Reporting requirements facility inspection reports

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. 

Modem industrial facilities usually are equipped with systems that form the foimdation for the second requirement. Historical inspection data, failure analysis reports, analytical chemistry records, databases of operational parameters, and maintenance management systems are usually in place. The main task, therefore, is one of combining and integrating corrosion data into these existing (computerized) systems. In many organizations, much of the technical infrastructure required for achieving corrosion process control is already in place. Only the addition of certain corrosion-specific elements to existing systems may be needed. 

Inspect has been defined by FDA to mean an actual examination and direct observation of the facilities and operations for a given study while the study is in progress and not merely a review of the records of a study. The QAU function is to observe and report on the state of compliance of a study with the requirements of the study protocol, laboratory SOPs, and the GLP regulations. The QAU role is not just to verify the results of a study. 

The final portion of the GLP surveiUance inspection includes examination of records and reports as described under Parts 58.185, 58.190, and 58.195. To accomphsh this, FDA assesses the fachitys ability to store and retrieve study data, reports, specimens, and so on in a manner that maximizes their integrity and utihty. This must include an overview of how the firm maintains materials such as the raw data and the various specimens that are developed in the course of the study. The investigators must become famihar with the facility s archives regarding their location and accessibility. The individuals responsible for the archives must be identified and FDA must learn whether or not the archive is indexed and if the materials and records that have been transferred and stored elsewhere are appropriately identified. Furthermore, the procedures for adding or removing materials from the archives must be examined and individual test systems are selected randomly to determine that all raw data, specimens, and documents have been retained as required. 

The examination of records and reports usually concludes the GLP surveillance inspection of a facility, although there may be extenuating circumstances that will prolong the investigation and require closer review of a given area. 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

Only chemicals that are considered relevant within the scenario of the proficiency test are to be reported to avoid irrelevant chemicals being reported, in real off-site sample analysis, confidential information on the facility under inspection is revealed (e.g. information on an industrial production process that is not relevant to the implementation of the CWC). This requirement is a consequence of Paragraph C.17 of the Confidentiality Annex of the CWC, l1. The reporting of irrelevant chemicals is penalized with immediate failure of the test see Section 6.1. 

These standards originally concerned animal safety studies today, they are applied to all animal studies, for example, toxicology, pharmacology and animal PK. GLP was legalized as an MHLW Ordinance in 21 March 1997, requiring in particular to establish SOPs and the preparation of protocols and study reports. PMDA is conducting GLP compliance reviews and on-site inspections of testing facilities. 

The FDA requires the name and address of the testing facility to appear in the report so that when the report is submitted in support of a research or marketing permit the laboratory can be added to the FDA s inventory of laboratories that are scheduled for GLP inspection. The name and address may also be used by the FDA to establish the site for any directed audit of the report. 

Section 15 of TSCA, entitled Prohibited Acts, enumerates the acts that violate TSCA. It says, somewhat obviously, that a violation of any reporting obligation, any test rule, or any other requirement of 4 or 5 is a violation. Similarly, it is a TSCA violation to fail to maintain required records or allow the EPA to inspect a facility. It adds a very critical dimension to the list of violations by stating that using a substance that was manufactured in violation of TSCA is itself a violation of TSCA. The most significant language is that it shall be unlawful for any person to. .. (2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of the 5 and premanufacture notification (PMN) rules, a ban or restriction under TSCA 6 or 7, or a rule or order under those sections. 

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