Question

GOOD VALIDATION PRACTICE (cGVP)
1

What are the requirements for concurrent validation for injectables? is it neccesary to have the cleaning validation of the process?

2

I have answered it earlier

http://www.fda.gov/CDER/GUIDANCE/5831dft.htm
http://www.fda.gov/CDER/GUIDANCE/5831dft.htm

3

Can anyone suggest me about the Retropective validation for Multivitamins. As vitamins syrup/tablets, inculde the overages, whether we need to include the overages or not?

Thanking You

Kiran

4

Kiran:

With the information you have provided, it would be extremely difficult for anyone to give a clear answer. Would suggest you frame the entire issue.

5

Pincemc04:

Depends on where you are selling your product. If your product is going to the regulated markets, i would suggest that you put the cleaning validation on a priority.

6

[quote=kvkiran]Can anyone suggest me about the Retropective validation for Multivitamins. As vitamins syrup/tablets, inculde the overages, whether we need to include the overages or not?

Thanking You

Kiran[/quote]

Already answered the same question by same person on forum
http://www.askaboutvalidation.com/forum/showthread.php?p=988#post988

I request Please dont post the same Q on different Forums.

7

Thanks for your infomration. To be more clear, the product is bieng manufactured from long time and overages are set right from the beginning based on the stability data. The specification is set from 90.0 to 126.5 % including overages for example vitamin-C. How do we consider the data? Do we need to consider outliers or are there any alternate ways of doing the study? Plz do mention me in detail of calculating the Cpk and controls points with individual data ranges?

regards,

Kiran

8

[quote=rmoorthy]Kiran:

With the information you have provided, it would be extremely difficult for anyone to give a clear answer. Would suggest you frame the entire issue.[/quote]

Dear Mr.Moorthy,

Iam performing the retrospective validation for Multivitamin tablet and syrups.Actual label claim is 25 mg but the overage added is 5% (25.0 mg + 1.25 mg).Finished product specification set as per COA is 90-130 %. When calculating the Cpk, what would be the USL & LSL values? Whether it should be as follows:

1.LSL = 90 ; USL = 130 (Specification as per COA)

2.LSL = 90 ; USL = 120 (Specification set as per theoritical weight)

If either of he case is positive plz explain!

Can we include outliers for selection of bathces?

Regards

Kiran

9

[quote=rmoorthy]Kiran:

With the information you have provided, it would be extremely difficult for anyone to give a clear answer. Would suggest you frame the entire issue.[/quote]

Dear Mr.Moorthy,

Iam performing the retrospective validation for Multivitamin tablet and syrups.Actual label claim is 25 mg but the overage added is 5% (25.0 mg + 1.25 mg).Finished product specification set as per COA is 90-130 %. When calculating the Cpk, what would be the USL & LSL values? Whether it should be as follows:

1.LSL = 90 ; USL = 130 (Specification as per COA)

2.LSL = 90 ; USL = 120 (Specification set as per theoritical weight)

If either of he case is positive plz explain!

Can we include outliers for selection of bathces?

Regards

Kiran