market. It is the QP's responsibility to ensure that every stage of the manufacturing of a new drug meets all required legislation relating to Good Manufacturing Practice (GMP).
The Rules and Guidance for Pharmaceutical Manufacturers and Distributors, which is more commonly referred to as "The Orange Guide", collates European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. The guide features all EU regulations for GMP, detailed EU directives and a code of conduct for QPs to follow.
In order to pass a batch of new product as suitable for release to market, a QP must be satisfied that the manufacturer has suitable premises, equipment and staff to meet regulatory guidelines. The QP is also responsible for establishing and maintaining a system of complete transparency at all times. This means that all data on both the manufacturing processes and the drug itself, including perceived risks, must be carefully recorded and readily available for inspection. A QP must prepare regular reports for governing authorities and ensure that any request for information by regulatory authorities is fully answered. If a product is found to be in breach of any legislation, the company responsible for its release would face serious repercussions.
As well as ensuring that Quality Management Systems (QMS) are operational and each batch of drugs meets the required standards, a QP must also consider wider technical, ethical and professional obligations in terms of patient safety, quality and efficacy. The Code of Conduct supports the legal framework provided by EU directives and sets out operational guidelines for carrying out the functions of a QP. A QP has similar background to a Regulatory Inspector and act as the company's internal Inspector.
QP Vs. Manufacturer
Both pharmaceutical manufacturers and QPs have a duty to ensure that patients are properly protected and that medicinal products meet the appropriate requirements for safety, quality and efficacy. Despite this shared duty, there remains a perceived conflict of interest between the QP and a pharmaceutical company looking to release a new drug onto the market. While both must consider patient safety, a pharmaceutical company must also focus on profit. This means that the company effort focuses on getting a drug to market as efficiently and cost-effectively as possible. The primary legal responsibility of a QP is to certify each batch prior to release. If required standards are not met at anytime during the manufacturing process, the QP has the power to reject a batch for release or even halt production all together. Company profits are often calculated on a batch by batch basis, therefore if any batch is rejected it would reduce the profitability of the product and hence the company. If the release dates for a new drug have to be pushed back or scrapped altogether it has dramatic financial implications for the business.
The challenge for the pharmaceutical company is to establish Quality Management Systems in the early stages of process development in order to ensure that all legal standards and regulations are fully adhered to before any manufacturing has begun. This will help to maximise the chances of getting the manufacturing process correct and compliant with all regulations as quickly as possible - although both QPs and pharmaceutical companies alike will concede that getting it right the very first time is rare.
Making the Most of Your QP
To bring a new medicinal product to market requires a large financial commitment. There is a belief in some pharmaceutical organizations that employing a QP only serves to increase costs and prolong the entire manufacturing process. This means that pharmaceutical companies often overlook the long term benefits and knowledge that a QP can bring if recruited onto a project early enough in the process.
Although QP involvement early in the manufacturing process will increase initial set-up costs, it can result in a long term cost saving. A QP brought in early on the design stage can draw on expertise in research, production, quality control and project management to offer sound advice on implementing the necessary systems before the actual manufacturing process is started. A company that adapts the QP ethos when putting the manufacturing system in place is far more likely to get a drug through to release stage with the least amount of reworking possible. By investing time and resources into the plant and production processes earlier, in line with regulatory guidelines, the chances of manufacturing being stopped or delayed by the QP is reduced considerably. Under the Code of Conduct, a QP has a personal and professional duty to keep their knowledge and experience up to date, which covers changes to legislation, GMP standards, pharmaceutical quality management, product manufacturing and general work practices. Early QP involvement in a project gives companies an opportunity to act on current and applicable advice with regards regulatory compliance.
Similarly, utilizing the knowledge, experience and regulatory compliance understanding of a QP for the manufacture of established, licensed products brings significant benefits to an organization. Examples of this include activities such as active involvement with the continuous improvement of Quality Systems, training, coaching and mentoring. Such activities have delivered greater GMP understanding and awareness resulting in reduced risk of batch rejections or recalls.
The pharmaceutical industry needs to be commercially successful, but companies also have an ethical duty to ensure that public safety is paramount at all times. If a company views the QP role as yet another "legal hoop" it has to jump through in order to get a drug to market, it will never get the best from the QP role. A QP can help companies to ensure that public safety is protected at the same time as helping them cut costs and boost efficiency. In the short term, a QP can cause increased pressure on valuable project resources, but early involvement can result in cost savings on both current and future projects.