Cleaning validation for API plant

Pl.sir Send me formate for cleaning validation in my API’s plant i want to apply for GMP certifications.


hemang joshi

Dear Mr. Hemang,

I think you cannot get any format for cleaning validation (in API manufacturing) here on this forum. I have few recommendations for you (use them to understand and perform cleaning validation):


  • CEFIC - Active Pharmaceutical Ingredients Committee (APIC), [b]Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants[/b], (CEFIC, Brussels, December 2000), available at .
  • “[b]Points to Consider for Cleaning Validation[/b]–Technical Report No. 29,” PDA J. Pharm. Sci. Technol. 52 (6), 1–23 (1998).

    Hope these references might be some use. Please let me know if you are looking for something specific.