Regulatory requirements and our quality expectations continue to evolve and on this basis Chemika will be changing requirements for sample submission, effective from the 26th of February, 2022, with a phase out of the old system for the month of March.
The new system will require customers to use the relevant submission form provided by Chemika, with samples for total organic carbon (TOC) being submitted with a purpose built form differing from the standard sample submission form. The forms can be downloaded below:
The new system will allow for more comprehensive tracking of when tests were requested and performed on the sample, and the storage conditions for the sample during this process. This will include, for example, whether the sample had been completed and moved to storage prior to further analysis being requested.
To allow for this improved sample tracking, we will require our customers to complete an amendment form which can be downloaded below:
The information you provide will allow us to complete a risk assessment to determine how factors such as storage conditions or the number of container openings could impact on the amended testing requirements. Tests which are sensitive to sample degradation or changes in moisture content could be impacted by storage, and our procedure will assess this impact prior to conducting the analysis and possibly prevent the generation of a result which does not reflect the quality of the batch, and could potentially be a false OOS.
By working with our customers we aim to reduce the time to deliver results, and part of this is to avoid unnecessary complications arising from investigation of OOS or OOT results.