Standard Operating Procedures processing

Incident investigation requirements Mechanical integrity requirements Standard operating procedures Process safety information Management of change Required employee participation Required hot work permits Contractor requirements... 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

The standard operating procedures demand great attention as they reflect personnel safety issues, safe operating limits and quality considerations. They should be written simply and clearly. The level of detail is determined by the training and experience of the operations staff but should also take into account the hazards inherent in the process. 

If operating procedures need to be developed from scratch, this could account for a considerable portion of the pre-startup work. If current, valid standard operating procedures exist, and the toll is only introducing a new set of batch instructions, the task becomes simpler. However, it is recommended that the new batch instructions are reviewed simultaneously with the existing startup, shutdown, normal and emergency operating procedures for the equipment to help ensure potential process deviations are examined and addressed. 

Other information may also benefit the PHA. Standard operating procedures for processing equipment, safe work practices, maintenance or job safety analyses, emergency response plans could be appropriate review items for some PHAs depending upon the toll. 

Prevention Program —Management System —Process Hazards Analysis —Process Safety Information —Standard Operating Procedures —Training... 

Higher risk activities will require more forma management systems. For example, a process that uses a highly toxic raw material may require an extensive pre-startup leak check of the process as part of standard operating procedures. 

Documenting the Process. The net effect of these steps is a process description, defined in terms of customers and suppliers and their interaction. Next, the team can summarize that description in the form of a process flowchart, to illustrate the roles and responsibilities of each process stakeholder (see Figure 6-8). This chart provides the basis for developing standard operating procedures, or other process documentation, that the company can incorporate into existing practices. 

Precision The repeatability characterizes the degree of short-term control exerted over the analytical method. Reproducibility is similar, but includes all the factors that influence the degree of control under routine and long-term conditions. A well-designed standard operating procedure permits one to repeat the sampling, sample work-up, and measurement process and repeatedly obtain very similar results. As discussed in Sections 1.1.3 and 1.1.4, the... 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

Consultants who were members of a particular segment of the food processing industry may be very instrumental in developing the best processing practices and describing them in a standard operation procedure (SOP). Consultants are often able to develop the necessary information for an SOP quickly. 

Control layer Protection layer that is used to maintain the process within the normal operating limits, such as standard operating procedures, basic process control system, and process alarms. 

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. 

An important aspect of the trial is the meticulous monitoring required. This is a process to interact with the subjects monitoring their well-being, the effects of drug and placebo, adverse events, and so on. Information is recorded on the Case Report Forms. All the processes are recorded in accordance with Standard Operating Procedures, which describe how the trial is to be conducted, and GCP. 

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/or internal procedures, e.g., standard operating procedures). The use of informal risk management processes (using empirical tools and/or internal procedures) can also be acceptable. 

---