Quality assurance record keeping

If calibrations are being performed, then there will usually be a need to have the facility certified or accredited by an appropriate national or international organization. This certification entails a large amount of additional effort for quality assurance, record keeping and similar requirements. 

A facility that conducts both GLP-regulated and non-GLP-regulated studies should think carefully about attempting to maintain a dual standard in any one laboratory or with any one group of laboratory workers. In the author s experience, such a dual standard is very difficult to maintain without carryover of non-GLP standards to GLP-regulated work. In such a case it may be far better to maintain a general GLP standard (e.g., data collection, record keeping) for all work in the laboratory, but perhaps allow exceptions for the non-GLP studies in areas such as quality assurance (QA) inspections and analytical requirements for test and control articles and article/carrier mixtures. 

It is essential to develop a quality assurance (QA) programme that covers sample collection, sample handling, and methods for on-site and laboratory analysis, data handling and record keeping. The QA programme should address the variety of different scenarios likely to be encountered. Appropriate calibration and analytical... 

Adverse event reporting Trial medication Premature withdrawal Subject replacement policy Criteria for excluding data Data analysis/statistical methods Quality control/assurance Data handling and record keeping Ethics (e.g. IRB/IEC approval)... 

Module II.Further guidance on record-keeping in quality assurance systems is provided in the WHO publication Quality assurance of pharmaceuticals (2,3). 

The exact definition of good laboratory practice depends on who is defining it and for what purpose. A broad definition encompasses such issues as organization of the laboratory, management, personnel, facilities, equipment, operations, method validation, quality assurance, and record keeping. The goal is to certify that every... 

Internal quality assurance is concerned with maintaining precision within a single laboratory, where the importance of keeping careful records, based on reference materials and using appropriate control charts is well established. External quality assurance involves reference materials obtained from an outside body, and is a method for testing the bias of laboratory results. In practice, internal quality assurance mainly has to do with laboratory precision, whereas external quality assurance mainly has to do with laboratory bias (ISO 5725,1986). 

The guide concentrates on the technical aspects of QA with emphasis on those areas where there is a particular interpretation required for chemical testing, and does not cover general quality assurance topics such as quality systems, reports, and record keeping. 

HACCP is not designed to be a complete quality assurance system it is designed to be the part of the QA system that is focused on food safety (microbiological, chemical and physical). Record-keeping and display are vital to the process. Regular audits are also essential to ensure that the process is operating as required. HACCP works best when TQM is the basis of the company s quality philosophy (MFSC/NFPA, 1992). An overview of how TQM may be applied within the food industry is provided by Fulks (1991). 

The frequency of the control sample analysis depends on the nature of the analysis. Successful analysis of the control samples assures that the system is performing as expected under the SOP. Validation of HPLC equipment assures that valid measurements are obtained. The quality of the analytical data can be maintained by keeping, in a safe place, records of the actual instrument conditions at the time the measurements were made. Backups should also be maintained. 

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