• CaliberLIMS

How Qualified Is Your Quality Analyst?

It is human to be eager about product quality. To ensure top-notch quality in everything we produce, qualified personnel are involved to inspect the products at every stage. We also make sure to follow certain criteria or checklist to engage such qualified personnel. In Pharma Quality Check (QC), where every step must be well measured and documented, sample analysis needs to be done by a qualified analyst or chemist who understands the Standard Test Procedures (STPs) very well. These STPs are specific to the product and hence, the person dealing in it needs to be trained and qualified. Further, the STPs undergo change often for better optimization, which makes it necessary for the QC team to undergo continuous training and qualifying mechanism.

It’s very important that in Quality Control Laboratory (QC Lab), the analysts working in the Analytical Laboratories must be demonstrably trained and up to date with the techniques of the trade and more importantly the Standard Operating Procedures (SOPs).

Industry practice – Certification of the Analyst:

The process of certification applies to all analysts in the Quality Control Laboratory (QC Lab) to ensure that analysts performing the tests are adequately trained to produce reliable and accurate results within the specified acceptable limits. Every analyst or team member is qualified against released sample results. This procedure is applicable for the new employee (experienced or fresher) as well as the existing analyst who is changed from one section to another section e.g. Raw Material to Finished Product or has undergone a change in responsibility. The main goal is to ensure the capability of the analyst to perform analysis accurately and to demonstrate the analyst’s ability to perform certain tests using specific methods required for investigation in the QC laboratory.

Some of the points that are covered in analyst certification:

• Understanding, performing the STP and reporting the results as stated in STP.
• Testing the competency to use the analytical instruments (like HPLC, GCs, etc), and reporting the results if the analyst’s work involves the usage of analytical instruments.
• Evaluating the analytical results and reporting.

CaliberLIMS Analyst Qualification module does not merely capture the pass or fail comment. It is very elaborate with the entire process of qualification being captured with an audit trail. CaliberLIMS Analyst Qualification functionality is meant to facilitate qualification and re-qualification of analysts in the lab, and to maintain a record to demonstrate compliance to regulations.

CaliberLIMS Analyst Qualification Module is tightly bound with the Sample Manager module (the core module which manages the life cycle of the sample under testing) where only qualified analysts are listed for selection to assign analysis work.

AQ module, as it is called, facilitates to
• Qualify or certify an analyst (it generates qualification certificates)
• Requalify an analyst if
o The analyst fails to clear the test.
o The STP is changed and all analysts need to be qualified again.
o Nomination for senior team members is done.
• Categorize tests based on complexity and then qualifying them for accurate results in analysis.

The CaliberLIMS Analyst Qualification Module covers A.Q. Template, A.Q. Training Confirmation, A.Q. Proposal, A.Q. Response, A.Q. Re-Qualification Request, A.Q. Functional Grouping & A.Q. Nomination. Qualification of the Analyst will be done with the Complex and Non-Complex Techniques. Complex techniques will be evaluated with the execution of the released batch with some additional A.Q. limits. Non-Complex techniques will be evaluated with the discussion and question and answer methodology. If you are in need to evaluate your analyst qualification and follow the certification process, trust CaliberLIMS Analyst Qualification Module to solve your issues without much effort and with a lot of ease.