Analyst certification and training

The actual training of the analysts at the receiving end of the methods is an area that has received considerable attention from regulatory authorities and internal quality assurance auditors. There are several options to certify analysts to perform the required test procedures. One possibility is to qualify individual analysts on each method, thereby creating a matrix of methods and analysts. Such an approach can become cumbersome as it would involve substantial documentation with respect to training records for individual analysts. Compliance liability could also result if an analyst who was not certified produced reportable GMP data. 

---

D. Analytical Testing Methods PROTOCOL EXECUTION ANALYSIS OF RESULTS/STATISTICAL PACKAGES DOCUMENTATION OF RESULTS ANALYST CERTIFICATION AND TRAINING TRANSFEROR TECHNICAL OWNERSHIP... 

Quality assurance includes all the quality controls, the generation of expectations (acceptance limits) from the quality controls, plus a great number of other activities, such as (1) analyst training and certification (2) data review and evaluation (3) preparation of final reports of analysis (4) information given to clients about tests that are needed to fulfill regulatory requirements (5) use of the... 

All training should be documented. Some professional associations have introduced an accredited portfolio for members in which the career of an analyst can be documented and their skills clearly listed. Ideally, performance in any course taken should be assessed. Certificates on a wall for merely showing up for class are not sufficient. 

The scope of the transfer should be provided with respect to what laboratories and analysts are affected by the transfer. In some cases, direct analyst-to-analyst transfer might be necessary due to method complexity or the use of new or unfamiliar equipment. In the case of automated methods, transfer from specific robots or workstations in R D to comparable systems within operations would need to be performed. The subject of analyst training and certification will be discussed later in this chapter. 

---