Development of SOPs

Norms are established through the development of SOPs, technical operating procedures (TOPs), and working... 

Norms are established through the development of SOPs, technical operating procedures (TOPs), and working guides (such as help screens and manuals). These procedures are communicated to users through a combination of memos, manuals, training, and support. 

D. Task-specific hazard analyses must lead to the development of written standard operating procedures (SOPs) that specify the controls necessary to safely perform each task. Detailed hazard analyses conducted for each site task and operation provide the basis for developing SOPs to protect employees from safety and health hazards. Written SOPs provide a mechanism for informing employees of procedures that ensure their safety and for enabling management to enforce hazard control procedures. 

Standard operating procedures (SOPs) are step-by-step job instructions which can help workers perform their jobs safely and efficiently. When the end users are involved in their design, SOPs can provide a basis for arriving at a method of work agreed-to by different shifts. In this sense, SOPs can be used to develop training programs and specify measures of competence. Because of the importance of SOPs in the work situation, a systematic framework is needed to enable the design of reliable procedures which are acceptable by the workforce. 

Processing technology references this is a list of the commercial process references used to describe the commercial process conditions used in the development of the laboratory scale SOPs. 

A HAZOP is performed on all new chemicals following process review, preliminary equipment review, and development of preliminary standard operating procedures (SOP). What-if and checklists are typically used to review a process without process design and chemistry changes. 

The importance of documenting internal processes in the form of SOPs has already been mentioned. Any activity forming part of the development plan is a process. Each SOP should be looked on as a dynamic document and opportunities for improving each process should be sought continually. For example, the time that elapses between the last patient completing a clinical trial and production of the statistical report is an activity very much on the critical path. 

The ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM provides guidelines to those involved in the development of quality system manuals and applicable standard operating procedures (SOPs) to comply with the requirements of international standard ISO 9001 2000 and proceed with the registration/certihcation process. The quality manuals (models) and SOPs provided in the CD-ROM are also a valuable tool for the companies to transform their existing ISO 9001, ISO 9002, and ISO 9003 quality manuals and SOPs to meet the requirements of revised standards. 

Documentation requirements are predicated on the types of batches to be manufactured at the pilot facility. For the development of novel formulations, laboratory notebooks are the primary source of documentation. Room and equipment logbooks should be maintained. Personnel training records and SOPs must also be maintained. Once the facility is used for the larger-scale batches described earlier, what was recommended now becomes required. Manufacturing runs need to be documented accurately, preferably in batch records. Logbooks should maintain an accurate record of the product history in rooms and equipment. At this level of manufacturing, it is also important that personnel training records be kept. These... 

The general process of sample transformation into data is the same at every environmental laboratory. The differences are primarily in the manner various tasks are performed by laboratory personnel. To assure the quality of produced data, every laboratory must develop, implement, and maintain a quality system that is documented in the Laboratory QA Manual. The implementation of specific tasks related to sample management, analysis, and quality system, which may be different at different laboratories, is addressed through a set of laboratory s own SOPs. A full service laboratory has dozens of SOPs, describing every laboratory procedure and task from sample receiving to invoicing. The SOPs are updated as necessary and undergo internal review and approval. 

Method development includes feasibility and optimization to meet the predefined study requirements. The appropriate standard calibrator range and concentrations of VS and QC (see discussion below) should be established for the dosage form and route of administration. The lessons learned during method development are critical for the development of specific parameters for the performance of the assay. For example, the number of validation batches and acceptance criteria should be described in a validation plan, and the standard operating procedure (SOP) should be written before conducting the pre-study validation. The correct approach should be to develop a valid (acceptable) method, rather than simply... 

Scope The instructions given in this SOP provide detail as to the development of a master production record to be utilized in routine plant operations. 

The Quality Assurance organization has no mandated role in the development of computer systems other than defining QA fnnctional reqnirements. Once the system has been validated, accepted, and installed, QA will be responsible for monitoring data collection until its reliability is confirmed in accordance with SOP, compliance of nser SOPs, training, and secnrity policies. Any performance problems shonld be commnnicated to the responsible management persotmel in a timely fashion. QA shonld monitor corrective actions and nnschednled downtime records. 

In addition to system and technical confignration documentation created as part of the development of changes, it is essential that any nser mannals issued to support the use of computer systems in conjnnction with the local SOPs are npdated whenever reqnired. These mannals shonld display indication of review and snbseqnent approval, and should also clearly indicate which revision of the software that they apply to. This is especially important if these nser mannals are developed by external software honses. 

Advisory Committee on Acute Exposure Guideline Levels for Hazardous Substances (referred to as the SOP manual), which documents the procedures, methods, criteria, and other guidelines used by NAC in the development of the AEGL values. The information contained in the SOP document is based on the guidance provided by the NRC in its guidelines report (NRC 1993). The SOP document contains further details and clarification of specific procedures, methods, criteria, and guidelines interpreted from the NRC report. 

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