Protocols standard operating procedure

Good laboratory practice (GLP) A system of protocols (standard operating procedures) recommended to be followed so as to avoid the production of unreliable and erroneous data. Accurate record keeping and careful forethought in the design of the study are important aspects of GLP. 

Reference to Written Guidance for Repetitive Tasks While each project may be imique, many tasks in projects are typically repetitive, that is, they appear in many projects. Written guidance goes by many other names such as best practices, bulletins, checklists, guidelines, mini-manuals (Galler 2009), protocols, standard operating procedures (SOPs), and templates (for memos, letters. 

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. 

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

The form these end products take should be consistent with your company s style for example, if you have specific protocols for project planning or developing Standard Operating Procedures, these will probably apply to comparable tasks within the PSM initiative. 

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. 

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. 

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). ... 

The methods to be used and a copy of Standard Operating Procedures (SOPs) where accredited, including any sampling and sample preparation protocols, to be supplied to the customer. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

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. 

Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. 

The requirement to indicate all methods for the conduct of the study does not mean that all laboratory SOPs must be reiterated in the protocol it is sufficient if the protocol indicates what will be done and when it will be done. Laboratory SOPs describe how each study activity is to be performed. If exceptions from SOPs will apply for the study, then those exceptions should be described in the protocol. The FDA has indicated that the protocol should list the SOPs used in a particular study, but the author suggests that a simple stipulation in the protocol that the study will be conducted in accordance with current standard operating procedures is sufficient. Listing each SOP in the protocol could cause problems if SOP identifying numbers or titles change during the course of a study. 

The VMP should be a summary document and should therefore be brief, concise, and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, standard operating procedures (SOPs), and validation protocols/reports. The documentation format is illustrated in the VMP. 

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). 

This manual provides instant answers for quality professionals, quality assurance managers, auditors, and protocol writers regarding what should be made part of quality manual standards and ISO 9000 standard operating procedures to enhance productivity. 

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. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

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