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 16th 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

• utside 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

• f 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