Documentation standards standard operating procedure

Are appropriate directions for reacting to out-of-specification situations documented m standard operating procedures ... 

Documenting of standard operating procedures for sampling, chain of custody, QA/QC, survey, logging, and data verification. 

The laboratory quality control program has several components documentation of standard operating procedures for all analytical methods, periodic determination of method detection levels for the analytes, preparation of standard calibration curves and daily check of calibration standards, analysis of reagent blank, instrument performance check, determination of precision and accuracy of analysis, and preparation of control charts. Determination of precision and accuracy of analysis and method detection limits are described under separate subheadings in the following sections. The other components of the quality control plan are briefly discussed below. 

The OPCW has created the following quality system documents to control the proficiency testing. The documents are Standard Operating Procedure for the Organization of OPCW Proficiency Tests (QDOC/LAB/SOP/PT1), Work Instruction for the Preparation of Test Samples for OPCW Proficiency Tests (QDOC/LAB/WI/PT2), and Work Instruction for the Evaluation of the Results of OPCW Proficiency Tests (QDOC/LAB/WI/PT3). 

In the following, the synthesis of the most often employed stationary phase is discussed spherical silica with an n-octadecyl modification. The synthesis route has been chosen because all synthesis steps are well characterized and documented in standard operation procedure (SOP) protocols. The objective of this work was to develop a manufacturing process for a reversed phase C18-bonded silica column for HPLC according to standardized and validated procedures and to perform certification of the column, the tests and the mobile phases (du Fresne von Hohenesche et al., 2004). Figure 3.13 shows a scheme of the whole manufacturing process, and Table 3.7 summarizes the main steps. 

The following systems or system components can be distinguished local area network (LAN), wide area network (WAN), network operating system (NOS), operating system (OS), application software, database management software, standard application software, hardware, documentation and Standard Operating Procedures (SOPs). Table 13.1 provides examples of systems and components, and the types of changes that may occur with each system or component. 

Existing warehouse equipment should be identified and documented. The labor complement of each area of the warehouse should be determined and the general responsibilities of each person documented. Existing standard operating procedures should be scrutinized and compared against what actually takes place on the shop floor. ITie first step of the master planning process establishes a baseline against which recommendations for improvement can be compared. 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

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. 

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. 

To gather information about the factors which contributed to the above incident, interviews were held with the workers and their management. Relevant documentation such as standard operating procedures and documentation relating to the incident was also collected. A task analysis (see Case Study 3) of the job of the top floor person was carried out in order to examine the operations involved and the factors which could affect job performance. Two techniques were used for the analysis of this incident, namely variation tree analysis and root cause analysis. 

Standard operating procedures (SOPs)— The SOPs are controlled in a way similar to that of specification documents and analytical methods. It must be ensured that the correct versions of the SOPs are accessed and used by the scientists. After use, the hard copies should be destroyed and disposed of properly. An added requirement is that the SOPs should be accessible during working hours without interruption. Hard copies should be available at a manageable location so that the SOPs are available when the electronic system is down. 

Yet under the original requirements of 21 CFR Part 11 both companies would have had to conduct extensive test on the software to write and implement eight to ten standard operating procedures to document the requirements, development, and change history of the code and to record and archive all records. In this case, as in so many, such an investment in time and dollars would have been justihed for the pacemakers but wasted in the case of the tongue depressors. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

In summary, for data to be useful in clinical trial analyses they need to be quantifiable. The data must be either a continuous measure or a categorical value. Free text poses a problem for analysis, and if it is a valuable variable for the statistical analyses it really must be coded. Finally, hardcoding should be used only when absolutely necessary, because it is inherently problematic. Organizations that do allow hardcoding should document in their standard operating procedures (SOPs) that it is an approved business practice and how it is to be used. 

Standard Operating Procedures (SOPs) should be properly authorized, documented and available to the staff carrying out the work. They must also be identified and controlled, so that all staff are aware of the current version and no outdated or altered copies can be used. SOPs should be regularly reviewed to ensure that they are still appropriate for the study programme. A system is required so that superseded versions of the operating instructions are filed and available, in order that studies carried out in the past using the SOPs in existence at the time of the study can be reconstructed if necessary. 

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. 

The requirements or prerequisites of the Basis Documents are fixed. Basis documents have targets they can be updated and are applicable over a longer time interval (e.g. standard operation procedures). Proof Documents contain proofs of operations and the details of the actual stock they are not changeable and are only valid for single incidents (e.g. test reports). 

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. 

They have access to the study plans and Standard Operating Procedures and all updated versions. QA personnel verify in a documented way the compliance of the study plan with the GLP principles... 

All operations that are done regularly in the laboratory, especially the analyses, have to be described in standard operation procedures (SOP). It is useful to describe the standard operations in separate documents and to include only a list of all SOP s in the qnality manual. 

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