Technical operating procedures

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. 

Operating procedures written in language not understood by operators (confusing, technical jargon). 

Are operating procedures reviewed regularly by a technically qualified professional If so, how often ... 

Nuclear Weapon Major Assemblies are packaged for shipment in accordance with the applicable service technical manuals viz, Army-TM s (Technical Manuals) (Ref 35), Navy-SWOP s (Special Weapons Operational Procedures), and Air Force-TO s (Technical Orders), etc. 

The individual scientist is the key to the production of quality data and must have technical competence and a dedication to quality work. Passive following of good laboratory practices and good measurement practices is not enough. Involvement in their development is required if the quality assurance program is to be credible. Standard operations procedures (SOPs) do not minimize the need for technical competence. Analysts exhibit varying degrees of proficiency when... 

In contrast to the quantity of solvent 1 used during the reaction, the quantity of extraction solvent 2 (work up) increases during scale up (Laboratory 100% Operation 103%), especially when it is related to substrate 2 (Laboratory 100% Operation 169%). Compared to the yield obtained from the literature protocol in which an extraction procedure is missing, an efficient extraction seems to be important in order to achieve sufficient product accumulation. However, as the mass index and the environmental factor demonstrate with respect to the possibility for reducing the volume of water used (see above), solvent 2 demand should be able to be reduced as well, since less water use means less solvent is required for extraction. StiU, at least the recycle rate of solvent 2 is as high as 72.8% (from 169% to 46%, Table 5.1), regarding the current data of the technical operation scale. 

Personnel training and performance-as a management systems element-focuses on development of process knowledge and documentation, including clearly defined technical information and operating procedures (CCPS, 1989). 

Both IChemE (Barton and Rogers, 1997 p. 137) and HSE (2000 p. 42) briefly address operator training in systems that involve reactive hazards. None of the guidelines, however, address the transfer and communication of this information to technical personnel. There is little guidance on integrating reactive hazard information into operating procedures, training, and communication practices. 

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. 

Figure 1 is a Flow Diagram of the RCRA permitting process. As can be seen it includes a detailed technical evaluation of the design and proposed operating procedures of the facility to insure that no harm will occur to either persons or the environment from operation of the facility. The major steps in the process are ... 

Technically valid Standard Operating Procedures (SOPs) have to be established and followed. In case of deviations, the impact to the quality is assessed and appropriate corrective and preventive action is taken. All SOP documents have to be controlled and a historical file has to be maintained. 

The study director is not required to observe every data collection event, but should assure that data are collected as specified by the protocol and the standard operating procedures (SOPs) and that data collection includes the accurate recording of unanticipated responses of the test system. The study director should also review data periodically, or assure that such review occurs, to promote the accurate recording of data and to assure that data are technically correct. 

Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over 10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing. Dr. Haider is the author and co-author of more than 20 research publications in international journals dealing with products of pharmaceutical interest, their isolation, and structure development. He is a professional technical writer and author of more than 500 standard operating procedures based on FDA regulations, ISO 9000, and ISO 14000 standard. 

Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. 

Standard Operating Procedure (SOP) SOP-LAB-EQP-005, Bruker EM640S Portable GC/MS with AMDIS Data Analysis Software (Blinded Mode) for Qualitative Analyses of Liquid Samples Prepared by On-site Methods, Version 3, The Technical Secretariat of the Organization for the Prohibition of Chemical Weapons, The Hague, 1999. 

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... 

---