1 reply to this topic

[Ricardo@vhf]

I have a few questions on point 5.3.7 & 5.3.8:

 

5.3.7 talks about ".. the site shall ensure that the production process is fully validated to meet the stated claim and the effectiveness of the process is routinely verified."

 

5.3.8 talks about "The cleaning methods shall be validated to ensure they are effective and the effectiveness of the procedure routinely verified."

 

Questions:

1. Is there a distinct difference between the two validations? If YES what? Please use examples to explain your point.
2. What does 5.3.7 validation cover if different from 5.3.8 validation?
3. What tests are performed in the 5.3.7 validation?
4. What does 5.3.8 validation cover?
5. What tests are performed in 5.3.8 validation?
6. The routine verification is done how often for 5.3.7 and for 5.3.8?
7. What tests are performed for the routine verification for 5.3.7 and for 5.3.8?
8. Is the validation similar or different to Process Validation and Cleaning Validation in the Pharmaceutical Industry? If YES, please explain? 

 

[MWidra]

I have a few questions on point 5.3.7 & 5.3.8:
 
5.3.7 talks about ".. the site shall ensure that the production process is fully validated to meet the stated claim and the effectiveness of the process is routinely verified."
 
5.3.8 talks about "The cleaning methods shall be validated to ensure they are effective and the effectiveness of the procedure routinely verified."
 
Questions:

 

• Is there a distinct difference between the two validations? If YES what? Please use examples to explain your point.
• What does 5.3.7 validation cover if different from 5.3.8 validation?
• What tests are performed in the 5.3.7 validation?
• What does 5.3.8 validation cover?
• What tests are performed in 5.3.8 validation?
• The routine verification is done how often for 5.3.7 and for 5.3.8?
• What tests are performed for the routine verification for 5.3.7 and for 5.3.8?
• Is the validation similar or different to Process Validation and Cleaning Validation in the Pharmaceutical Industry? If YES, please explain? 

1. Yes
2. Validation of the production process to show that it is properly designed and can fulfill your claims that no allergens are introduced during production.
3. Testing of raw materials before and after to show that no allergens are introduced.
4. Validation of the cleaning methods used when switching from a food containing allergens to one that does not contain them. This validation will show that the cleaning methods are sufficient to remove the allergens you have been using.
5. Testing of the equipment after cleaning to show that no allergens remain.
6. The frequency of verification is "routinely." Have a document that says how often. I would think that samples of a new product that does not contain allergens at changeover would verify that your production process works as well as testing of the cleaned surfaces to show that no allergens remain.
7. That depends on the allergens. You need to investigate if ELISA tests are available for your allergens.
8. Similar, but probably a little less strict.

That's my take on your questions.

Martha