Compatibility of Pharmaceutical Solutions and Contact Materials

Name: Compatibility of Pharmaceutical Solutions and Contact Materials | Safety Assessments of Extractables and Leachables for Pharmaceutical Products
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Safety Assessments of Extractables and Leachables for Pharmaceutical Products

Dennis Jenke(Autor*in)

Wiley (Verlag)

Erschienen am 28. Mai 2009

400 Seiten

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Beschreibung

Compatibility of Pharmaceutical Products and Contact Materials
Dennis Jenke
Important safety aspects of compatibility for therapeuticproducts and their manufacturing systems, delivery devices, andcontainers
Compatibility of Pharmaceutical Products and ContactMaterials helps pharmaceutical, toxicology, analytical, andregulatory affairs professionals assess the safety of leachable andextractable chemicals associated with drug product packaging,manufacturing systems, and devices. The most comprehensive resourceavailable, its coverage includes the strategies, tactics, andregulatory requirements for performing safety assessments, alongwith the means for interpreting results.
Structured around a logical framework for an extractables andleachables safety assessment and closely linked to thepharmaceutical product development process, Compatibility ofPharmaceutical Products and Contact Materials directlyaddresses the fundamental questions of "what activities need to beperformed to completely, efficiently, and effectively address theissue of product safety from an extractables and leachablesperspective?" and "when do the various required activities need tobe performed?" Specifically, the chapters describe:
* Pertinent regulations and practical ways to meetguidelines
* Coordinating manufacturing, storage, and delivery systemsdevelopment and qualification with therapeutic productdevelopment
* Materials characterization and the materials screeningprocess
* Component and/or system qualification (illustrated by severalcase studies)
* Performing validation/migration studies and interpreting andreporting the results
* Creating a product registration dossier and putting it throughregulatory review
* Product maintenance (Change Control) from an extractables andleachables perspective
* Likely future developments in extractables and leachablesassessment
Additionally, the book's appendix provides a database, includingCAS registry numbers, chemical formulas and molecular weights ofextractable/leachable substances that have been reported in thechemical literature.
Detailing the interconnected roles played by analyticalchemistry, biological science, toxicology, and regulatory science,Compatibility of Pharmaceutical Products and ContactMaterials supplies a much-needed, comprehensive resource to allthose in pharmaceutical product or medical device development.

