Dear all,
I am performing cleaning validation in a small pharma company that manufactures a rather wide range of products.
During our first steps into cleaning validation, we were advised to seperate our sampling protocols (e.g. microbial, API, detergent) in order to minimize problems in case of possible failure. Validations written in this manner have already been audited here, without any criticism on this subject.
Since protocols have been seperated this has allowed us to choose (when applicable or deemed necessary) the exact same sampling sites for API and microbrial residue determination, in any given equipment.
My question is - given that the protocols are seperate and sometimes require sampling of the same exact site for different tests - would there be a reason to criticize a validation performed so as that the three validation runs done for API residue were after different batches than those that were sampled for detergent or microbial contamination?
Hello,
I think you have to compile the cleaning validation proedure and criterias for microbial and chemical or detergent within the same protocol for completing the validation run at once.
one validation run consist about whole procedure and acceptance criterias for single comprehensive programme.
I know that this is the case in most process validations, where results obtained during different stages of a process are relevant to each other, but in cleaning validation when all tests are for the end result of the process what is the rationale? Is the reason simply that seperate tests “look suspicious”? These questions are ony relevant, of course, assuming there have been no changes to the cleaning process and it is performed with little variability…
I know that this is the case in most process validations, where results obtained during different stages of a process are relevant to each other, but in cleaning validation when all tests are for the end result of the process what is the rationale? Is the reason simply that seperate tests “look suspicious”? These questions are ony relevant, of course, assuming there have been no changes to the cleaning process and it is performed with little variability…[/quote]
Dear mrhoover,
the separation of the cleaning validation for three main types of contaminants is not “suspicious” at all, in fact it is the common practice. Reasons are the overlapping of sampling points, different worst cases (DEHT may require different products for chemical and for microbiological cleaning validation), cross contamination of sampling points during sampling, etc. Actually, if all were carried out at the same time, if I was an inspector I would get suspicious about the scientific soundness of the validation approach. Really the only requirement is that the cleaning procedure is exactly the same, because after all it is what you are validating…