SOP Standard Operating Procedure. In this challenging face of regulatory environment, some of the leading Pharmaceutical companies have found ways to improve quality and costs significantly. In order to drive this kind of beneficial change, first of all the companies must create a culture where all quality objectives are transparent and well understood, and also undoubtedly these goals can be achieved by following certain sets of procedures called as “Standard Operating Procedures” (SOP).
SOP Standard Operating Procedure?
- SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way of 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 or programmatic or technical actions such as analytical processes, processes for maintaining as well as calibrating and using equipment.
- Sops are 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.
- SOP must contain step by step instructions that employ must refer in daily work to complete various tasks more reliably and consistently.
- SOP’s makes clear about followings things;
- What is the objective of SOP (Purpose)
- What are the applicability and use of SOP (Scope)
- Who will be performing tasks (Responsibility)
- Who will ensure implementation of procedure (Accountability)
- How tasks will be performed (Procedure)
SOP Standard Operating Procedure Benefits
- To provide people with all the safety as well as health and environmental and operational information necessary to perform a job properly.
- To ensure that production operations are performed consistently to maintain quality control of processes and products.
- Processes continue uninterrupted and are completed on a prescribed schedule.
- To assure no failures will occur in manufacturing and other processes that would harm anyone in the surrounding community.
- Approved procedures are followed in compliance with company and Government regulations.
- To serve as a training document for teaching users about the process for which the SOP was written.
- To serve as a checklist for co-workers who observe job performance to reinforce proper performance.
- To serve as a checklist for auditors.
- To serve as an historical record of the how or why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed.
- To serve as an explanation of steps in a process so they can be reviewed in accident investigations.
- It helps to prevent the introduction of errors, variations and misunderstanding.
- It improve the planning's and organization.
- SOPs shall be written in a proper and concise, it must be step by step and easy to read and follow format.
- The information presented should be unambiguous and should not be complicated and the active voice and present verb tense should be used.
- SOP shall be simple and short.
- Information should be conveyed clearly and explicitly to remove any doubt as to what is required.
- Flow chart shall also be used to illustrate and explain in brief about the process.
Ideally, SOP’s should be written by teams that include some or all of the following people:-
- One who will perform the job
- One who will perform maintenance on equipment involved in an SOP
- An Engineers or others who design equipment and processes
- One who is Technical initiator
- Again one Safety personnel
- An Environmental personnel
- An Equipment manufacturers
Team which are writing accomplish several goals besides just producing an SOP:
Following are the ideas to keep in mind while writing Standard Operating Procedures (SOP)
- Write some SOPs for people who work alone.
- Write some SOPs for two or more people who work together as a team.
- Write some SOPs for people who will supervise other people doing a job.
- Write some SOPs for the people who not familiar with rules generally understood by your employees.
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