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Inhalt

1 - COMPATIBILITY OF PHARMACEUTICAL PRODUCTS AND CONTACT MATERIALS [Seite 3]
1.1 - CONTENTS [Seite 9]
1.2 - PREFACE AND ACKNOWLEDGMENTS [Seite 17]
1.3 - PART A GENERAL CONCEPTS [Seite 23]
1.3.1 - 1. Introduction [Seite 25]
1.3.1.1 - General Discussion [Seite 25]
1.3.1.2 - Key Definitions [Seite 28]
1.3.1.2.1 - The Interacting Parties [Seite 28]
1.3.1.2.2 - Extractables versus Leachables [Seite 29]
1.3.1.3 - Regulatory Perspectives for Performing Compatibility and/or Safety Assessments [Seite 35]
1.3.1.3.1 - The U.S. Food and Drug Administration Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics [Seite 36]
1.3.1.3.2 - European Medicines Agency (EMEA) Guideline on Plastic Immediate Packaging Materials [Seite 37]
1.3.1.3.3 - FDA Guidance for Industry, Inhalation Products [Seite 40]
1.3.1.3.4 - Medical Devices [Seite 42]
1.3.1.4 - An Overview of Strategies for Performing Safety Assessments [Seite 43]
1.3.1.5 - The Generalized Strategy for Safety Assessments [Seite 44]
1.3.1.6 - Moving Forward [Seite 46]
1.3.1.7 - References [Seite 47]
1.3.2 - 2. Nomenclature and General Concepts [Seite 49]
1.3.2.1 - General [Seite 49]
1.3.2.2 - Nomenclature [Seite 49]
1.3.2.2.1 - Primary Definitions [Seite 50]
1.3.2.2.2 - Constituents of a Material or Construct [Seite 51]
1.3.2.2.3 - Classification of Extracting Media [Seite 53]
1.3.2.2.4 - Classification of Extraction Strategies [Seite 54]
1.3.2.2.5 - Example Extraction Conditions Applied to a Model System [Seite 61]
1.3.2.3 - Correlation [Seite 65]
1.3.2.3.1 - Factors That Influence the Linking of Extractables and Leachables [Seite 66]
1.3.2.3.2 - A Hierarchy for Linkages between Extractables and Leachables [Seite 66]
1.3.2.3.3 - Decisions Concerning the Required Rigor for Linkages [Seite 69]
1.3.2.3.4 - Circumstances Requiring the Linking of Extractables and Leachables [Seite 70]
1.3.2.4 - Identification and Quantitation [Seite 72]
1.3.2.5 - Risks and Risk Management [Seite 77]
1.3.2.5.1 - Risk Categories Related to Biological Assessment of Medical Devices [Seite 80]
1.3.2.5.2 - Risk Categories Related to Assessment of Primary Packaging and/or Container-Closure Systems [Seite 80]
1.3.2.5.3 - The General Dimensions of Risk [Seite 86]
1.3.2.5.4 - Utilization of Risk Classification Profiles [Seite 90]
1.3.2.5.5 - Risk Classification in Indirect Contact Situations [Seite 93]
1.3.2.5.6 - The Construct Itself as a Contributor to Risk [Seite 95]
1.3.2.6 - References [Seite 96]
1.3.3 - 3. Extractables, Leachables, and the Product Life Cycle [Seite 99]
1.3.3.1 - General [Seite 99]
1.3.3.2 - Discussion of the Components of the Master Flow Diagram [Seite 100]
1.3.3.3 - Observations [Seite 105]
1.3.3.4 - Application of the Process Map [Seite 109]
1.4 - PART B MATERIAL CHARACTERIZATION [Seite 111]
1.4.1 - 4. Material Screening and Characterization [Seite 113]
1.4.1.1 - Overview [Seite 113]
1.4.1.2 - General Principles [Seite 116]
1.4.1.3 - Compendial Compliance [Seite 119]
1.4.1.3.1 - United States Pharmacopeia [Seite 120]
1.4.1.3.2 - Japanese Pharmaceopeia [Seite 123]
1.4.1.3.3 - European Pharmacopeia [Seite 124]
1.4.1.4 - Compositional Characterization, General Concepts [Seite 125]
1.4.1.5 - Compositional Characterization by Collecting Available Material Information [Seite 126]
1.4.1.5.1 - General [Seite 126]
1.4.1.5.2 - Collecting Extractables Information from the Material Supplier [Seite 128]
1.4.1.6 - Compositional Characterization by Material Testing, Extractables Survey [Seite 134]
1.4.1.6.1 - Extractables Survey: Extraction [Seite 134]
1.4.1.6.2 - Case Studies: The Influence of Extraction Medium on the Extractables Survey [Seite 143]
1.4.1.6.3 - Extractables Survey: Extract Analysis [Seite 146]
1.4.1.6.4 - Case Study: Extractables Survey for Plastic Tubing Materials [Seite 153]
1.4.1.6.5 - Case Study: Extractables Survey for an Elastomer Used in OINDP [Seite 158]
