An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps.
Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP.
The necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP are complex and will be described. These include recordkeeping, safety, training, and other areas.
A poorly written and followed SOP is one of the most common non-compliances that an auditor finds. If you are a laboratory worker, a supervisor, or manager of a laboratory seeking or under GLP or ISO 17025, you should know how to create and maintain a good SOP. Will your SOPs pass an audit or will they become a non-compliance corrective action?
Lecture 1: What is the intention and role of SOPs. What tasks require SOPs? The network of SOPs within the Lab.
Lecture 2: What are the compliance requirements for an SOP? Roles and responsibilities. Can a Standard method be used as an SOP?
Lecture 3: Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt.
Lecture 4: Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt (continued)
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John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.