Reliability Standards for Testing in Domestic and Overseas Contracting (Testing/Manufacturing) and Quality Management in Contract Manufacturing and Supplier Audits

¥62 ,500

This publication addresses the reliability standards for testing in both domestic and international contract manufacturing, focusing on quality management and supplier audits. It provides insights into compliance with regulatory requirements and best practices for ensuring data reliability and quality in the context of contract testing and manufacturing.

This is a request, not an immediate purchase. Your card is authorized but not charged. Delivery takes about one week. We capture payment when the English PDF is ready.

SKU: 1182 Category: Tags: , , , , ,

Description

This is a request, not an immediate purchase. Delivery takes about one week. Your card is authorized but not charged until the English PDF is ready.

Product ID: 1182

Publisher: Science & Technology

Publication Date: 2026-06-19

English Summary

This publication addresses the reliability standards for testing in both domestic and international contract manufacturing, focusing on quality management and supplier audits. It provides insights into compliance with regulatory requirements and best practices for ensuring data reliability and quality in the context of contract testing and manufacturing.

Contents / Coverage

  • Chapter 1: Compliance Document Review for Quality Testing and Non-Clinical Trials at PMDA
  • Chapter 2: Ensuring Data Reliability and Handling Based on Differences Between Domestic and International Standards
  • Chapter 3: Considerations and Equivalence Evaluation During Technical Transfer of Analytical Testing Methods
  • Chapter 4: Points to Consider in Regulatory Consultation and Preparation of Approval Application Documents for Overseas Introduced Biologics
  • Chapter 5: Ensuring Reliability and Case Studies for Utilizing Academic Data in Applications
  • Chapter 6: Considerations for Conducting Contract Testing in Biopharmaceuticals
  • Chapter 1: Key Points to Consider When Selecting Contract Manufacturers (Considering Overseas)
  • Chapter 2: Quality Risk Management in Contract Manufacturing
  • Chapter 3: Audit and Evaluation Methods for Contract Manufacturing Based on a Risk-Based Approach
  • Chapter 4: Responses to Changes and Deviations in Contract Manufacturing
  • Chapter 5: Raw Material Management at Contract Manufacturing Sites
  • Chapter 6: Actual Trouble Cases in Contract Manufacturing
  • Chapter 7: Key Points for Quality Management and Risk Management in Supplier Audits (non-GMP)
  • Chapter 8: Considerations for Contract Manufacturing in Biopharmaceuticals

Why This May Matter Internationally

The book is relevant for professionals involved in contract testing and manufacturing across borders, particularly in the pharmaceutical and biotechnology sectors. It discusses the nuances of regulatory compliance and quality assurance that are critical for global operations.

Keywords: Japan,technical book,Science & Technology,contract manufacturing,quality management,supplier audits

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