1.4.1.6.6 - Case Study: Extractables Survey for a Rubber Closure Used with Semisolid Drug Products [Seite 159]
1.4.1.6.7 - Case Study: Extractables Survey for Filter Cartridges Used in Downstream Processing of Pharmaceuticals [Seite 160]
1.4.1.6.8 - Bibliography of Analytical Methods [Seite 161]
1.4.1.6.9 - Reconciliation as a Survey Tool [Seite 162]
1.4.1.6.10 - Case Study: TOC Reconciliation [Seite 163]
1.4.1.7 - Use of Extractables Information in Safety Assessment: Extractables Profile, Total Pool, and Total Available Pool [Seite 164]
1.4.1.7.1 - Extractions to Establish the Total Pool and Total Available Pool [Seite 165]
1.4.1.7.2 - Case Study: Total Pool Determination by Successive Extraction [Seite 167]
1.4.1.8 - Recap: Components of a Complete Extractables Assessment [Seite 168]
1.4.1.9 - Caveats in Using Extractables Information for Safety Assessment [Seite 171]
1.4.1.10 - Chemical Characterization: Device Perspective per ISO 10993-18 [Seite 174]
1.4.1.11 - References [Seite 176]
1.5 - PART C CONSTRUCT QUALIFICATION [Seite 179]
1.5.1 - 5. The Prototype Stage [Seite 181]
1.5.1.1 - General Comments [Seite 181]
1.5.1.2 - The Simulation Study [Seite 183]
1.5.1.2.1 - Generating the Simulating Extract [Seite 184]
1.5.1.2.2 - Simulating the Contact Parameters [Seite 186]
1.5.1.2.3 - Simulating the Therapeutic Product [Seite 188]
1.5.1.2.4 - Simulating the Exposure Parameters [Seite 191]
1.5.1.2.5 - Analyzing the Simulating Extract [Seite 193]
1.5.1.2.6 - Case Study: Modeling of the Impact of Solubilizing Agents on Leachables Accumulation [Seite 194]
1.5.1.2.7 - Case Study: Accumulation of Organic Leachables from Plastic Biopharmaceutical Process Containers [Seite 196]
1.5.1.2.8 - Case Study: Accumulation of Label-Related Leachables in a Solid Dosage Form [Seite 201]
1.5.1.2.9 - Case Study: Accumulation of Caprolactam Oligomers Leached from Nylon-6 Material [Seite 202]
1.5.1.2.10 - Application of the Analytical Threshold [Seite 203]
1.5.1.3 - The Preliminary Toxicological Assessment [Seite 206]
1.5.1.3.1 - Case Study: Assessment of Cyclohexanone Limits for Containers [Seite 210]
1.5.1.4 - Exiting the Prototype Stage [Seite 210]
1.5.1.5 - References [Seite 211]
1.5.2 - 6. The Early Development Stage [Seite 213]
1.5.2.1 - General Comments [Seite 213]
1.5.2.2 - Target Leachables [Seite 214]
1.5.2.3 - Method Development, Evaluation, and Validation [Seite 216]
1.5.2.3.1 - Method Development (Optimization) [Seite 217]
1.5.2.3.2 - Prerequisites to Method Optimization [Seite 217]
1.5.2.3.3 - Overview of the Method Optimization Process [Seite 219]
1.5.2.3.4 - Conduct of a Method Optimization Study [Seite 222]
1.5.2.3.5 - Primary Performance Assessment [Seite 223]
1.5.2.3.6 - Troubleshooting Guide [Seite 224]
1.5.2.3.7 - Secondary Performance Assessment [Seite 226]
1.5.2.3.8 - System Suitability [Seite 227]
1.5.2.3.9 - Robustness [Seite 227]
1.5.2.3.10 - Exiting Method Development-Optimization [Seite 228]
1.5.2.4 - The Method Evaluation Process [Seite 228]
1.5.2.4.1 - General [Seite 228]
1.5.2.4.2 - Aspects of the Evaluation and Validation Processes [Seite 229]
1.5.2.4.3 - Overview of the Method Evaluation Process [Seite 229]
1.5.2.4.4 - Template for the Conduct of a Method Evaluation Study [Seite 231]
1.5.2.5 - Validation [Seite 236]
1.5.2.6 - Case Study: Validation of an LC/MS Method for the Quantitation of Leachables from a Packaging System [Seite 237]
1.5.2.6.1 - General [Seite 237]
1.5.2.6.2 - Experimental [Seite 238]
1.5.2.6.3 - Validation Study [Seite 240]
1.5.2.7 - Case Study: Validation of an HPLC Method For Quantitating Stopper Leachables in a Complex Surfactant Vehicle [Seite 247]
1.5.2.7.1 - General [Seite 247]
1.5.2.7.2 - Validation [Seite 247]
1.5.2.8 - Exiting the Early Development Stage [Seite 250]
1.5.2.9 - References [Seite 250]
1.6 - PART D CONSTRUCT VALIDATION [Seite 251]
