Walker Downey & Associates, Inc.
SOP writing and Training
A standard operating procedure is a set of written instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Every good quality system is based on its standard operating procedures (SOPs). In preclinical research specifically, SOPs are typically defined as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs are necessary for any organization—whether it concerns a pharmaceutical company, a sponsor, a contract research organization, an investigator site, an Ethics Committee or any other party involved in preclinical or clinical research—to achieve maximum safety and efficiency of the performed research operations.
It is therefore a must that all people and sites involved in preclinical studies (both at the sponsor and at the investigative sites) have appropriate SOPs in place in order to conduct preclinical research and to assure compliance with the current regulations (e.g. 21CFR Part 58.81 – Good Laboratory Practices – Standard Operating Procedures). The presence of these quality documents is essential when inspections take place since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GLP or GMP non-compliance is high at organizations with a poor availability of research or operational specific SOPs. Additionally, the people for whom they were written should be aware of them and their need.
Walker Downey & Associates recognizes the importance for your staff to train on SOPs so that they are actually aware of why and how SOPs can play an important role in fulfilling the FDA and other regulatory requirements. We can provide that training or develop your internal program to facilitate that. Where SOPs may be lacking we can help you to write them, or we can review your existing documents. Please contact us to discuss how we can increase your compliance through SOPs.