Facility Inspection Report

Periodic, scheduled facility safety inspections are essential in any operational area, especially where hazardous tasks are performed on a regular basis. Compliance with safety inspection requirements should not be difficult to accomplish since similar requirements should already exist in an established occupational safety program. The facility inspection encompasses all facets of daily operations and considers the human-machine interface a primary candidate area for potential mishaps. Frequent facility inspections are an excellent method of maintaining current awareness of facility conditions and how those conditions affect, or might affect, the safe operation of that facility. A system should be in place to ensure implementation of corrective actions and to track repetitive items. Results of inspections should be properly documented and accountability for discrepant items appropriately determined and assigned for the inspection process to be effective. If properly performed, the facility safety inspection is an excellent tool in the overall success of the system safety function. 

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If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

The facility inspection should include a review of the computer systems and software to ensure they have been validated. There may be differences between how network systems are validated in contrast to stand-alone systems. The records, procedures, and SOPs for the different systems should be reviewed as part of the facility inspection. If validation reports have not previously been reviewed by the QA unit, the facility inspection may provide an opportunity to review these reports and data. 

It also comprises reporting and internal market (= mutual acceptance of data) requirements. The directive requires that the OECD Revised Guides for Comphance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. 

During a GLP inspection of a facility by the EPA, the inspectors usually examine SOPs and may check the items outlined below to determine the compliance status of the system. Commonly, inspectors request copies of SOPs to include them in the inspection report in support of their observations. 

At the end of the facilities inspection and data audit, the inspector will present the laboratory with a Receipt for Samples form. This form lists all of the copies of documents, samples, etc., the inspection team collected for use in documenting the findings of the audit in their report. The laboratory will be given a closing session in which the auditors and the Inspector will discuss their findings. Frequently, this conference also provides a time for a question and answer session or an exchange of ideas. 

It is recommended that the regulatory status be reviewed by examining the most recent inspection reports on the facilities from which all data were derived for inclusion in the application. This includes manufacturing, non-clinical laboratories, and clinical sites. 

Another general distinction between FDA and EU inspections relates to the disclosure of certain information obtained during an inspection. In the United States, anyone can submit a written request to FDA, pursuant to the Freedom of Information Act (FOIA), to obtain a copy of an FD-483 issued to a company (i.e., a listing of observations by an FDA investigator of a facility s potential noncompliance), the company s response, the establishment inspection report (i.e., the investigator s diary of the inspection), and any resulting enforcement action, such as the issuance of a warning letter. 

Once an equivalent authority receives an inspection report from another equivalent authority (post- or preapproval reports), the receiving authority will normally endorse the report, except under specific and delineated circumstances (e.g., material inconsistencies or inadequacies in inspection report, quality defects identified in postmarket surveillance, and specific evidence of serious concern in relation to product quality or consumer safety [39]. In these exceptional cases, the importing country s regulatory authority may request clarification from the exporting country, which could result in a request for reinspection. In addition, the importing country might conduct its own inspection of the production facility if attempts at clarification are not successful [40]. 

The Review Document reaffirmed the obligation of the CW-possessors to destroy their CW stockpiles within the CWC-specified timelines, and urged them to exploit scientific and technological developments to enable more effective use of verification resources. It also called on other States Parties to support these efforts and provide assistance where possible. In addition, the RevCon reiterated the obligation of States Parties possessing converted former CW production facilities to report annually for 10 years on the activities at those sites and to open them to inspection. 

In the case of manufacturing facilities situated in non-PlC/PlC-S countries, the NIP sends its GMP inspectors prior to the registration. In a number of cases, the negative inspection report resulted in the refusal of the application or its wise withdrawal by the company. 

Inspections are not just an exercise which Quality Assurance performs for its own sake. Since it is the task of Quality Assurance to ensure the maintenance of GLP compliance, it is obvious that any deviations from the rules of GLP that are observed in these inspections should be corrected. Inspection reports therefore serve the dual function of permitting test facility management to judge the functioning of the Quality Assurance itself, and of permitting test facility management and Study Directors alike to institute the measures deemed necessary for a full and continued adherence to the GLP Principles. 

Test Facility Inspection An on-site examination of the test facility s procedures and practices to assess the degree of compliance with GLP Principles. During inspections, the management structures and operational procedures of the test facility are examined, key technical personnel are interviewed, and the quality and integrity of data generated by the facility are assessed and reported. 

When a Test Facility Inspection or Study Audit has been completed, the Inspector should prepare a written report of the findings. 

Prior to conducting a Test Facility Inspection or Study Audit, Inspectors should familiarize themselves with the facility which is to be visited. Any existing information on the facility should be reviewed. This may include previous inspection reports, the layout of the facility, organization charts, study reports, protocols and curricula vitae (CVs) of personnel. Such documents would provide information on ... 

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