WHO Good Storage and Distribution Practices for Stability

Comprehensive Guide to WHO Good Storage and Distribution Practices for Stability Laboratory Testing Service Provided by Eurolab

WHO Good Storage and Distribution Practices for Stability testing is governed by a range of international and national standards, which ensure the quality and reliability of laboratory tests. These standards are developed and maintained by organizations such as ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Committee for Standardization), TSE (Turkish Standards Institution), and others.

ISO/IEC 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories

This standard is a cornerstone of laboratory testing, providing requirements for competence, impartiality, and quality management. It applies to laboratories that perform testing and calibration in various fields, including pharmaceuticals, biotechnology, and food safety.

ISO 17025:2017 Key Requirements

1. Organization: The laboratory must have a clear organizational structure and define roles and responsibilities.

2. Quality Management System (QMS): A QMS must be implemented to ensure consistent and reliable testing results.

3. Equipment and Calibration: All equipment used for testing must be calibrated, maintained, and verified regularly.

4. Personnel: Laboratory personnel must have the necessary education, training, and experience to perform their tasks.

5. Testing and Calibration Methods: Laboratories must use standardized methods and procedures for testing and calibration.

ASTM E2500-18 - Standard Guide for Establishing Consistency between Laboratory Testing and Code Compliance

This standard provides guidance on ensuring consistency between laboratory testing and code compliance in various industries, including construction and infrastructure.

ASTM E2500-18 Key Requirements

1. Testing Scope: Laboratories must clearly define the scope of their testing services.

2. Testing Methods: Laboratories must use standardized methods and procedures for testing.

3. Quality Assurance: Laboratories must have a quality assurance program in place to ensure consistent results.

4. Compliance: Laboratories must demonstrate compliance with relevant codes and regulations.

EN ISO 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories

This standard is an adaptation of ISO/IEC 17025:2017, providing similar requirements for testing and calibration laboratories in Europe.

TSE NTC 1412-2016 - Pharmaceutical Products - Stability Testing

This Turkish standard provides specific requirements for stability testing of pharmaceutical products, ensuring the quality and reliability of laboratory tests.

International and National Standards Overview

Standard Title

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ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

ASTM E2500-18 Standard Guide for Establishing Consistency between Laboratory Testing and Code Compliance

EN ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

TSE NTC 1412-2016 Pharmaceutical Products - Stability Testing

Standard Development Organizations (SDOs)

SDOs play a crucial role in developing, maintaining, and updating standards. These organizations include:

Standards Evolution and Updates

Standards are regularly reviewed and updated to reflect changes in technology, regulations, and industry practices. Laboratories must stay informed about updates to relevant standards.

Standard Numbers and Scope

Standard Title Scope

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ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories Applies to laboratories that perform testing and calibration in various fields.

ASTM E2500-18 Standard Guide for Establishing Consistency between Laboratory Testing and Code Compliance Applies to laboratories that perform testing and calibration in construction and infrastructure industries.

EN ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories Applies to laboratories that perform testing and calibration in Europe.

TSE NTC 1412-2016 Pharmaceutical Products - Stability Testing Applies to pharmaceutical products stability testing in Turkey.

Standard Compliance Requirements

Laboratories must comply with relevant standards, which may include:

Standard-related Costs

Laboratories must factor in the costs associated with complying with standards, including:

Conclusion

WHO Good Storage and Distribution Practices for Stability laboratory testing is governed by a range of international and national standards. Laboratories must comply with these standards to ensure the quality and reliability of their tests. Eurolab provides laboratory testing services that meet or exceed relevant standards, ensuring the highest level of accuracy and precision.

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