Validating cleaning procedures protein
The Validation of the Cleaning Procedures is establishing documented evidence that the procedure is effective and capable for removing the contaminants associated with previous products, residues of cleaning agents as well as the control of potential microbial contaminants.
The Cleaning Validation is not only ensuring the compliance of the regulatory requirements, but a more important benefit for performing cleaning procedure validation is the identification and the correction of the potential problems which could compromise the safety, efficacy or quality of the subsequent batches of drug product.
I need to write Cleaning Validation Protocol for cleaning validation of equipment and working surface.
The method, which I have to use, is determination of residue protein by Bradford protein assay.
The objective shall be to demonstrate that there is no microbial proliferation in equipments during storage.
Necessary equipment (brushes, etc.) must also be clean and stored in a clean, sanitary manner.
Cleaning/sanitizing procedures must be evaluated for adequacy through evaluation and inspection procedures.
Gupta lane, Kolkata-700 050, India ABSTRACT: The objective of Cleaning Validation is to establish cleaning procedures & residue limits that are practical, achievable, and verifiable and assure safety.
Pharm (Pharmaceutics), MBA (HRM), MPHIL (MANAGEMENT) Senior Chemist, Albert David Limited.5/11, D.