Quality Control System QCS

There are four general steps to ensure this control and consequently to guarantee the data quality [32] quality control checks (QC), system suitability tests (SSTs), analytical methods validation (AMV), and analytical instrument qualification (AIQ) (see Figure 5). 

Quality assurance and quality control (QA/QC) A system of procedures, checks, and audits to judge and control the quality of measurements and reduce the uncertainty of data. Some quality control procedures include having more than one person review the findings and analyzing a sample at different times or using different laboratories to see if the findings are similar Quantitative risk assessment (QRA) A process that relies on mathematical modeling and estimations usually derived from animal test results and the probability of risk for a chemical substance at the low dose to which the human population is normally exposed Radionuclide A nuclide with radioactive properties... 

Konieczka, P. The role of and place of method validation in the quality assurance and quality control (QA/QC) system. Crit. Rev. Anal. Chem. 37, 173-190 (2007)... 

Quality assurance/quality control (QA/QC). A system of procedures, checks, audits, and corrective actions used to ensure that field work and laboratory analysis during the investigation and cleanup of Superfund sites meet established standards. 

All processes in the production of PSS columns are controlled by an efficient multistep quality control (QC) system (25). This QC system requires complete tests and documentation for all materials used in all production stages. All QC work has to be performed by specially trained and highly skilled polymer chemists. 

Quality Management System, Quality Assurance (QA) and Quality Control (QC)... 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of the manufacturing environment, raw materials, in-process intermediates, and finished products. 

The objective of QualAID ( ) is to provide advice on how much and what type of quality assiarance (QA) and quality control (QC) is needed for various types of environmental analyses. The purpose of this system is to provide consistently good advice to chemists whose primary field of expertise is other than QA/QC. 

The physicochemical and other properties of any newly identified drug must be extensively characterized prior to its entry into clinical trials. As the vast bulk of biopharmaceuticals are proteins, a summary overview of the approach taken to initial characterization of these biomolecules is presented. A prerequisite to such characterization is initial purification of the protein. Purification to homogeneity usually requires a combination of three or more high-resolution chromatographic steps. The purification protocol is designed carefully, as it usually forms the basis of subsequent pilot and process-scale purification systems. The purified product is then subjected to a battery of tests, which aim to characterize it fully. Moreover, once these characteristics have been defined, they form the basis of many of the quality control (QC) identity tests routinely performed on the product during its subsequent commercial manufacture. As these identity tests are discussed in detail in Chapter 3, only an abbreviated overview is presented here, in the form of Figure 2.7. 

In the 1990s the major focus was on system validation, on assuring the quality control (QC) of the hardware and software that operated the manufacturing process, automated the laboratories, and controlled the inventory. As that validation process achieved mainstream acceptance and majority saturation it is appropriate to ask What next Where can we and the regulators most productively next turn our attention to maintain continuous quality improvement ... 

The error of an analytical result is related to the (in)accuracy of an analytical method and consists of a systematic component and a random component [14]. Precision and bias studies form the basis for evaluation of the accuracy of an analytical method [18]. The accuracy of results only relates to the fitness for purpose of an analytical system assessed by method validation. Reliability of results however has to do with more than method validation alone. MU is more than just a singlefigure expression of accuracy. It covers all sources of errors which are relevant for all analyte concentration levels. MU is a key indicator of both fitness for purpose and reliability of results, binding together the ideas of fitness for purpose and quality control (QC) and thus covering the whole QA system [4,37]. 

The analysis of quality control (QC) samples with the construction of quality control charts has been suggested as another way of performing PQ. Control samples with known amounts are interdispersed among actual samples at intervals determined by the total number of samples, the stability of the system, and the precision specified. The advantage of this procedure is that the system performance is measured more or less continuously under conditions that are very close to the actual application. 

An established external quality control (QC) scheme is not currently available. Pooled disease control CSF retained from other analyses is used. Aliquots of the pooled CSF are made and stored at -70°C. This CSF is analysed on five separate occasions and the mean and standard deviation determined. For an analytical/diagnostic run to proceed, analysis of QC material must provide concentration values that are within two standard deviations (plus and minus) of the calculated mean for that particular QC. Construction of Levy-Jennings type control charts provide historical information of overall performance and highlight potential deterioration in the performance of the system. 

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... 

---