Swabbing surface area - -Cleaning Validation

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear All,

please suggest on the practices followed for cleaning validation swabbing techniques for solid dosage forms…

  1. surface area swabbed eg. 4 sq inch , 100 cm2 etc… (reference guideline)

  2. Unit for Surface area of equipments taken for calculation (for eg… mm, cm, inches…)

  3. What is to be done incase the acceptance criteria is below the LOD by HPLC provided by QC.

  4. How do we correlate the QC limits and established acceptance criteria.

thanks,

santosh