Audits and inspections

Pretreatment Compliance Inspection and Audit Manual for Approval Authorities, July 1986 833/B-86-100 NSCEP 833/B-86-100 WRC 833/B-86-100 ERIC W277 NTIS PB90-183625. 

Nonconformity Corrective Action Once design and operational requirements have been set, and inspection and audit put into place, a system to correct deficiencies should be developed. 

Engine failures over a five year span for 138 emergency generators are listed. Discussion of each type of failure is presented. Data listed includes percentage of failure over the population and time period. All failures were presumably insured by Hartford Steam Boiler and subject to functional inspections and audits. 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

The secretary not only can but must inspect and audit chemical facilities and determine regulatory compliance. If the secretary finds a facility not in compliance, the secretary must write to the facility explaining the deficiencies found, provide an opportunity for the facility to consult with the secretary, and issue an order to comply by a date determined by the secretary. If the facility continues to be out of compliance, the secretary may fine and, eventually, order the facility to close. 

Most clinical trials have problems, sometimes detected by inspection and audit. These can usually be resolved and, if so, the regulatory submission must include a full explanation of how they were dealt with. Therefore, an audit trail with all the data should be available, accompanied by a statement by QA confirming that the procedures have been audited. 

Quality assurance unit records are exempt from routine FDA inspection and copying authority on the theory that such records are more likely to be complete and candid if they are exempt from review by the FDA. This exemption extends only to records of QA inspection and audit findings and records of corrective actions recommended and taken. All other QA records are subject to inspection and cop5dng by FDA. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

Does the QAU have SOPs describing inspection and auditing procedures ... 

During and after the coding process, code reviews, inspections, and audits on application software and/or configurable products must be performed. Refer to Chapter 9. The objectives of code reviews, inspections, and audits are ... 

Code reviews, inspections, and audits may make use of high-level system data flow diagrams (e.g., transaction flow diagrams) in order to determine the scope and depth of the reviews, inspections, and audits. 

For studies that have delegated responsibilities to a PI, the study director will rely on that individual to ensure that relevant phase)s) of the study are conducted in accordance with the study plan, relevant SOP, and principles of GLP. The PI should contact the study director when event(s) occur that may affect the objectives defined in the study plan. All communications should be documented. Communication between the study director and the QA is required at different stages of the study. For instance (1) to review study plans (2) to review new and revised SOPs (3) attendance of QA personnel at study initiation meetings and in resolving potential problems related to GLP (4) by responding to inspection and audit reports promptly (5) by indicating corrective action and (6) by necessary liaison with QA staff, and scientific and technical personnel. In certain unforeseen conditions, change of study director becomes essential. Under such conditions, replacement of the study director should take immediate effect. 

As a minimum, the personnel responsible for inspecting manufacturing sites should have relevant qualifications and experience in pharmaceutical manufacturing, quality assurance, GMP, performing inspections and audits, chemistry and quality control. Ideally they should have an inspection background from working with a regulatory authority. 

While it may thus be possible that in certain areas, the different quality systems may be similar to one another, it has nevertheless to be recognised that neither the adherence to an ISO or accreditation standard may replace GLP compliance (for this aspect see the respective OECD Position Paper), nor can a GLP compliant test facility claim the same technical competence as a laboratory operating under an accreditation scheme. However, the existing redundancies in the different sets of rules can make it possible to implement two such quality systems in one laboratory utilising the common points of the two systems to facilitate the tasks of personnel and quality management. The same can be true for the official compliance monitoring inspections and audits, where audit or inspection results of aspects that are fully covered by one system may be accepted by the other without further investigation. 

The foIbwiRg inspections and audits have carried out in relation to this study... 

Process based inspections At or about the time this study was in progress inspections and audits of routine and repetitive procedures employed on this type of study were carried out These were conducted and reported to appropriate Company Management as indicated above. 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

Figure i8 Subdivision of Quality Assurance activities in inspections and audits, without detailing the inspected activities within, and phases of, the conduct of the study. 

Number 12 Advisory Document of the Working Group on GLP, Requesting and Conducting Inspections and Audits in Another Country, Paris 2000... 

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