Cleaning validation

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Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.[1][2]

[edit] References

  1. ^ Application of total organic carbon analysis to cleaning validation. PDA J Pharm Sci Technol. 1996 Jan-Feb - PubMed Result. www.ncbi.nlm.nih.gov. Retrieved on 2008-03-10.
  2. ^ Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products. cat.inist.fr. Retrieved on 2008-03-10.
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