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Introduction to PPDs Regulatory requirements and rationale

Introduction to PPDs Regulatory requirements and rationale. Overview. Background to the HTA and its regulatory remit Introduction to Preparation Process Dossiers (PPDs) European Union Tissues and Cells Directives (EUTCD)

ethan-bentley
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Introduction to PPDs Regulatory requirements and rationale

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  1. Introduction to PPDsRegulatory requirements and rationale

  2. Overview • Background to the HTA and its regulatory remit • Introduction to Preparation Process Dossiers (PPDs) • European Union Tissues and Cells Directives (EUTCD) • Human Tissue (Quality and Safety for Human Application) Regulations 2007 • Authorisation of tissue and cell preparation processes • Preparation Process Dossiers

  3. Post mortem • Research • Anatomy • Public display • Approval of living organ donation • Organ donation and transplantation • (ODT) • Tissues & cells for patient treatment • (Human Application) Sectors Regulated by the HTA

  4. European Union Tissues and Cells Directives (EUTCD) • Parent Directive (2004/23/EC) and two technical Directives (2006/17/EC & 2006/86/EC) • Set out to produce a harmonised approach to the regulation of tissues and cells for patient treatment across Europe • Directives set a benchmark for standards that must be met when carrying out activities involving tissues and cells for patient treatment • Focus on Quality and Safety • Requires that appropriate systems are in place to safeguard the procurement, testing, storage, import/export and processing of tissues and cells intended for human application

  5. Authorisation of preparation processes2006/86/EC - Annex II • The competent authority shall authorise each tissue and cell preparation process after evaluation of: • the donor selection criteria and procurement procedures • the protocols for each step of the process • the quality management criteria • the final quantitative and qualitative criteria for cells and tissues • This evaluation must comply at least with the requirements set out in this Annex

  6. Authorisation of preparation processes2006/86/EC - Annex II – Part B • The critical processing procedures must be validated and must not render the tissues or cells clinically ineffective or harmful to the recipient • Validation may be based on studies performed by the establishment itself, or on data from published studies or, for well established processing procedures, by retrospective evaluation of the clinical results • It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff • The procedures must be documented in SOPs which must conform to the validated method and to the standards laid down in this Directive

  7. Authorisation of preparation processes2006/86/EC - Annex II – Part B: additional requirements • It must be ensured that all processes are conducted in accordance with the approved SOPs • Where a microbial inactivation procedure is applied to the tissue or cells, it must be specified, documented, and validated • Before implementing any significant change in processing, the modified process must be validated and documented • The processing procedures must undergo regular critical evaluation to ensure that they continue to achieve the intended results • Procedures for discarding tissue and cells must prevent the contamination of other donations and products, the processing environment or personnel

  8. Human Tissue (Quality and Safety for Human Application) Regulations 2007 • The HTA is the Competent Authority in the UK for the EUTCD for tissues and cells, other than gametes and embryos • (HFEA - Competent Authority for gametes & embryos) • EUTCD was transposed into UK Law as the: • Human Tissue (Quality and Safety for Human Application) Regulations 2007

  9. Human Tissue (Quality and Safety for Human Application) Regulations 2007 • Regulation 16 requires that: • in respect of tissue and cell preparation processes, the HTA shall issue directions for securing compliance with the EUTCDs • The process validation requirements of Directive 2006/86/EC were implemented through Directions 003/2010 • Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment (the Guide)

  10. Process validation requirements The Guide – paragraph 126 • Establishments must provide the HTA with evidence that the new cell or tissue preparation process is subject to the quality control measures outlined in paragraphs 25 to 27 and is validated in accordance with the principles set out in paragraphs 128 and 129

  11. Process validation requirements The Guide – paragraphs 127-132 • Critical processing steps must be identified and validated and must not render the tissues or cells clinically ineffective or harmful to the recipient • Validation may be based on studies performed by the establishment itself, or on data from published studies or, for well established processing methods, by retrospective evaluation of the clinical results for tissues supplied by the establishment • It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff

  12. Process validation requirements The Guide – paragraphs 25-27 • The critical quality attributes of the given tissues or cells must be defined and described, as well as the methodologies required to achieve those specifications • Based on these requirements an establishment should identify and document all critical activities • Reagents and material required to achieve or maintain critical quality attributes of tissues and cells must be listed and subject to acceptance controls. All critical equipment should be identified and be subject to controls described in the equipment section • For every critical activity, the materials, equipment and personnel involved must be identified and documented

  13. Authorisation of preparation processes Standard condition 15 of all HA licences • Requires that: • The DI must notify the HTA when new types of tissues or cells are to be procured, tested, processed, stored, distributed, imported or exported by the establishment • The new type of tissues and/or cells may not be processed by the establishment until the HTA is satisfied that the establishment has suitable premises and employs suitable practices to carry out the proposed activity

  14. ATMPs and preparation processes EU guidelines for GMP for medicinal products – Annex 2 • Paragraph 36 states that for human tissues and cells used as starting materials for biological medicinal products: • There may be some instances where processing of cells and tissues used as starting materials for biological medicinal products will be conducted at tissue establishments, e.g. to derive early cell lines or banks prior to establishing a Master Cell Bank (MCB) • Such processing steps, are under the scope of Directive 2004/23/EC

  15. The EUSTITE Project Authorisation of preparation processes and the PPD • In December 2006 the EUSTITE (European Standards and Training in the Inspection of Tissue Establishments) project was launched • 10 EU Member States and the World Health Organisation • Development of guidelines to support EU Member States in the implementation of the regulatory tasks to be carried out to ensure compliance with the EUTCDs. • Authorisation of preparation processes for tissues and cells

  16. The EUSTITE Project Authorisation of preparation processes and the PPD • In 2010, the EC adopted the recommendations of the EUSTITE project, including the authorisation of processing of tissues and cells using a Preparation Process Dossier (PPD) • Competent Authorities, like the HTA, are expected to implement this recommendation • In April 2012, the HTA adopted the PPD for authorisation of all new preparation processes

  17. Useful links • European Parliament and Council Directive 2004/23/EC (Parent Directive) • http://eur-lex.europa.eu/LexUriServ/site/en/oj/2004/l_102/l_10220040407en00480058.pdf • Commission Directive 2006/17/EC (First Technical Directive to Parent Directive) • http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_038/l_03820060209en00400052.pdf • Commission Directive 2006/86/EC (Second Technical Directive to Parent Directive) • http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_294/l_29420061025en00320050.pdf • The Human Tissue (Quality and Safety for Human Application) Regulations 2007 • http://www.legislation.gov.uk/uksi/2007/1523/contents/made • Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment: • http://www.hta.gov.uk/_db/_documents/Annex_-_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_for_Patient_Treatment.pdf • EU guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use • http://ec.europa.eu/health/files/eudralex/vol-4/vol4-an2__2012-06_en.pdf

  18. www.hta.gov.uk http://twitter.com/HTA_UK http://www.Facebook.com/HumanTissueAuthority

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