Tag: iq oq pq training

Regulatory Expectations for Raw Material Qualification Files

Regulatory Expectations for Raw Material Qualification Files Regulatory Expectations for Raw Material Qualification Files Step 1: User Requirements Specification (URS) and Risk Assessment The initial phase in the validation lifecycle involves the development of the User Requirements Specification (URS), which…

Establishing Subjectivity Thresholds in Visual Cleanliness Checks

Establishing Subjectivity Thresholds in Visual Cleanliness Checks Establishing Subjectivity Thresholds in Visual Cleanliness Checks In the pharmaceutical industry, the validation of cleaning processes is critical to ensuring that equipment does not introduce contamination into products. Establishing subjectivity thresholds in visual…