STANDARD OPERATING PROCEDURE (SOP)

STANDARD OPERATING PROCEDURE

A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOP's aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. The development & use of SOP's is an integral part of a successful quality 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. For this document, SOP will be used. SOP describes both technical and fundamental programmatic operational elements of an organization. Since each institute operates and functions differently depending on varying circumstances, and has its own ways of carrying out certain procedures, the SOP's in different factories will differ. However, the basic content, structure, and concepts of SOPs will obviously the same. The development and use of SOPs minimize variation and promote quality through the consistent implementation of a process or procedure within the organization, even if there are temporary or permanent changes. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility. The organization should have a procedure in place for determining what procedure or process need to be documented. SOP's should be written with sufficient detail so that someone with limited with or knowledge of the procedures, but with a basic understanding, can successfully reproduce the procedure when unsupervised. SOP's should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOP's are actually tested by individuals other then the original writer before the SOP's is finalized. The finalized SOP's should be approved as described in the organization's quality management plan or its own SOP for the preparation of SOP,s. SOPs should be also systematically reviewed on a periodic basis to ensure that the policies and procedure remain current and appropriate, or to determine whether the SOP,s are needed. The organization should maintain a master list of all SOPs.                          

1. QA SOP's
2. QC SOP's
3. PRODUCTION SOP's
4. ENGINEERING SOP's
5. ASEPTIC MANUFACTURING QA SOP's
6. MICROBIOLOGY SOP's 
7. WAREHOUSE SOP's