Regulatory Compliance, Contamination Controls
A cleanroom Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality assurance system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used.
SOPs describe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Project Plan and under an organization’s Quality Management Plan.
SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating, and using equipment. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations.
Standard Operating Procedures Advantages:
If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose.
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