QP or No QP, That is the Question Paul Graham Joint NEPIC ISPE CPI - PowerPoint PPT Presentation

QP or No QP, That is the Question Paul Graham Joint NEPIC ISPE CPI Seminar Pharmaceutical & Biotechnology Sector – Opportunities & Developments in the NE 16 th February 2011 www.paulgraham-consulting.com info@paulgraham-consulting.com

Presentation Agenda • My Background • History of the QP • What the Law says • Recent Developments – Clinical Trials Directive – EU Paediatric Regulation • Demographics • Using Consultant QPs – Disadvantages – Constraints – Advantages • Summary

My Background • Over 30 years in QC and QA in large pharma and CMO companies on commercial and IMP sites throughout the UK • 15 years as QP • Moved into QP Consultancy in 2009 • Named on 2 licences as a QP and 2 as RP • Support major CMO and several biotech SMEs

History of the QP • 75/219/EEC – Article 17 – Requirement for a licence holder to have at least 1 qualified person – Article 19 – requirement for the licence holder to enable the QP to perform their duties – Article 21 – Competent authority to ensure each licence holder has the services of a QP, permanently and continuously and the QP fulfils the requirements for becoming a QP

History of the QP • Article 22 – QP to certify that each batch has been manufactured and tested in accordance to the marketing authorisation and GMP and the release is recorded in a register or equivalent. – Also covers imported medicinal products from outside the EEA – importation testing and QP release.

History of the QP • Article 23 – education and experience requirements for QPs • Article 24 – transitional arrangements for persons performing batch certification at the date the directive came into force • Article 25 – code of conduct and administrative procedures for member state

History of the QP • Directive 2001/20/EC – Clinical Trials Directive, GCP and GMPs for IMPs and need for IMP QP. Transitional arrangements for IMP QPs • 2001/83/EC, As amended by 2004/27/EC, updates 75/319/EEC

Recent developments • Clinical Trials Directive effective in 2004 required all IMP manufacturer’s to obtain an IMP licence and the services of a QP – QP could be either transitional IMP or permanent provision QP – 2 stage release process – technical release (QP certification against GMP and Product Specification File) and Regulatory release (CTA approval, ethics committee approval) – Update in QP study guide to include IMPs

Recent developments • EU Paediatric Regulation (EC) No 1901/2006 – Potential increase in the number of clinical trials for paediatric indications of existing and new medication – Allows for an extension to the patent – Medicines for children research network

Requirements for becoming a QP • Degree (or equivalent) in Life Sciences or Pharmacy • Member of one of the professional bodies RSC, SOB, RPS • 2 years experience (or 1 year for Pharmacist) in a licensed facility, not API • Acquiring the body of knowledge in the QP Study Guide • Sponsor mentoring and assessment • Viva by the professional Bodies • Named on manufacturer’s licence and accepted by • Continuing Professional Development

Demographics • Reduction in the number of available QPs due to retirement of transitional QPs • Increased requirement for QPs with the CTD, initially tempered by the IMP transitional arrangements • Very few pharmacist QPs coming through the pipeline • Increases in remuneration to attract QPs from other companies • Increase in the number of contract QPs

The Training of QPs • The Study Guide • Training Providers – PIAT Manchester University – NSF-DBA/Strathclyde University – RSSL – Brighton University – IAGT Group – University of Greenwich at Medway • QP Course used to be run by Sunderland University – why not Re-energize?

The QP Study Guide • Foundation Knowledge Requirements – Pharmaceutical law and administration – The role and professional duties of a Qualified Person – Quality management systems • Additional Knowledge Requirements – Mathematics and statistics – Medicinal chemistry and therapeutics – Pharmaceutical formulation and processing – Pharmaceutical microbiology – Analysis and testing – Pharmaceutical packaging – Active pharmaceutical ingredients – Investigational medicinal products.

CPD • Requirement for QP to maintain and expand their knowledge of current legislation and best practice – Quality Risk Management – Supply chain pedigree – Part II – GMPs for APIs – Annex I sterile products • Trainee QP and QP meetings held by the Pharmaceutical Quality Group, NSF-DBA and RPS • JPAGroup Meetings Useful

Strategies to manage the reducing number of QPs • Internal succession planning – Ongoing QP development programme – Not a fill the gap approach – Good investment for the future • Recruit externally – Cost, managing the increased expectations of QPs • Use of consultant QPs – Mentoring and support of trainee QPs – Named on licence to cover interim gaps

Using Consultant QPs • Disadvantages – Chose your consultant/contractor carefully to ensure that they have the skills and experience you need and that they will fit into your company culture. – Can be a costly alternative to succession planning if not deployed appropriately – Staff Turnover is a cause for concern with the regulator • Constraints – MHRA frown upon a QP being named on too many licenses. – The contract needs to benefit both parties – Need to maintain knowledge of site changes and GMP compliance through regular site attendance

Using Consultant QPs • Advantages – They can bring in a lot of experience into an organisation – Can bring current best practice into an organisation – Can develop a quality system and for biotechs entering the clinical arena – Can bring a fresh pair of eyes to critique ‘tired’ quality systems – Act as a stopgap until succession planning/external recruitment delivers permanent employee QP – Can mentor and support a trainee QP – Extensive network can help to arrange site visits for trainee QPs to gain experience in other dosage forms

Summary • Increasing pressure on QP availability • Need to establish an internal succession planning process for QPs • Consultant QPs can help with SMEs entering the clinical arena and with medium/large pharma with mentoring and support of trainee QPs and to fill a stop gap • QP or no QP?...... It a no brainer – its the Law!

Thank you for listening Any Questions?

Contact • Paul Graham Pharma Consulting Ltd Wansbeck Enterprise Centre Lintonville Enterprise Park Lintonville Parkway Ashington Northumberland NE63 9JZ • t: +44 (0)1670 528 416 • f : +44 (0)1670 528 440 • m: +44 (0)7545 922 652 • e: paul@paulgraham-consulting.com • w: www.paulgraham-consulting.com