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A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. A technical standard includes definition of terms ...
It documents the approved standard procedures for performing operations safely to produce goods and provide services. [2] Compliance with the operations manual will generally be considered as activity approved by the persons legally responsible for the organisation. [3] The operations manual is intended to remind employees of how to do their job.
Organizations typically document procedures in their published policy and procedures guide, or their standard operating procedure (S.O.P.) guide. A procedures manual or procedural manual typically gathers together a number of procedures used within an organisation, [3] or for a specific set of functions. [4]
Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. A group of pharmaceutical professionals have banded together to create the GAMP Forum, which is now a technical sub-committee, known as the GAMP COP (community of practice) of the International Society for Pharmaceutical ...
Standard operating procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities.
A guideline is a statement by which to determine a course of action. It aims to streamline particular processes according to a set routine or sound practice. [ 1 ] They may be issued by and used by any organization (governmental or private) to make the actions of its employees or divisions more predictable, and presumably of higher quality.
Documentation development may involve document drafting, formatting, submitting, reviewing, approving, distributing, reposting and tracking, etc., and are convened by associated standard operating procedure in a regulatory industry. It could also involve creating content from scratch.