VALIDATION OF STERILE PACKAGE INTEGRITY 1
Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may…
Category: Validation
CALCULATION OF LIMIT BASED ON TOXICITY CLEANING VALIDATION
This method of calculation is based on the use of animal toxicity data to determine limits. As mentioned earlier, this method is particularly suited for…
PROCESS VALIDATION: GENERAL PRINCIPLES AND PRACTICES
General Considerations for Process Validation: – In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make…
ANALYTICAL INSTRUMENT QUALIFICATION (AIQ) 1
AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to…
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