Operating Procedures definition

To distinguish between a review and an audit, some definitions will be provided. A review is a critical examination or evaluation of any operation, procedure, condition, event, or equipment item. Reviews can take many forms and be identified as project reviews, design reviews, safety reviews, pre-start-up reviews, and so on. The following discussion of the review process will deal with project reviews associated with capital projects and focus on the area of process safety. 

One of the best definitions is by Attilio Bisio (1) The successful startup and operation of a commercial size unit whose design and operating procedures are in part based on experimentation and demonstration at a smaller scale of operation. He also points out that Smith (2) argued in 1968 that the starting point for scaleup studies is the ultimate intended commercial unit. The professional should scaledown from the design parameters and constraints of that commercial unit so that the smaller scale experiments were most useful in reducing the uncertainties of the commercial run. Smith wrote that scaleup from small-scale studies is a misleading concept. 

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... 

The term ionization may refer to different processes depending on the context. For radiation effects in the gas phase, it usually implies the removal of the least bound electron to infinity. Such a theoretical definition is not feasible in the condensed phase and it is necessary use a heuristic or operational procedure. Thus, in liquid hydrocarbons, one may use the electron scavenging reaction or a conductivity current to quantify the electrons liberated from molecules. It has only been possible to extrapolate the conductivity current at a low irradiation dose and at a relatively low external field to saturation in the cases of liquefied... 

The contents of the manual are divided into three major sections objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001 2000, and the process of documentation development and application for registration and certification. 

Fourth, following written standard operating procedures. There is no mystique to SOPs, they are the heart of any test facility. They assure that everyone follows the same procedure each time, that there is no oral law that supercedes the written text. How detailed should these be There are text books on the market with standard operating procedures written in - just like you go to the stationary or office supply shop and buy a standard form will or rental agreement. You have to fill in the blanks. My definition of an SOP is a written procedure that can be followed by any well informed qualified individual with the complete expectation that the anticipated result will be obtained. Can an instruction book be an SOP Probably not. Most instruction books are written as if they had been badly translated from a foreign language. They are frequently difficult to understand. The instruction book can certainly be a part of the SOP, but rarely the SOP itself. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

There is no uniform operating procedure for field meters, field portable detectors, and field screening kits because different manufacturers make them in different formats. To use them correctly, we must strictly follow the manufacturer s instructions. When selecting a particular model, we need to evaluate its ruggedness, portability, selectivity, sensitivity, and reliability. To produce usable data, we must have a good understanding of the measurement mechanism, its applicability and limitations, and be concerned with the issues of field instrument calibration and maintenance. In this chapter, we will review some basic general chemistry definitions applicable to field measurements and focus on the common types of field analysis. 

In operationally defined speciation the physical or chemical fractionation procedure applied to the sample defines the fraction isolated for measurement. For example, selective sequential extraction procedures are used to isolate metals associated with the water/acid soluble , exchangeable , reducible , oxidisable and residual fractions in a sediment. The reducible, oxidisable and residual fractions, for example, are often equated with the metals associated, bound or adsorbed in the iron/manganese oxyhydroxide, organic matter/sulfide and silicate phases, respectively. While this is often a convenient concept it must be emphasised that these associations are nominal and can be misleading. It is, therefore, sounder to regard the isolated fractions as defined by the operational procedure. Physical procedures such as the division of a solid sample into particle-size fractions or the isolation of a soil solution by filtration, centrifugation or dialysis are also examples of operational speciation. Indeed even the distinction between soluble and insoluble species in aquatic systems can be considered as operational speciation as it is based on the somewhat arbitrary definition of soluble as the ability to pass a 0.45/Am filter. 

Definition of roles and responsibilities for corrective action plans Standard operating procedures governing corrective actions Auditing frequency and general access to site records Change control... 

Audit Definition (ANSI). To conduct an independent review and examination of system records and activities in order to test the adequacy and effectiveness of data security and data integrity procedures, to ensure compliance with established policy and operational procedures, and to recommend any necessary changes. 

The term standard operating procedure (SOP) is properly restricted to CLP operations (see Section 5.2 and below) where it has a precise definition within the terms of the standard. However, the term is widely used by laboratories not complying with GLP as a synonym for procedures to emphasise the importance of following them as standard practice (see Section 2.2). 

The definition for standard operating procedure from the US Food and Drug Administration web site www.fda.gov... 

Definition of master production protocols (21 CFR 211.186 ), through which the operator is instructed (through individual operating procedures) how the various production steps must be carried out. 

In the pipette method (Figure 7.7), concentration changes occurring within a settling suspension are followed by drawing off definite volumes, at predetermined times and known depths, by means of a pipette. The method was first described in 1922 by Robinson [14] who used a normal laboratory pipette. Various modifications were later suggested which complicated either the operating procedure or the apparatus [15]. Andreasen was the... 

A better characterization of laboratory operational procedures in order to optimize the diagnostic approaches may allow a most accurate and sensitive identification of genetic markers likely associated with diseases. Moreover, it may consent a better definition of personalized therapy with obvious repercussions in patient outcomes with neoplastic diseases. 

The conclusions of the investigation team as summarized in the report were The process of sending VX contaminated liquid and saturated spill pillows to the DFS in excess of the decontamination capability of the furnace system appears to be the major cause of the chemical event. There are no other scenarios consistent with the physical evidence observed in bin 135 that could have resulted in the agent levels that were recorded during this chemical event. A faster response from the lab and a procedure that includes an action level for the exceedance of waste control limits would have reduced the amount of time bin 135 was outside of engineering controls. A detailed review of standard operating procedures for bulk solid waste fed to the DFS should be conducted. In addition, a narrower definition of what constitutes bulk solid waste should be developed. ... 

Given the current desire of management to be able to mine data and see trends across studies and the availability of PK/PD repository systems (which we discuss more fully later), the first and foremost operating procedure requirement in pharmacometrics is the definition of key metadata that describes the process flow. Metadata, from the information science perspective, is simply information that describes data that is, where the data goes, what the data is, and what possible... 

However, what is true for a carcinogenicity study may be wrong for an analytical chemistry study what can be applied to an in vitro genotoxicity study could be completely out of question for a field study. Therefore, it would seem to be important to interpret these definitions flexibly and with well considered regard to the study type and the experimental activities connected with it. Thus, it would seem that in order to arrive at a clear situation, the Standard Operating Procedures for the conduct of the various study types, or at least the study plan, should address these issues and define the dates in a concrete way. 

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