Cleaning Validation
Choice of Analytical Techniques for Cleaning Validation
Visual Inspection: Visual Inspection is the examination of the dried equipment under suitable lighting conditions by personnel with appropriate standards of vision. Generally, it is used when it has been demonstrated that a calculated MACO would leave a visible residue as it is not intuitive that a validated method of ... Read More
Bracketing and Worst Case Rating in Cleaning Validation
The cleaning processes of multiple product use equipment in the facilities are subject to requirements for cleaning validation. The validation effort could be huge. In order to minimize the amount of validation required, a worst case approach for the validation can be used. Bracketing ProcedureThe first thing to do is ... Read More
Cleaning Validation Acceptance Criteria Calculation
The cleaning validation acceptance criteria preferably should be based on the Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) calculations whenever this data is available. The APIC Guidance refers primarily to ADE in the examples of calculations included in this chapter, in line with the ISPE recommended calculations. Acceptance ... Read More
APIC Guidance on Aspects of Cleaning Validation in API Plant
This guidance document was published by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC for cleaning validation in active pharmaceutical ingredient manufacturing plants. Six specific areas are addressed in this Guidance document: Acceptance Criteria Companies must demonstrate during cleaning validation that ... Read More
Cleaning Validation in Pharmaceutical Industry
Cleaning validation is a crucial process in the pharmaceutical industry that involves ensuring that equipment and facilities are free of residue and contaminants that could impact product quality and safety. Over the years, different approaches and techniques have been developed and adopted for cleaning validation, each building on the successes ... Read More