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Cleaning Validation : Defining Limits and Doing MACO ...

Cleaning Validation : Defining Limits and Doing MACO ...

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Residue and LimitsLimits and acceptance criteria should be : • Practical • Verifiable • Achievable • Scientifically sound • Residues should be : • Active Drug • Cleaning agents • Microbial • Endotoxin • Toxic Excipients • Degradants

  Limits, Endotoxins

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