De-SOPing the industry – Michael Herschel

Michael Herschel D-SOPing the industry
Herschel’s Heresies
Under guidance from regulatory agencies and through interpretation of guidelines and directives, the pharmaceutical industry has developed sets of standard operating procedures (SOPs) against which auditing takes place. The justification for SOPs is not only to quantify procedures during trial conduct but also to meet the requirements raised in ICH-GCP, which states that such SOPs should be written and adhered to. The ICH-GCP documents do not stipulate the minimum content of such SOPs, however, it could be deducted that all procedures that directly affect either the protection of study subjects or the integrity of study data should be harmonised in this way.

Although concise, the above introduction could help determine when SOPs are needed and they are not, i.e. when simple procedural descriptions would suffice. In the beginning, SOPs where meant to reflect best practice, however, nowadays it is more usual that specialised personnel write SOPs – very often without previous practical exposure to the very procedures they are describing. One could object that, in learning companies, SOP development could in fact be preventing progress because changing SOPs is very difficult and politically incorrect as there is always the suspicion that simplifying SOPs may result in reduced quality. I know of no case where a reform of SOPs resulted in a significant reduction of either individual SOP length or number – by eliminating the SOPs that would be better replaced with procedure descriptions, which are much more amenable to improvements in process quality.

This is especially true for global companies in which SOPs are usually maintained on a worldwide basis and, thus, are even more difficult to change compared to smaller companies. If one takes the example of monitoring visit intervals, one can see the wide interpretation of what ICH-GCP says. In some companies four weeks is described in eight, in others an “adequate interval” is considered sufficient. I assume that this reflects the desire of ICH-GCP for high quality monitoring (and I may assume that all of them achieve this, probably with slight differences in cost and resource consumption).

It is frequently current practice to issue new or revised SOPs at seemingly random intervals, which intensifies training schedules and forces people to spend much time re-learning. Policies to reduce new issuance of SOPs to what is necessary (to accommodate changes in the legal sphere, for example) to twice or, at the most, four times a year would require that a new SOP should not be longer than its predecessor and that any new SOP must be accompanied by the elimination of an old one. This would be a good first step towards thinning out the SOP “jungle”, which can currently only be survived with a knife capable of cutting through the SOP book.

Another solution to the problem would be to reduce the number of clinical compliance SOP writers by fifty percent. I am sure that such a measure would not reduce the quality of the SOPs because quality is usually dependent on good practice in the field, and this is the responsibility of the clinical research heads.

Let me make some final suggestions. First, members of a SOP department should have sufficient practice of the very procedures on which they are writing and, more importantly, they should not stay longer than five years in a SOP department before having to return to “active duty”. Secondly, they should reduce their SOPs to a minimum in order to enable better use of the brains and motivation of intelligent employees who, if managed well, will find the best procedures for both the protection of subjects and the integrity of data.

If one takes an analogy of what we currently live through then one may return to the dispute of 19th century European military logic. On the one hand the British and Prussian armies relied heavily on the decision making ability of their people on the front line – thus reducing incompetence and red tape while, on the other side, the majority of the remaining continental armies were doing just the opposite and leading by what we now refer to as micro-management. The jury is delayed about which is the better tactic; however, we want neither new wars nor inefficient clinical research.

(C) 2008 – Alle Rechte vorbehalten

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