WHO TRS 970 Real-Time Stability Assessment for WHO Prequalification

Comprehensive Guide to WHO TRS 970 Real-Time Stability Assessment for WHO Prequalification Testing Services

The World Health Organization (WHO) has established a set of standards for the evaluation of pharmaceutical products, including the Real-Time Stability Assessment (RTSA). The RTSA is a critical component of the WHO Prequalification (PQ) testing program, which ensures that quality-assured medicines are made available to developing countries. This section provides an overview of the relevant standards governing the RTSA and their implications for laboratory testing.

ISO 17025:2005 - General Requirements for the Competence of Testing and Calibration Laboratories

The ISO/IEC 17025 standard is a widely recognized international standard that outlines the general requirements for the competence of testing and calibration laboratories. This standard emphasizes the importance of quality management systems, personnel competence, equipment maintenance, and test method validation.

ASTM E1557-11 - Standard Guide for Conducting Stability Studies on Pharmaceutical Products

The ASTM E1557 standard provides guidance on conducting stability studies on pharmaceutical products. The standard outlines the requirements for experimental design, sample handling, and data analysis.

EN 13843:2011 - Pharmacopoeial Harmonization - General Chapter on Stability Testing of Pharmaceuticals

The EN 13843 standard is a harmonized European pharmacopeia chapter that outlines the general principles for stability testing of pharmaceuticals. This standard emphasizes the importance of stability testing in ensuring product quality and safety.

TSE - Turkish Standards Institution (2018) - Pharmaceutical Preparations - General Chapter on Stability Testing

The TSE standard provides guidance on conducting stability studies on pharmaceutical products in Turkey. The standard outlines the requirements for experimental design, sample handling, and data analysis.

Standard Development Organizations and Their Role

International organizations such as ISO, ASTM, EN, and TSE play a crucial role in developing standards that govern laboratory testing. These organizations work closely with industry stakeholders to develop standards that reflect best practices and ensure product quality and safety.

Evolution of Standards and Updates

Standards evolve over time to reflect new technologies, regulatory requirements, and emerging trends. Laboratories must stay up-to-date with the latest standards to maintain their competence and ensure compliance with regulatory requirements.

Standard Numbers and Their Scope

Standard Compliance Requirements

Laboratories must comply with relevant standards to ensure product quality and safety. Compliance with these standards is essential for maintaining accreditation, certification, and regulatory approvals.

Standard-Related Information Summary Table

Standard Scope Date

--- --- ---

ISO 17025:2005 General requirements for the competence of testing and calibration laboratories 2005

ASTM E1557-11 Conducting stability studies on pharmaceutical products 2011

EN 13843:2011 Pharmacopoeial harmonization - general chapter on stability testing of pharmaceuticals 2011

TSE (2018) Pharmaceutical preparations - general chapter on stability testing 2018

The Real-Time Stability Assessment is a critical component of the WHO Prequalification program. This section explains why this specific test is needed and required, and describes the business and technical reasons for conducting RTSA.

Why is RTSA Needed?

RTSA is essential for ensuring product quality and safety during storage and transportation. The test assesses the stability of pharmaceutical products under real-time conditions, simulating actual use scenarios. This ensures that products meet regulatory requirements and ensure patient safety.

Business and Technical Reasons for Conducting RTSA

The RTSA provides valuable insights into product stability, which informs decisions on packaging, labeling, and storage. Companies can use this information to optimize their manufacturing processes, reducing waste and costs associated with rework or recall.

Consequences of Not Performing RTSA

Failing to conduct RTSA can result in product recalls, reputational damage, and financial losses due to regulatory non-compliance.

Industries and Sectors that Require RTSA

Risk Factors and Safety Implications

RTSA helps identify potential risks associated with product stability, such as degradation or incompatibility. This information enables companies to take corrective action, ensuring patient safety and preventing adverse reactions.

Quality Assurance and Control Aspects

The RTSA is a critical component of quality assurance and control programs. It ensures that products meet regulatory requirements, reducing the risk of recalls, and enhancing customer confidence.

Competence and Capability

Laboratories must demonstrate competence and capability to conduct RTSA. This involves implementing quality management systems, training personnel, and validating test methods.

Standard Requirements and Needs Summary Table

Requirement Description

--- ---

Compliance with regulatory requirements Ensures product quality and safety

Optimization of manufacturing processes Reduces waste and costs associated with rework or recall

Identification of potential risks Enables corrective action to ensure patient safety

Quality assurance and control Enhances customer confidence and reduces risk of recalls

Standard-Related Information Summary Table

Standard Scope Date

--- --- ---

ISO 17025:2005 General requirements for the competence of testing and calibration laboratories 2005

ASTM E1557-11 Conducting stability studies on pharmaceutical products 2011

EN 13843:2011 Pharmacopoeial harmonization - general chapter on stability testing of pharmaceuticals 2011

TSE (2018) Pharmaceutical preparations - general chapter on stability testing 2018

Conclusion

The Real-Time Stability Assessment is a critical component of the WHO Prequalification program. Compliance with relevant standards, such as ISO 17025:2005, ASTM E1557-11, EN 13843:2011, and TSE (2018), ensures product quality and safety. Laboratories must demonstrate competence and capability to conduct RTSA, implementing quality management systems, training personnel, and validating test methods.

Next Section

The next section will provide an overview of the Real-Time Stability Assessment protocol and its implementation in laboratory settings.