- 1) In the manufacturing process, the residues of the Active Pharmaceutical Ingredient can adhere to the equipment even after cleaning, potentially impacting the quality of subsequent production cycles. Equipment contamination from cleaning agents like detergents or solvents is also a concern. Therefore, it is imperative to ensure that the processing equipment is free of potential contaminants and suitable for pharmaceutical manufacturing.
- 2) Validation of the cleaning method is essential to ensure that it effectively eliminates not only residues of the API but also other potential contaminants such as degradation products and residues from the cleaning processes.