Considerations for veterinary scientific advice and marketing - - PowerPoint PPT Presentation

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Considerations for veterinary scientific advice and marketing - - PowerPoint PPT Presentation

Jun 04, 2023 14 likes •255 views

Considerations for veterinary scientific advice and marketing authorisations Presented by: Mary OGrady Irish Medicines Board An agency of the European Union Veterinary scientific advice Veterinary marketing authorisations 1

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An agency of the European Union

Considerations for veterinary scientific advice and marketing authorisations

Presented by: Mary O’Grady Irish Medicines Board

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Veterinary scientific advice Veterinary marketing authorisations

Considerations for veterinary scientific advice and marketing authorisations 1

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Scientific Advice applications in 2013

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10 20 30 Pharmaceuticals Immunologicals 'Other' biologicals No of Applications Application type Total requests Quality aspects

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Pharmaceutical or immunological ?

Directive 2009/ 9/ EC

  • Title I

Requirements for veterinary medicinal products other than immunological veterinary medicinal products

  • Title II

Requirements for immunological veterinary medicinal products

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Pharmaceutical or immunological ?

  • Stem cells
  • Monoclonals
  • Cytokines
  • Bacteriophages
  • ‘Medical Device type’ products
  • Other biological molecules

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Scientific Advice - Some issues

  • Setting specifications
  • Quality by Design
  • Sterility
  • Stability
  • Other diverse topics

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Setting specifications

VICH GL39: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances

  • Universal tests
  • Functionality related tests
  • Impurities

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Quality by Design

  • ICH guidelines Q8-Q11
  • Justification of the classification into critical and non-critical
  • Risk assessment
  • Probability √
  • Impact √
  • Detection X
  • Insufficient data
  • Movement within a design space

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Sterility

  • Choice of sterilisation methods
  • European Pharmacopoeia Monographs
  • Follow decision trees EMEA/ CVMP/ 065/ 99
  • For product and components
  • Specific details of criteria for acceptance/ rejection
  • Equipment at production site not a justification

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Stability

  • Bracketing and Matrixing VICH GL 45
  • Use of supporting data from similar products
  • Stability indicating tests
  • Accelerated studies for biologicals VICH GL17

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Other issues

  • Generics – data required to demonstrate pharmaceutical

equivalence of products

  • Quality of atypical active substances
  • Child resistant closures
  • Viral safety strategy
  • TSE

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General Advice

  • Include sufficient information in the data package
  • Brief synopsis of the product and its stage of development
  • Background to the issue
  • Question to be answered must be clearly stated
  • Review Ph. Eur. monographs and human guidelines
  • Quote relevant guidelines
  • Justify any omissions
  • Do not omit the obvious

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Veterinary marketing authorisations

  • Development Pharmaceutics
  • Manufacturing process/ validation
  • Active substance
  • Specifications
  • Specific dosage forms
  • Tablets
  • Parenteral preparations
  • Single dose spot on products

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Use the Development Pharmaceutics Section

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  • To define the target product profile
  • To identify critical quality attributes
  • To determine quality attributes of the starting materials
  • To aid the selection of an appropriate manufacturing process
  • To identify a control strategy
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Manufacturing process/ validation

New process validation guideline – effective August 2014 EMA/ CHMP/ CVMP/ QWP/ 70278/ 2012-Rev 1 ‘Guideline on process validation for finished products -information and data to be provided in regulatory submissions’

  • Traditional process validation
  • Continuous process verification
  • Standard vs Non-standard processes

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Active substance

  • Starting materials
  • GMP declarations
  • Use of CEP’s

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Specifications

Specifications should:

  • assure suitability for intended purpose
  • assure animal safety
  • reflect state of knowledge/ development
  • reflect capability of technology & process

As development proceeds, specifications should evolve.

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Specifications

Specifications should be based upon the total database of relevant development information. Development data should guide:

  • Selection of tests included in specification
  • Justification for not including certain tests
  • Appropriateness of analytical procedure
  • Justification of acceptance criteria

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Specifications – Impurities

  • Consider likely impurities present
  • Determine content of each known impurity
  • Identify and specify specifically toxic impurities
  • Any unidentified impurities above ID threshold
  • Qualification of impurities
  • Acceptance criterion = Qualified level
  • Any increase in impurity

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Tablets – common issues

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  • Particle size
  • Subdivision of tablets (halves/ quarters)
  • Shelf-life of half tablets
  • Uniformity of dosage units
  • Use of the term “chewable”
  • Use of the term “flavoured”
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Parenteral preparations – common issues

  • Preservative efficacy testing
  • In-use shelf life
  • Self-sealing/ fragmentation

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Spot on Products – common issues

EMEA/ CVMP/ QW P/ 5 4 4 4 6 1 / 2 0 0 7 “Guideline on the Quality Aspects of Single Dose Veterinary Spot-On Products”

  • Determine the residual volume of product in the pipette after the

expression of the dose. This information should then be used to specify fill volume limits during the manufacturing process

  • Express assay in terms of the quantity by mass of the active

substance in a container of average delivered mass or volume. Limits of 95 – 105 % of the declared content should be applied to this parameter.

  • Uniformity of dosage units (Ph. Eur. 2.9.40)

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Familiarise yourself with

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EU Directives, Regulations, National Law

Ph.Eur. Monographs, General Monographs and Chapters

National Compendia

EMA + VI CH Quality Guidelines

Other EMA Documents e.g.Q&A’s PAT Q&A’s

Human Guidelines

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Thank you for your attention!