Dennis Jenke

Compatibility of Pharmaceutical Solutions and Contact Materials (eBook, PDF)

Safety Assessments of Extractables and Leachables for Pharmaceutical Products

• Format: PDF

Produktbeschreibung

Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: * Pertinent regulations and practical ways to meet guidelines * Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development * Materials characterization and the materials screening process * Component and/or system qualification (illustrated by several case studies) * Performing validation/migration studies and interpreting and reporting the results * Creating a product registration dossier and putting it through regulatory review * Product maintenance (Change Control) from an extractables and leachables perspective * Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 400
• Erscheinungstermin: 28. Mai 2009
• Englisch
• ISBN-13: 9780470459409
• Artikelnr.: 37292329

Autorenporträt

DENNIS JENKE is Principal Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. He works with a team of analytical chemistry professionals in areas including the assessment of material/product compatibility, specifically with respect to leachables/extractables and product ingredient binding. He has published extensively in the areas of analytical chemistry, environmental science, and material/solution compatibility; serves as an expert reviewer for numerous pharmaceutical and analytical journals; is a frequently invited speaker in the general areas of analytical chemistry and material/solution compatibility; and is currently an active participant in ongoing collaborative activities designed to establish harmonized best demonstrated practices for extractables/leachables assessment.

Inhaltsangabe

PREFACE AND ACKNOWLEDGMENTS. PART A GENERAL CONCEPTS. 1. Introduction.
General Discussion. Key Definitions. The Interacting Parties. Extractables
versus Leachables. Regulatory Perspectives for Performing Compatibility
and/or Safety Assessments. The U.S. Food and Drug Administration Guidance
for Industry: Container Closure Systems for Packaging Human Drugs and
Biologics. European Medicines Agency (EMEA) Guideline on Plastic Immediate
Packaging Materials. FDA Guidance for Industry, Inhalation Products.
Medical Devices. An Overview of Strategies for Performing Safety
Assessments. The Generalized Strategy for Safety Assessments. Moving
Forward. References. 2. Nomenclature and General Concepts. General.
Nomenclature. Primary Definitions. Constituents of a Material or Construct.
Classification of Extracting Media. Classification of Extraction
Strategies. Example Extraction Conditions Applied to a Model System.
Correlation. Factors That Influence the Linking of Extractables and
Leachables. A Hierarchy for Linkages between Extractables and Leachables.
Decisions Concerning the Required Rigor for Linkages. Circumstances
Requiring the Linking of Extractables and Leachables. Identification and
Quantitation. Risks and Risk Management. Risk Categories Related to
Biological Assessment of Medical Devices. Risk Categories Related to
Assessment of Primary Packaging and/or Container-Closure Systems. The
General Dimensions of Risk. Utilization of Risk Classification Profiles.
Risk Classification in Indirect Contact Situations. The Construct Itself as
a Contributor to Risk. References. 3. Extractables, Leachables, and the
Product Life Cycle. General. Discussion of the Components of the Master
Flow Diagram. Observations. Application of the Process Map. PART B MATERIAL
CHARACTERIZATION. 4. Material Screening and Characterization. Overview.
General Principles. Compendial Compliance. United States Pharmacopeia.
Japanese Pharmaceopeia. European Pharmacopeia. Compositional
Characterization, General Concepts. Compositional Characterization by
Collecting Available Material Information. General. Collecting Extractables
Information from the Material Supplier. Compositional Characterization by
Material Testing, Extractables Survey. Extractables Survey: Extraction.
Case Studies: The Influence of Extraction Medium on the Extractables
Survey. Extractables Survey: Extract Analysis. Case Study: Extractables
Survey for Plastic Tubing Materials. Case Study: Extractables Survey for an
Elastomer Used in OINDP. Case Study: Extractables Survey for a Rubber
Closure Used with Semisolid Drug Products. Case Study: Extractables Survey
for Filter Cartridges Used in Downstream Processing of Pharmaceuticals.
Bibliography of Analytical Methods. Reconciliation as a Survey Tool. Case
Study: TOC Reconciliation; Characterization of a Polyolefin Material. Use
