We have a small problem in our sister concern.
They are manufacturing One API it is totally dedicated for each and every step. Since they have not been performed cleaning validation due to these equipments are dedicated. They are perofrming only periodic cleaning not to batch to batch.
I have query, Is it acceptable? Is there any requirement for cleaning validation as these equipments are dedicated for one product?
If cleaning validation is required then what is the criteria. We don’t have next product then what is the limit we can fix.
Kindly supply your valuable input to over come this problem.
It is always wise to validate your cleaning procedure. This helps because if you are asked any questions you don’t have to give reasons why you don’t perform such validations. Prove your method of cleaning works even though your API is dedicated. When you don’t have next product then you can do smaller batch of same product to figure your calculations. If you clean with detergents or IPA you might be required show that these residues are not present. “Is there any requirement?” I hope someone can answer that question.
We have a small problem in our sister concern.
They are manufacturing One API it is totally dedicated for each and every step. Since they have not been performed cleaning validation due to these equipments are dedicated. They are perofrming only periodic cleaning not to batch to batch.
I have query, Is it acceptable? Is there any requirement for cleaning validation as these equipments are dedicated for one product?
If cleaning validation is required then what is the criteria. We don’t have next product then what is the limit we can fix.
Kindly supply your valuable input to over come this problem.
Thanks in advance.
Pulla Reddy Karnati.[/quote]
The reg states:
PART 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart D–Equipment Sec. 211.63 Equipment design, size, and location.
Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
If you have not done a cleaning study how do you determine what is a good length of time before a cleaning is needed? How do you know the cleaning is sufficient (was all the cleaning agent removed?). Those are just some basic questions any auditor would ask.
Can we perform the visual inspection, Clarity of the solution and pH with out determine the Residue of the product. Sodium hydroxide solution is using for cleaning of the equipments. Is it sufficient or needs to quantify the residue of that product. Kindly guide us to overcome this problem.
For dedicated equipment cross contamination is not an issue. Visual examination after cleaning may be used as the sole cleaning validation criteria. Also consider residues of cleaning agents. In case NaOH, may be measuring of conductivity and pH should be appropriate.
My concerns would be cleaning agent residues and micro. Clean equipment hold time and dirty equipment hold time should also be considered. By use of dedicated parts, there is no risk of cross contamination with another API. It is vital that you have risk assessed your cleaning processes to justify your approach. Then carry out the mitigation activities arising from the assessment (may be validation studies). From my experience it is best to have a risk assessment in place - its better than having no written justification for your approach at all. An auditor may question your method and scientific reasoning - that’s their prerogative - but is more defendable if it is a formal documented decision.