About this document
Cleaning Validation Guidelines for APIs by swanandkul is a document available to read on EtoBox.
The main objective of cleaning in drug manufacturing is to remove residues from a product that was just manufactured, to prevent those residues from contaminating the next product made. Regulatory requirements include validation and procedures for cleaning, sampling plans, analytical methods, limits, and cleaning agents. Acceptance criteria for cleaning must be practical, achievable, verifiable, and scientifically sound. Determining acceptable residue levels is based on pharmacological dosage, toxicity of t
- Author
- swanandkul
- Language
- EN