Standard operating procedure quality controls

The distribution of the quality manual and standard operating procedures is controlled. 

The standardization of spectrochemical procedures is difficult owing to the variety of material analyzed and the impossibility of producing a standard identical in composition to the sample. It is therefore necessary to determine the extent of interfering effects and to use a standard which will compensate for these. However, CV of better than 3% can readily be achieved with accuracies of the same order at the 0.1 /ig/ml or 10 g level. Spectrochemical methods of analysis are accurate and rapid when correctly used, but as the equipment becomes more complex, the operating procedure, quality control and the maintenance necessary to ensure reliability also becomes more elaborate. 

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 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). ... 

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. 

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. 

Similarly, ethos, the testimonial dependent upon the expertise and credibility of the witness, is critical. Evidence supplied by an impartial and credentialed observer may estabhsh comphance with control standard operating procedures (SOPs), accuracy of documentary evidence, and suitability of code design. Whereas the accuracy of logos transcends its interpretation, however, ethos proof must be evaluated on the basis of its source. Who said so , How does he or she know , and Why should he or she be trusted become the key questions. It is upon the importance of ethos that the important issues of independent, quality assurance (QA), and confirmatory investigation hes. Most ethos testimony takes the form of reports, observational records, and certifications. 

Components are received and are quarantined in ABC Pharmaceutical Industries stores until all testing and certificate of analysis requirements are reviewed and have met the acceptance criteria set forth in manufacturing site standard operating procedures. When all acceptance criteria have been met, the components are released by Quality Control and are ready to be issued for production using the procedures specified in manufacturing site standard operating procedures. 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

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. 

Specifications How good do the numbers have to be Write specifications Pick methods to meet specifications Consider sampling, precision, accuracy, selectivity, sensitivity, detection limit, robustness, rate of false results Employ blanks, fortification, calibration checks, quality control samples, and control charts to monitor performance Write and follow standard operating procedures... 

Every analytical laboratory, governmental, private, or university, has a standard set of procedures that provide both general and specific information to laboratory members. These fall into certain categories, including the laboratory s standard operating procedures (SOPs), quality assurance/quality control manuals (QA/QC manuals), procedural manuals, analytical method files, and laboratory information management systems... 

Test system sanples which are relatively fragile and differ markedly in stability and quality during storage shall be retained only as long as necessary to insure the validity of the study. There shall be appropriate standard operating procedures for disposal of test system sanples. Sanples of test or control... 

While these are two separate and distinct activities, each must complement the other to ensure a quality program. Day to day quality control in the laboratory is the obligation of the chemist. The chemist develops the methods, calibrates the instruments, and with management approval develops the standard operating procedures for the laboratory. Quality control is running duplicate samples, reagent blanks, fortification samples, linearity checks and confirmatory analyses. 

Standard operating procedures (SOPs) are required for all routine activities that are critical to the successful outcome of the study including quality assurance procedures and inspections. Most of the SOPs for the field activities are written by the field scientists with guidance from the Quality Assurance Section. For the field activities, it is required that at each site there be SOPs for such things as how field plots are established and the plot boundaries marked, the maintenance of sample freezers, how to calibrate and maintain chemical balances and chemical application equipment, and how to obtain test chemicals. If an SOP for a critical item of equipment is not available, the study would be considered to be not in compliance with the principles of the GLP guidelines. The distribution of SOPs is carefully controlled so that when an SOP is changed, all outdated copies can be exchanged for the new version. 

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). 

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