Standard operating procedures validation

Reference method Regulatory method Standard method Standard operating procedure Validated method... 

If operating procedures need to be developed from scratch, this could account for a considerable portion of the pre-startup work. If current, valid standard operating procedures exist, and the toll is only introducing a new set of batch instructions, the task becomes simpler. However, it is recommended that the new batch instructions are reviewed simultaneously with the existing startup, shutdown, normal and emergency operating procedures for the equipment to help ensure potential process deviations are examined and addressed. 

Precision of a complete analytical procedure, i.e., a standard operation procedure (SOP), should be characterized by the uncertainty of measurement (absolute or relative) as exactly as validation it stipulates. 

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

The requirements or prerequisites of the Basis Documents are fixed. Basis documents have targets they can be updated and are applicable over a longer time interval (e.g. standard operation procedures). Proof Documents contain proofs of operations and the details of the actual stock they are not changeable and are only valid for single incidents (e.g. test reports). 

Technically valid Standard Operating Procedures (SOPs) have to be established and followed. In case of deviations, the impact to the quality is assessed and appropriate corrective and preventive action is taken. All SOP documents have to be controlled and a historical file has to be maintained. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

A quality assurance component must be integral to the study to verify the accuracy of its measurements and to estimate a precision for each one. This component should include co-located sampling, replicate analysis, station audits, data validation, interlaboratory comparisons and a full set of standard operating procedures. The quality of the data set generated should be discussed and should include the results of validation, analysis of outliers and overall estimates of accuracy and precision. 

In summary, when using the indirect" technique for optical trace analysis, all of the points mentioned above have to be considered and have to be validated when setting up a standard operation procedure" (SOP), in order to conform to good laboratory practice (GLP) analysis methods. This means an extra work load compared with validation of the direct optical trace analysis procedure. Sometimes there is no way of getting round this so-called less elegant , more cumbersome and more error prone indirect technique. However, if it is performed correctly and judged critically, it is still a good method and should easily allow optical trace analysis down to 0.1% and lower. 

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