Quality control procedures for

With the first part of the project having been completed, two more challenges remained. We first had to decide how we would ensure that the quality of data from each column set remained high. This meant setting up a quality control procedure for each GPC. The second challenge was determining what to do when we ran out of columns from a particular hatch of gel from the manufacturer. 

European Commission (2007) Method validation and quality control procedures for pesticide residues analysis in food and feed. SANCO/2007/3131, available from ec.emopa.eu... 

The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. 

Specific guidance on the initial quality control procedure for a testing laboratory is available as an PDA addendum. The addendum and other practical guidelines are available from Associates of Cape Cod, Inc. 

Conventional quality control procedures for finished product testing encompass three basic steps ... 

In general the quality control procedures for products obtained through biotechnology are very similar to those routinely used with traditional pharmaceutical products in areas such as raw material testing, documentation of process control, and aseptic processing. The fundamental difference is in the type of methods used, so as to determine the product s identity, uniformity, and purity. In the quality control of products obtained through recombinant DNA technology, it is necessary to employ validated tests for the final and intermediary products to ensure the elimination of undesirable impurities. 

The strict specifications and quality control procedures for cartridge manufacture reflect the very important role the cartridge case plays in the discharge process. In addition to housing all the components of a round of ammunition in one package, a cartridge must ... 

Antibody stability in solution cannot be predicted without thorough stability studies technicians are advised to follow proper quality control procedures for stability validation if primary antibodies are to be diluted in the laboratory and utilized for extended periods of time. An advantage to using commercially diluted primary antibodies is the built-in customer protection provided by the regulatory mandates that govern reagent manufacturers. Manufacturers must demonstrate the stability of commercially produced reagents for defined periods to establish a predictable shelf life for their antibody products. 

It is particularly important to put in place quality control procedures for the development of hardware and software for plant automation. Good automated manufacturing practice provides a systematic and structured approach to the development of these systems including change control and validation methods. 

Quintero, C. et al. 2007. Quality control procedures for dose-response curve generation using nanoliter dispense technologies. J. Biomol. Screen. 12, 891-899. 

Performance variations of different lots of the same brand of catalyst still are causes of significant plant problems in the industry. Such experiences justify efforts to develop effective quality control procedures for purchased catalysts. Obtaining a clear understanding of required catalyst properties is a first step. Plant problems and unusual events need to be recorded. The history of catalyst performance in the plant is most valuable to have in developing catalyst specifications. 

Treatment of lard with bleaching earth decomposes the peroxides and increases the content of conjugated trienes, which absorb at 268 nm. This characteristic has been the basis of a quality control procedure for determining whether lard has been bleached (66). 

In spite of these efforts, silica based modified columns are still widely used. Many column-manufacturers have introduced quality control procedures for the synthesis and characterization of silica based columns. Therefore, lot to lot variations from the same manufacturers have been considerably reduced. However, identical phases from different manufacturers can yield different separation behaviors of the same analyte under identical instrumental and mobile phase conditions. (Of 13 phenyl columns investigated for an oncolytics, we found only three columns providing similar separation profile for a 13-component impurity mixture.)... 

Quality control testing of MDI batches is applied to the individual inhaler components prior to manufacture, as in-process controls during the manufacturing, and to the finished product (Table 1). A number of publications describe quality control procedures for... 

Labelling of and quality control procedures for diagnostic molecules... 

Flanges Fraudulent, inadequate flanges from other countries escaped detection and were used on domestically produced equipment and piping systems Excessive search and removal from installed equipment and piping systems where catastrophic failure might have resulted Ensure all suppliers pass audit and have adequate quality control procedures for their supply chains... 

Laboratoiy quality control procedures for sediment bioassays are listed in Ecology (2003). Here we will give a brief overview of how control procedures ensure the quality of ecotoxicological tests. 

Theobald AE (1994) Quality control of radiopharmaceuticals. In Sampson CB (ed) Textbook of radiopharmacy theory and practice, 2nd enlarged edn. Gordon and Breach, Philadelphia Westera G, Gadze A, Horst W (1985) A convenient method for the preparation of 99m Tc(V)dimer-captosuccinic acid ( " Tc(V)-DMSA). Int J Appl Radial Isot 36 349-355 Zimmer AM, Pavel DG (1977) Rapid miniaturized chromatographic quality-control procedures for Tc-99m radiopharmaceuticals. J Nucl Med 18 1230-1233... 

Zimmer AM, Pavel DG (1977) Rapid miniaturized chromatographic quality control procedures for Tc-99m radiopharmaceuticals. J Nucl Med 18 1230... 

There should be a master formula setting out in writing the starting materials and packaging materials (quality and quantity), as well as detailed production and quality control procedures for each active pharmaceutical ingredient. Wherever posable, the master formula should be prepared for standard batch sizes. 

Method Validation and Quality Control Procedures for Pesticide Residues Analysis in Food and Feed, SANCO/10684/2009, Directorate General for Health and Consumers (SANCO), European Commission, Brussels, 2009 (available at http //ec.europa.eu/food/plant/ protection/resources/qualcontrol en.pdf accessed 10/23/10). 

Method Validation and Quality Control Procedures for Pesticide Residue Analysis in Food and Feed (Document SANCO/10684/2009)... 

Standard ISO/IEC 17025 2005 requires a laboratory to have quality control procedures for monitoring the validity of tests and calibrations undertaken. This means that laboratories must perform internal performance-based quality control checks in accordance with Section 5.9 of ISO/IEC 17025 2005 as it applies to every test, technology, and/or parameter within their scope(s) of accreditation in order to demonstrate compliance with accreditation requirements. Reference or fortified material containing known amounts of analyte, at or near the permitted limit or the decision limit (a non-compliant control sample) as well as compliant control materials and reagent blanks should preferably be carried through the entire procedure simultaneously with each batch of test samples analyzed. Ideally, the control samples should also be very similar to test samples and stable over time. The laboratory should maintain a sufficient amount of control material to last for a significant time period (preferably a number of years) and at suitable analyte concentrations. 

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