Batch to batch contamination

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

We are opening a new department for the production of Mifepristone 5 mg tablets and I would make you some questions:

  1. The department is dedicated therefore, can I validate a cleaning procedure through only visual check or I must carry out anyway a chemical determination?
  2. How can I calculate the Maximum Allowable Residue if I want consider the toxicological data of the Mifepristone?
  3. Must I use the NOAEL limit of the Mifepristone? If yes, where can I found the NOAEL data?

thanks in advance

2

If the equipment is dedicated to one product then I know of others who have validated using visual only and then defended that validation successfully to the agencies. This only works if you are using WFI only. If you are using detergents - you must validate the removal of the detergents. It seems though that the agencies as of late have been a little more focused on microbial contamination…and therefore I would think it might be a little risky to just do visual only for equipment that sees the final product. Because the equipment is dedicated, you wouldn’t have to do MAC calcs for the product - but you would have to do MAC calcs for any detergents you are using. You should also look for bioburden and endotoxin. Some companies have used the water specs as their cleaning specs. This works great if you can clean that well…but sometimes it is over conservative. To choose the spec to use for the product - you could calculate MAC if you wanted, you could look at what value is “reasonably achievable” you could look at what value matches your “visually detectable” limit, you could use the LOQ of the analytical method…you just need to come up with a risk based, scientific rationale for why you choose the tests and specs that you choose

Hope that Helps

3

thanks for you suggestions