SPDS Set 1 ERP Book

CHON-004

the ability to meet the fitness for purpose.

This method should contains some procedures to verify the potency of the chondroitinase enzyme. Each lot of enzyme needs to be tested for potency - use of a COA is not adequate. The method needs to contain a procedure to verify the purity of the disaccharide standards. These compounds are very unique - and purity is important. Using a COA is not acceptable. Performance Characteristics The method will cover the analytical range that is specified in the SMPR. (1-100%) This method appears to be capable of measure the 1% limit of quantification that is specified in the SMPR. The method accuracy is reported to be very good - but it is slightly outside of the SMPR requirements of 92-105% for finished products.

Method Optimization

Analytical Range:

LOQ:

Accuracy/Recovery

The method meets the SMPR accuracy requirements of 98- 102% in raw materials.

The method precision is reported to be very good. The experiments demonstrated RSDr values for raw materials were within the SMPR requirement of <2%. For finished products - some the RSDr values were outside of the SMPR requirement of <3%

Precision (RSDr)

Reproducibility (RSDR)

NA - there was no reproducibility data submitted.

System Suitability

Safety Review

Is the method safe to use as written? Are there any safety concerns with any component, instrument, reagent or instruction of the method? If yes, please clearly state the concerns. Does the method include all necessary safety precautions

Yes

No

Yes