QP or No QP, That is the Question

Transcription

1 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

2 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

3 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

4 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

5 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.

6 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

7 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

8 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

9 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

10 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

11 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

12 The Study Guide Training Providers The Training of QPs 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?

13 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.

14 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

15 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

16 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

17 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

18 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!

19 Thank you for listening Any Questions?

20 Contact Paul Graham Pharma Consulting Ltd Wansbeck Enterprise Centre Lintonville Enterprise Park Lintonville Parkway Ashington Northumberland NE63 9JZ t: +44 (0) f : +44 (0) m: +44 (0) e: paul@paulgraham-consulting.com w: