Autoclave Validation Risk: Uneven temperature distribution could lead to incomplete sterilization. QRM Application: Conduct risk assessments for load configurations and identify critical spots for temperature sensors to ensure uniform heat distribution. Cold Chain Validation Risk: Temperature excursions during storage or transport might compromise product quality. QRM Application: Use risk-based mapping to monitor high-risk areas (e.g.,…
Pharmaceutical microbiology plays a critical role in ensuring the quality and safety of pharmaceutical products. Microorganisms can contaminate products, potentially harming patients and compromising product efficacy. Therefore, controlling and preventing contamination is essential to ensure product safety and this can be achieved through the process of Risk Assessment.Risk assessment is a systematic process that identifies,…
The main steps involved in the Corrective and Preventive Action (CAPA) process: 1. Identification: The first step is to identify the issue or non-conformance that needs to be addressed. This can be done through various means, such as audits, inspections, customer complaints, or internal quality control. 2. Evaluation: Once the issue is identified, it’s…
