QA audits

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Some QA auditors prefer to audit printouts of the electronic data rather than the electronic data themselves. This may be partially due to a lack of familiarity with electronic auditing or with the computer system and partially to unavailability of the software to QA. There are several arguments in favor of QA auditing the electronic data rather than the paper data. For one, there may be perceived compliance issues related to the printouts that do not exist in the electronic data (such as no initials and date on the hard copy). Also, QA may not be given printouts of all the pertinent data. 

Times given are for a QA audited report, from completion of the in vivo phase of the study, but excluding any recovery period. It is possible to reduce these times by one-third if given adequate priority. 

The justification for, and execution of, the QA audit are also described, including preparation, key items of interest, a typical checklist of the audit itself, corrective and preventive actions following the audit, and suggested measures for assuring successful operation of the unit. 

This information would be determined by measuring the heat and airflow at various points of the chamber and then calculating the variability of these conditions in it. Since this kind of information on heat distribution provides assurance that the process equipment is properly designed for the required process, it will be the focus of future QA audits. Furthermore, this knowledge is also essential when a very specific drying temperature is needed for thermally labile materials. The qualification thus not only becomes an integral part of the validation program, but also demonstrates how the information may be used. 

On February 10 and 11 (1987, we) met in Geneva, New York and informally audited the Good Laboratory Practices (GLP s) and performed a Quality Assurance (QA) audit of. .. projects chosen at random. It was intended for the laboratory personnel to understand that the audit process would be helpful to their organization and also helpful to the. .. program. The entire staff of the Geneva labs participated in the process in a very cooperative and hospitable manner. 

Defines the frequency and requirements for conducting internal QA audits... 

Internal QA audits must be conducted and documented at a defined frequency to ensure overall compliance, control, and effectiveness of the quality elements. Such audits should be conducted by members of the QAU or third-party compliance specialists and the results reported directly to the senior management of the corporation. The senior management should prepare an action plan to address any deficiencies and follow up to confirm adequate implementation. 

Equipment maintenance and calibration records GLP protocols and amendments QA audit records Standard Operating Procedures Final Study Reports and QA Statements Training records Job descriptions... 

GLP protocols and amendments Exact transcripts of raw data and changes to raw data QA audit records... 

The principle of GEP for the BMS system controlling offices, restrooms, and corridors was adopted. The project milestones were then planned and auctioned in accordance with the combined (cGMP/GEP) plan. The suppher was audited and commissioned with the understanding that it must participate in the risk assessments. It was agreed that savings in project costs would be shared however, the company s QA audit group would assess the whole project and fines could be applied if breaches in quality were detected. 

QA audits — to be performed by specified (independent) personnel as per the agreed schedule. These audits will evaluate the use and performance of the system in its operational and maintenance environment and will also address system users their competency assessment, training, accreditation, proficiency, and supervision. 

An example can be taken from the accreditation systems, in which, in addition to QA audits, departments become involved in self-inspection. Each department can identify a QA representative whose daily responsibility is to review compliance issues, to look at the overall quality policy of the company, and to ensure that between QA audits, self-inspection is performed and that a departmental review is made of these findings with action points and a time plan identified. 

Further, the QA audit function is directly related to safety. QA audits with an encompassing scope include facility and process safety as one of the elements reviewed. 

---