Qualified Person Courses

The legislation assigns personal responsibility for these activities to a ‘qualified person’ and requires that every manufacturing site (including those manufacturing investigational medicinal products) employ the services of such a person.

Qualified Person Courses

Past surveys of the pharmaceutical industry* have predicted a shortage in the number of Qualified Persons (QPs) employed in the UK and therefore potential problems in getting drugs to market. That’s because the first generation of QPs is reaching retirement age, and there are now much stricter requirements for new recruits to gain QP status.  RSSL offer a range of qualified person courses adhering to all new requirements.

Many of the UK’s first QPs became eligible as a result of work experience, rather than by formal assessment. That can still be the case in some parts of Europe where QP status can be acquired without formal training. Indeed, when the original directive came into force in 1975, anyone working as a QP was allowed to keep their status. Similarly, anyone who was engaged in activities such as production supervision and/or analysis of active ingredients and finished product between 1975 and 1985, was eligible to act as a QP. Neither case required further assessment, and both were referred to as transitional QPs. A significant proportion of the UK’s QPs became eligible in this manor.

Qualifed Persons in demand

Now, as the expertise of the ‘old guard’ is steadily being lost from the industry, newly qualified QPs are in greater demand. Having QP status is rightly seen by many as being useful for career progression, and pharmaceutical manufacturers must be careful not to lose QP skills from their business.

Under the permanent provisions of the EU legislation (2001/83/EC) educational and experience criteria need to be fulfilled by anyone applying to become a QP. In the UK, 3 professional bodies are responsible for ensuring these criteria are met, and they jointly publish a study guide against which trainee QPs are ultimately assessed. The study guide is based around 11 subject areas made up of 3 foundation modules and 8 additional knowledge modules, and these are the modules in which RSSL Pharma Training offers instruction.

Fast-track QP qualification

Moreover, RSSL Pharma Training offers a fast-track route through the qualification process. Its modular courses allow delegates to be trained in the topics in which they need help, and critically, do not require delegates to be taken away from their workplace for many days at a time. The modules generally take only one or two days to complete, and their highly interactive nature facilitates individual learning. All courses can be adapted and presented at the client site giving an opportunity for cost savings when training larger numbers of delegates.

RSSL's QP training promises

• An outstanding success rate at the final viva assessment
• Compliance with the latest QP Study Guide requirements giving additional information and further detail where appropriate
• A fast-track approach, with all 12 training modules presented in one calendar year.
• Recognised expertise, with former assessors of the Royal Society of Chemistry's QP Assessment Panel conducting the training
• The key information needed to make the sensible judgements and rational decisions
• The opportunity to contribute to Continuous Professional Development (CPD)
• Acceptance by regulatory authorities outside of the UK

Pharmaceutical QP Training

The pharmaceutical QP training modules offered by RSSL Pharma Training are as follows

Foundation Module 1: Law and Administration

The QP must ensure that all legislative obligations are fully satisfied before any product is released for sale. They therefore need a comprehensive knowledge of all EU and National legislation for manufacture, storage and supply of licensed medicinal products. This module includes EU and UK legislation, various authorisation requirements, MRAs, role of Pharmacopoeias, organisation of the MHRA, EMEA and the VMD, and procedures for dealing with complaints and product recalls.

Foundation Module 2: Roles and Professional Duties

Qualified Persons are obliged to discharge their professional duties in accordance with the Code of Practice for Qualified Persons. It is the responsibility of the Qualified Person to certify that a product has been manufactured in accordance with its Marketing Authorisation, and with Good Manufacturing Practice (GMP). This module covers the principles and practice of current GMP and QA as given in European Directives and Guides on GMP including relevant regulations made under the Medicines Act 1968 and the current edition of the MHRA’s Guidance for Pharmaceutical Manufacturers and Distributors (“the Orange Guide”).

Foundation Module 3: Quality Management Systems

The course takes the concepts of GMP Quality Management and builds it into a total Quality System. This course is aimed at those involved in the establishment, implementation, maintenance and effective operation of a Quality Management System. It is ideally suited to anyone working in Quality or Production environments.

The Additional Knowledge Modules are as follows

Mathematics and Statistics

Participants are introduced to the basics of data evaluation and the practical application of basic statistical tools in pharmaceutical production and QA.

Medicinal Chemistry and Therapeutics

This 3-day course examines the workings of the body from basic physiology to the functioning of bodily systems and examines how the major drug classifications are used to treat and affect these areas.

Pharmaceutical Formulation & Processing

This 5 day module provides essential understanding of the properties of chemical compounds and how they interact with each other during manufacturing.

Pharmaceutical Microbiology

This module gives a through overview of the microbiological control of pharmaceutical products, and the issues associated with sterile and non-sterile pharmaceutical production.

Analysis and Testing

This module includes GCLP, interpretation of analytical data and non-conforming results, the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation, sampling, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials.

Pharmaceutical Packaging

The majority of all pharmaceutical recalls and errors are packaging related. This course closely examines all of the key stages of pharmaceutical packaging, from component manufacturers and suppliers to final product release including artwork control, labelling (including Braille) and packaging GMPs.

Active Pharmaceutical Ingredients

EU legislation requires that all active pharmaceutical ingredients (APIs) going into drugs that are to be sold in Europe meet Good Manufacturing Practices (GMPs) standards. This course deals with the key issues associated with both the chemical and biological manufacturing of APIs.

Investigational Medicinal Products

This 1 day course examines the legislation and GMP issues associated with Investigational Medicinal Products. It covers EU legislation on IMPs (2001/20/EC) and Annex 13 to the EU guide to GMP. Delegates will also learn about the principles of Good Clinical and Good Laboratory Practice.

An additional module in Biotechnology for QPs has also been added to the RSSL Pharma Training portfolio, taking delegates through the specific issues related to the production and exploitation of biotechnology products.

*source: PiR Group QP Salary & Benefits Reports