Monday, May 30, 2011

Differences between SOPs and WPs

Working in industry setting (versus academic), we all understand that it is critical for us to be familiar with the Standard Operating Procedures (SOPs) / Working Procedures (WPs) and follow these procedures. This is even more obvious in pharmaceutical and drug development industry. An employee could be fired not because of incompetence, but because of violating these procedures. A couple of days ago, I attended ChineseAssociation for Science and Technology Annual Convention, one session was to discuss about the requirements for starting up a new company. Several local entrepreneurs elaborated the intellectual property (IP), business plan, funding, a loyalty team, and so on. Nobody mentioned these procedures. But I think that it is equally important to have a set of necessary SOPs and WPs in order to start a new company, especially a service-type company in highly regulated drug development field such as contract research organization. Scientists working in the academic setting often find the difficulties when they try to land a position in industry mainly because they lack the ‘industry experience’ – one critical part is that they lack the experience in following up the strict industry SOPs. If you interview a candidate who does not even understand the term ‘SOP’, you know that your candidate will have a long way to adapt to the industry setting. 

While there are definitions for Standard Operating Procedures (SOPs), it is hard to define Working Procedures (WPs), not to mention the differences between SOP and WP.

Standard Operating Procedure is established procedure to be followed in carrying out a given operation or in a given situation. In clinical trial setting, the SOP is defined in ICH E6 as “detailed, written instructions to achieve uniformity of the performance of a specific function. “  SOP is one of the components of a Quality Management System (QMS) implemented in many large organizations - improve quality by providing a standard format, approach, and application of common processes.. 

The issue may be with the wording ‘detailed’ in this definition. The common understanding within the industry is that SOP needs to be written in a little bit high level and the working procedure provides the detailed steps according to SOP. If the strict definition of SOP from ICH E6 is followed, there perhaps should not be any working procedures. All working procedures should be called SOPs. There is really no defined boundary for separate the SOPs and WPs. For SOPs, say what you do... but do what you say. The documentation is always important to the SOP compliance. 

My personal opinion is that SOPs are the procedures we must follow, typically on high level, with GCP compliance while WPs are procedures we should follow, typically in more detail, for internal standardization and efficiency. For example, in biostatistics, a SOP must be in place to require the independent validation for statistical outputs. A WP may be created to detail how independent validation should be implemented.

Here are some observations about SOPs and WPs:

1) Within FDA, the term SOPP (standard operating procedure and policies) is used for SOPs and WPs.

 2) There are two papers containing good discussions about SOP:
 3) There seems to be no formal definition ‘working procedure’. Different companies may call this differently and different people may have different understanding for ‘working procedure’.
There are some discussions on the web: 

Having SOPs and WPs in place is one thing; having everybody trained on SOPs and WPs is another thing. If SOPs and WPs are written in great detail like step-by-step instructions, the procedures may become a burden to be followed. This could in turn cause issues in SOP compliance when there is an audit. 

Last week, we had a group meeting during the lunch time and we ordered some food from Jason’s Deli. It was good to see that the delivery guy brought a Bagset Checklist which listed the items and quantities for each item. Unfortunately, the guy clearly did not follow their procedure and did not check the check list. When he delivered, he realized that he forgot to bring ‘bulk chips’. He had to go back to pick up this missed item. Had he follow the procedure and check his Bagset Checklist, he would have not missed any item. In this case, the consequence of the non-compliance is minor, but in clinical trials, the consequence of the non-compliance could sometimes be very significant.

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