Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the "standard" approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done and are kept current by review and approved revision on a predetermined schedule (usually annual), or when planned changes are made to the procedure or equipment and reagents used in the procedure. The original of a current version of an SOPs is maintained in a central file, and copies are distributed to the locations where the procedure is performed. The procedure for describing the writing, revising and approving of SOPs and the control of the distribution of SOPs is one of the important quality assurance procedures. The term “change control” has recently been introduced to the vocabulary of pharmaceutical manufacturing and control. Although this is primarily a term for validation procedures, it may also apply to the control of the review and revision of SOPs for routine procedures. Any SOP describing the distribution and control of documents must clearly indicate the mechanisms by which SOPs can be modified or changed: from assessment and rationale for the need for a change to the evaluation of other SOPs that might be changed as a result, to the final approval of changes and the implementation of the changed procedure. SOPs are used as a reference by the persons responsible for the performance and are also used for training new operators in the performance of the procedure. Quality assurance procedures should be in place to ensure that SOPs are enforced and properly used.
SOPs follow a scientific format and are written with the view that they will be used by persons trained in the procedure. They should be specific instructions for each step in sequential order including the preparatory work which must be done before starting the main procedure, as well as instructions for recording and reporting the results. There is little need for excess text on theory and background - what is required is clear concise instructions for carrying out a procedure which has been approved.
Usually, the initial draft of an SOP is written by the person performing the procedure or by someone who knows the procedure well and must be written including the details and the time course of the tasks. Supervisors review the SOPs for completeness and content and QC or QA staff approve for regulatory compliance.
When appropriate, a formal data sheet or data record form is prepared for an SOP. This form is a parallel summary document with checklists, checkboxes, and blanks for all data to be recorded during the performance of the procedure. It also has spaces for signatures of the operator and other technicians who verify and countersign certain critical operations during the procedure. Finally, there is the space for the signature of the department supervisor who reviewed the completed data record form. Such blanks and checklists ensure that the required data are collected, that nothing is overlooked and also provide the evidence that the procedure was performed according to the SOP. The datasheets also provide instructions for recording deviations to the procedure, for calculations or reporting requirements, for comparison of results with predetermined specifications, and the criteria for repeating procedures in cases where unacceptable results were obtained.
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