1.6.1 - 7. Late Stage Product Development [Seite 253]
1.6.1.1 - General: The Migration Study [Seite 253]
1.6.1.2 - Design of the Migration Study [Seite 255]
1.6.1.2.1 - EMEA Guideline on Plastic Immediate Packaging Materials [Seite 255]
1.6.1.2.2 - FDA Guidance [Seite 255]
1.6.1.2.3 - Optimal Design of a Migration Study [Seite 256]
1.6.1.3 - Interpretation of the Migration Study: Toxicological Assessment [Seite 260]
1.6.1.4 - Disaster Management [Seite 260]
1.6.1.4.1 - Class A Disaster: Unusual or Unexpected Change in the Concentration of a Target Leachable [Seite 261]
1.6.1.4.2 - Class B Disaster: A Previously Unobserved Response Is Obtained During Testing [Seite 263]
1.6.1.4.3 - Documenting a Disaster Investigation [Seite 264]
1.6.1.5 - Specificity Check in Drug Product Analysis Methods [Seite 264]
1.6.1.6 - Product Stability Issues Associated with Leachables [Seite 266]
1.6.1.7 - References [Seite 267]
1.6.2 - 8. Submission [Seite 271]
1.6.2.1 - General Discussion [Seite 271]
1.6.2.2 - Dossier Format: The Common Technical Document [Seite 272]
1.6.2.3 - Contents of the CTD Sections Relevant to Container Closure Systems and Their Safety Assessment [Seite 274]
1.6.2.3.1 - Section 3.2.P.7, Description [Seite 274]
1.6.2.3.2 - Section 3.2.P.2.4, Suitability [Seite 276]
1.6.2.4 - Closing Observations [Seite 284]
1.6.2.5 - References [Seite 285]
1.6.3 - 9. Launch [Seite 287]
1.7 - PART E PRODUCT MAINTENANCE [Seite 293]
1.7.1 - 10. Product Maintenance [Seite 295]
1.7.1.1 - General Discussion [Seite 295]
1.7.1.2 - Ongoing Quality Control [Seite 297]
1.7.1.2.1 - General [Seite 297]
1.7.1.2.2 - Incoming Raw Materials [Seite 297]
1.7.1.2.3 - Manufactured In-Process Goods [Seite 300]
1.7.1.2.4 - Finished Goods (Final Product) [Seite 301]
1.7.1.2.5 - Process of Developing-Implementing QC Extractables Specifications [Seite 303]
1.7.1.3 - Change Control [Seite 304]
1.7.1.3.1 - General [Seite 304]
1.7.1.3.2 - Change Control Impact Assessment [Seite 307]
1.7.1.3.3 - Evaluation Recommendation [Seite 317]
1.7.1.3.4 - Factors to Consider When Contemplating Changes to Registered Products [Seite 318]
1.7.1.4 - Case Study: Differential Approach [Seite 319]
1.7.1.4.1 - Overview [Seite 319]
1.7.1.4.2 - General Test Strategy [Seite 319]
1.7.1.4.3 - Experimental [Seite 320]
1.7.1.4.4 - Results and Discussion [Seite 321]
1.7.1.5 - Principles for Judging Toxicological Equivalency [Seite 326]
1.7.1.6 - Disaster Management During Product Maintenance [Seite 327]
1.7.1.6.1 - Atypical Manufacturing During Product Maintenance [Seite 327]
1.7.1.6.2 - Product Use Field Issues Encountered During Product Maintenance [Seite 331]
1.7.1.7 - Changes in Product Registration Requirements During Product Maintenance [Seite 334]
1.7.1.8 - Exiting the Product Maintenance Stage [Seite 335]
1.7.1.9 - References [Seite 335]
1.7.2 - 11. Retirement [Seite 337]
1.7.3 - 12. Focus on Emerging Concepts [Seite 341]
1.7.3.1 - Overview [Seite 341]
1.7.3.2 - Plastic Materials used in Manufacturing Applications [Seite 342]
1.7.3.2.1 - General [Seite 342]
1.7.3.2.2 - Regulatory Requirements [Seite 343]
1.7.3.2.3 - Industry Recommendations [Seite 344]
1.7.3.2.4 - Case Study: Leachables Evaluation for Bulk Drug Substance [Seite 348]
1.7.3.2.5 - Process for Performing Extractables and Leachables Assessments for Disposable Materials Used in Bioprocessing [Seite 349]
1.7.3.2.6 - A Matter of Semantics [Seite 350]
1.7.3.3 - Best Demonstrated Practices in Extractables Assessments [Seite 353]
1.7.3.4 - The Broader Context of Suitability for Use [Seite 359]
1.7.3.5 - An Important Practical Consideration [Seite 362]
1.7.3.6 - Future Considerations [Seite 364]
1.7.3.7 - References [Seite 366]
1.8 - Appendix: Materials Used in Pharmaceutical Constructs and Their Associated Extractables [Seite 369]
1.8.1 - References [Seite 392]
1.9 - INDEX [Seite 393]

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