of Extractables Information in Safety Assessment: Extractables Profile,
Total Pool, and Total Available Pool. Extractions to Establish the Total
Pool and Total Available Pool. Case Study: Total Pool Determination by
Successive Extraction. Recap: Components of a Complete Extractables
Assessment. Caveats in Using Extractables Information for Safety
Assessment. Chemical Characterization: Device Perspective per ISO 10993-18.
References. PART C CONSTRUCT QUALIFICATION. 5. The Prototype Stage. General
Comments. The Simulation Study. Generating the Simulating Extract.
Simulating the Contact Parameters. Simulating the Therapeutic Product.
Simulating the Exposure Parameters. Analyzing the Simulating Extract. Case
Study: Modeling of the Impact of Solubilizing Agents on Leachables
Accumulation. Case Study: Accumulation of Organic Leachables from Plastic
Biopharmaceutical Process Containers. Case Study: Accumulation of
Label-Related Leachables in a Solid Dosage Form. Case Study: Accumulation
of Caprolactam Oligomers Leached from Nylon-6 Material. Application of the
Analytical Threshold. The Preliminary Toxicological Assessment. Case Study:
Assessment of Cyclohexanone Limits for Containers. Exiting the Prototype
Stage. References. 6. The Early Development Stage. General Comments. Target
Leachables. Method Development, Evaluation, and Validation. Method
Development (Optimization). Prerequisites to Method Optimization. Overview
of the Method Optimization Process. Conduct of a Method Optimization Study.
Primary Performance Assessment. Troubleshooting Guide. Secondary
Performance Assessment. System Suitability. Robustness. Exiting Method
Development-Optimization. The Method Evaluation Process. General. Aspects
of the Evaluation and Validation Processes. Overview of the Method
Evaluation Process. Template for the Conduct of a Method Evaluation Study.
Validation. Case Study: Validation of an LC/MS Method for the Quantitation
of Leachables from a Packaging System. General. Experimental. Validation
Study. Case Study: Validation of an HPLC Method For Quantitating Stopper
Leachables in a Complex Surfactant Vehicle. General. Validation. Exiting
the Early Development Stage. References. PART D CONSTRUCT VALIDATION. 7.
Late Stage Product Development. General: The Migration Study. Design of the
Migration Study. EMEA Guideline on Plastic Immediate Packaging Materials.
FDA Guidance. Optimal Design of a Migration Study. Interpretation of the
Migration Study: Toxicological Assessment. Disaster Management. Class A
Disaster: Unusual or Unexpected Change in the Concentration of a Target
Leachable. Class B Disaster: A Previously Unobserved Response Is Obtained
During Testing. Documenting a Disaster Investigation. Specificity Check in
Drug Product Analysis Methods. Product Stability Issues Associated with
Leachables. References. 8. Submission. General Discussion. Dossier Format:
The Common Technical Document. Contents of the CTD Sections Relevant to
Container Closure Systems and Their Safety Assessment. Section 3.2.P.7,
Description. Section 3.2.P.2.4, Suitability. Closing Observations.
References. 9. Launch. PART E PRODUCT MAINTENANCE. 10. Product Maintenance.
General Discussion. Ongoing Quality Control. General. Incoming Raw
Materials. Manufactured In-Process Goods. Finished Goods (Final Product).
Process of Developing-Implementing QC Extractables Specifications. Change
Control. General. Change Control Impact Assessment. Evaluation
Recommendation. Factors to Consider When Contemplating Changes to
Registered Products. Case Study: Differential Approach. Overview. General
Test Strategy. Experimental. Results and Discussion. Principles for Judging
Toxicological Equivalency. Disaster Management During Product Maintenance.
Atypical Manufacturing During Product Maintenance. Product Use Field Issues
Encountered During Product Maintenance. Changes in Product Registration
Requirements During Product Maintenance. Exiting the Product Maintenance
Stage. References. 11. Retirement. 12. Focus on Emerging Concepts.
Overview. Plastic Materials used in Manufacturing Applications. General.
Regulatory Requirements. Industry Recommendations. Case Study: Leachables
Evaluation for Bulk Drug Substance. Process for Performing Extractables and
Leachables Assessments for Disposable Materials Used in Bioprocessing. A
Matter of Semantics. Best Demonstrated Practices in Extractables
Assessments. The Broader Context of Suitability for Use. An Important
Practical Consideration. Future Considerations. References. Appendix:
Materials Used in Pharmaceutical Constructs and Their Associated
Extractables. References. Index.