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CCP Validation Report-LS23005

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Prashant Jadhav
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549 views2 pages

CCP Validation Report-LS23005

Uploaded by

Prashant Jadhav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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UNICORN NATURAL PRODUCTS PRIVATE LIMITED

CCP VALIDATION FOR TRAY DRIER

Report Number: TD-VAL-LS-2024 Date: 29th January 2024

Sample Description: Banaba Extract, Batch # LS23005/Lot-1

After completion of Tray drying process


Before loading into Tray dryer
Testing parameters Testing laboratories Dried powder Dried powder
(Cake)
(Bag 1) (Bag 2)
Loss on drying.
In-house lab --- 1.58% 1.64%
(NMR 5% w/w)
Water activity External lab 0.9921 0.4602 0.5509
Total plate count In-house lab <10 cfu/gm <10 cfu/gm <10 cfu/gm
(NMT 5000 cfu/ml/gm) External lab <10 cfu/gm <10 cfu/gm <10 cfu/gm
Yeast and Mold count In-house lab <10 cfu/gm <10 cfu/gm <10 cfu/gm
(NMT 100 cfu/ml/gm) External lab <10 cfu/gm <10 cfu/gm <10 cfu/gm
Coliforms In-house lab Absent/gm Absent/gm Absent/gm
(Should be Absent per ml/gm) External lab <10 cfu/gm <10 cfu/gm <10 cfu/gm
Enterobacteriaceae / Bile-tolerant In-house lab <10 MPN/gm <10 MPN/gm <10 MPN/gm
gram-negative bacteria
(Should be less than 10 MPN/ml/gm) External lab Absent/10 gm Absent/10gm Absent/10gm
Salmonella In-house lab Absent/25 gm Absent/25gm Absent/25gm
(Should be Absent per ml/gm) External lab Absent/10 gm Absent/10gm Absent/10gm
Escherichia coli In-house lab Absent/gm Absent/gm Absent/gm
(Should be Absent per ml/gm)
External lab Absent/gm Absent/gm Absent/gm

Prepared by Approved by
Assistant Manager- Microbiology Assistant Manager-Quality Assurance
Page | 1
UNICORN NATURAL PRODUCTS PRIVATE LIMITED

CCP VALIDATION FOR TRAY DRIER

After completion of Tray drying process


Before loading into Tray dryer
Testing parameters Testing laboratories Dried powder Dried powder
(Cake)
(Bag 1) (Bag 2)
Pseudomonas aeruginosa In-house lab Absent/gm Absent/gm Absent/gm
(Should be Absent per ml/gm) External lab Absent/gm Absent/gm Absent/gm
Staphylococcus aureus In-house lab Absent/gm Absent/gm Absent/gm
(Should be Absent per ml/gm)
External lab Absent/gm Absent/gm Absent/gm
Listeria monocytogenes (ISO 14988) External lab Absent/25gm Absent/25gm Absent/25gm
Bacillus cereus (IS method) External lab <10 cfu/gm <10 cfu/gm <10 cfu/gm
Clostridium botulinum (IS method) External lab Absent/25gm Absent25/gm Absent/25gm
Clostridium perfringens (IS method) External lab Absent/25gm Absent/25gm Absent/25gm
Report Number: TD-VAL-LS-2024 Date: 29th January 2024

Sample Description: Banaba Extract, Batch # LS23005/Lot-1

Conclusion:
a) During the validation study, Sampling of chemical (including water activity) and microbial parameters 4 additional parameters as per USFDA
Appendix-1P at before (Cake) and after Tray drying (Powder extract).
b) Based on in-house and external laboratory results of chemical and microbial parameters, All the results are meeting as per in-house
specification.
c) No deviation / No out-of-specification was observed at CCP validation of Tray dryer.
d) Hence CCP validation of Tray dryer is effective.
e) Next due for CCP validation is January 2024.

Prepared by Approved by
Assistant Manager- Microbiology Assistant Manager-Quality Assurance
Page | 2

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