Reg: Microbiological assay method validation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Dear Forum Members,

This is Srinivas, Working as a R & D microbiologist. Does anyone have the idea about microbiological assay method design and validation.

Srinivas Kasam

2

Dear Forum

   I need help for microbiological assay validation.

All guidelines are specific for chemical but none is clearly guiding for microbiological assay validation. Kindly share if you have any guidelines for micro assay validation

regards
sonalika

3

[quote=sonalikaparashar]Dear Forum

   I need help for microbiological assay validation.

All guidelines are specific for chemical but none is clearly guiding for microbiological assay validation. Kindly share if you have any guidelines for micro assay validation

regards
sonalika[/quote]

Dear Sonalika,
same parameters which have defined in ICH Q2R1 must be followed (linearity, precision, accuracy e.t.c) inMicrobiological assay validation. But the in microbiolgical limits and acceptance criteria are broader than chemical one.
Thanks

4

Dear
Thank you for your reply. Do you have any guidelines mentioning Limits or any papaers which says , how to go about

regards
Sonalika

5

Hi,

Please check in this,

  1. USP XXVII, validation of microbial recovery from pharmaceutical articles, 2259-2261
  2. PDA, technical report No.21, Bioburden Recovery Validation, vol 44 no. S3
  3. 21 CFR 820
6

Hi,
Can anyone explain me about microbial media validation, & How to carry out the same , is mentioned any guidelines??
Thanks,
Vishwesh

7

Dear Sir/Mam,

as far i concerned Microassay validation,

we go for accoracy, precision, Mean, Variance, Stdev, RSD, applications of one / two way ANOVA and setting up the 95 % confidence interval.

Do perform in 6 replicates with variation in analyst and to determine the actual spore suspension used for all the 6 replicates.

I hope that these will clear your queries.

Regards,

kvkiran

8

What is the reason of Preparing seed layer and base layer in Microbiological assay,

Please tell anybody.???.

Thanx in advance

9

It is similar. Precision is precision anywhere. How reproducible are cfu from the same stock? How reproducible are the colonies plated. How linear are the dilutions and how stable is the sample or plated result. All I have described here can provide without accuracy. To get that with micro is more difficult since true reference materials are not available. A work around may be the use of McFarland standards to estimate the counts in a stock which is then used to inoculate a sample. If stable the initial counts in the sample can be estimated from the dilution factor and the original stock estimated by McFarland . This would also require you to validate the McFarland method with regard to precision And accuracy.