Tag: validation in pharmaceutics

How to Justify Use of Legacy Equipment to Regulators

How to Justify Use of Legacy Equipment to Regulators How to Justify Use of Legacy Equipment to Regulators In the highly regulated environment of the pharmaceutical industry, validation plays a critical role in ensuring product safety, efficacy, and quality. Legacy…

Integrating CPV Data with Quality Management Review

Integrating CPV Data with Quality Management Review Integrating CPV Data with Quality Management Review In the pharmaceutical industry, validation plays a crucial role in ensuring the safety, efficacy, and quality of products. The integration of Continued Process Verification (CPV) data…

PPQ Protocol Deviations: Documentation and Justification

PPQ Protocol Deviations: Documentation and Justification PPQ Protocol Deviations: Documentation and Justification Protocol deviations during the Process Performance Qualification (PPQ) stage are not uncommon in the pharmaceutical validation lifecycle. Understanding how to document and justify these deviations is imperative for…

PPQ in Multi-Product Facilities: Key Challenges and Controls

PPQ in Multi-Product Facilities: Key Challenges and Controls PPQ in Multi-Product Facilities: Key Challenges and Controls In the realm of pharmaceutical development, proper validation processes are fundamental to ensuring therapeutic efficacy and patient safety. Particularly, the Process Performance Qualification (PPQ)…