Operating procedures descriptions

A specific detailed description and protocol should be written (standard operating procedure (SOP)). 

Step I Defining the System - Collect the information needed to perform the analysis. Information needs include system descriptions, schematics, P IDs, logic diagrams, and operating procedures. Step 2 Establishing Inputs/Outputs - Every GO model begins with at least one input aiul may have many interfacing inputs. The output of the model is determined by the success criteria. 

Many companies have specific protocols for the development and description of standard operating procedures. Like the management systems they detail, these SOPs vary considerably in terms of their otganization and level of detail. While it s clearly premature to develop a specific format within which PSM systems will be described, you can get useful ideas in advance by reviewing written protocols and existing SOPs. 

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. 

The work of Fusillo and Powers (1987) has attempted to define a formal theory for the synthesis of operating procedures. First, it introduced more expressive descriptions of the plants and their behavior, going beyond the... 

In the first chapter of Volume 2 (hereinafter referred to as 21 1) we presented the general framework of MODEL.LA., a modeling language that can capture the hierarchical and distributed character of processing systems. We will employ all aspects of MODEL.LA. in order to develop a complete and consistent description of plants that will satisfy the modeling needs for the synthesis of operating procedures. 

Fig. 6. Hierarchical description of (a) operational states and (b) operational relationships. (Reprinted from Comp. Chem. Eng., 12, Lakshmanan, R. and Stephanopoulos, G., Synthesis of operating procedures for complete chemical plants. Parts I, II, p. 985, 1003, Copyright 1988, with kind permission from Elsevier Science Ltd., The Boulevard, Langford Lane, Kidlington 0X5 1GB, UK.)...

Members of the update team should review a copy of the initial PrHA and check completion of action items. The team should thoroughly review current PSI and descriptions of all process modifications made since the initial PrHA report was finalized. A thorough review of the PSI is necessary to make sure that the PrHA incorporates any new hazardous materials, process technologies, equipment, and/or operating procedures. Finally, the team should review all findings and resolutions from the initial PrHA to assure that they have been adequately addressed. 

Figure 23-1 shows the hazards identification and risk assessment procedure. The procedure begins with a complete description of the process. This includes detailed PFD and P I diagrams, complete specifications on all equipment, maintenance records, operating procedures, and so forth. A hazard identification procedure is then selected (see Haz-ard Analysis subsection) to identify the hazards and their nature. This is followed by identification of all potential event sequences and potential incidents (scenarios) that can result in loss of control of energy or material. Next is an evaluation of both the consequences and the probability. The consequences are estimated by using source models (to describe the... 

Description of the population to be studied Reference literature and related data Standard operating procedures... 

The SLC document typically consists of technical documents with system descriptions. It also has references to standard operating procedures (SOPs) and administrative and maintenance systems. A completed SLC documentation set is typically required prior to using analyzer systems in the pharmaceutical laboratory or manufacturing site. It is also required prior to use of the data obtained by the system in GMP. 

A specific, detailed description of the bioanalytical method should be written. This can be in the form of a protocol, study plan, report, and/or standard operating procedure (SOP). All experiments used to make claims or draw conclusions about the validity of the method should be presented in a report (method validation report). 

The following principles should be used to establish a valid analytical method A specific detailed description and protocol should be written (standard operating procedure (SOP)). Each step in the method should be investigated to determine the extent to which environmental, matrix, material, or procedural variables, from time of collection of material until the time of analysis and including the time of analysis, may affect the estimation of analy te in the matrix. A method should be validated for its intended use with an acceptable protocol. Wherever possible, tire same matrix should be used for validation purposes. The concentration range over which the analyte will be determined must be defined in the method, on the basis of actual standard samples over the range (standard curve). It is necessary to use a sufficient number of standards to adequately define the relationship between concentration and response. Determination of accuracy and precision should he made by analysis of replicate sets of analyte samples of known concentration from equivalent matrix. 

Most commercially available instruments can measure droplet diameters between 0.4 and 1200 p,m, although a number of tubes with different-sized apertures are required to cover the whole of this range (Lines, 1996). The measured droplet diameter is precise, i.e., better than 1 %. The operating procedure for a particular instrument depends on its design, which varies between manufacturers. The protocol given below is therefore fairly general, and the laboratory manuals of specific instrument manufacturers should be consulted for a more detailed description. 

Description of process/environment Quality-related critical parameters Purpose and objectives of the system Major benefits of the system Special requirements Specific training needs System operating strategy Related GMP compliance/regulations Physical and logical boundaries System GMP risk assessment System validation rationale Life-cycle documentation Assumptions and prerequisites Limitations and exclusions Quality-related critical parameters/data Standard operating procedures System requirement specification Supplier and system history... 

Below, sample preparation methods of various types of samples will be briefly discussed. The description is based on sample matrices and is not intended to be comprehensive. Sample preparation techniques originally developed for a specific sample type may, however, also be successfully used for another sample matrix. As a result of international round-robin exercises in the field of verification analysis, a number of recommended operating procedures (ROPs) has been published and tested (34). Further testing of these procedures has taken place since 1995 during proficiency testing under the auspices of the Technical Secretariat of the OPCW. These procedures were developed for the analysis of samples with unknown analytes, in order to allow the identification of as many different chemicals of CWC interest as possible. This approach implies that these procedures can be further optimized in cases... 

The manual also includes a detailed description of the structure and operating procedures of the programme and contains the criteria against which a certification programme is assessed. 

Please prepare a preliminary design for the proposed plant. This design will be surveyed by the Process Development Division and used as a basis for further decisions on the proposed plant. Make your report as complete as possible, including a detailed description of your recommended process, specifications and cost estimates for the different pieces of equipment, total capital investment, and estimated return on the investment assuming we can sell all our product at the prevailing market price. We shall also be interested in receiving an outline of the type and amount of labor required, the operating procedure, and analytical procedures necessary. 

The description of XPS and SSIMS will concentrate on the underlying physical processes that generate surface chemical data. Information on the design of instruments and specific details of operating procedures and conditions have been provided by a number of excellent books and review articles [13-18],... 

In the context of a GLP study (see Section 5.2) the term Study Plan or Study Protocol refers to a protocol which defines in minute detail how work is to be conducted. The Study Plan will be formally agreed by the laboratory and the client and also vetted by the quality manager (see Section 5.1). In order to avoid having to repeat descriptions of common laboratory operations in every Study Plan the GLP laboratory will maintain a library of standard operating procedures which can be cross referenced, as appropriate, in any Study Plan. 

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