Auditing statements

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

Trade secrets may be used in developing the information for the process hazard analysis emergency planning and responses, and compliance audits. Materials that are developed involving trade secrets may be treated as proprietary and may require signed statements for tl protection. 

Within your procedures you need to provide a means of identifying which items have been subject to inspection at the subcontractor s premises and the receipt inspection action to be taken depending on the level of that inspection. In one case, the product may have been accepted by your representative on the subcontractor s premises. In another case, a product from the same batch may have been accepted by your representative but not the one that has been delivered. Alternatively your representative may have only performed a quality audit to gain a level of confidence. You need to specify the inspection to be carried out in all such cases. The standard emphasizes that consideration should also be given to the recorded evidence provided. Even if someone has performed inspection at the subcontractor s premises, if there is no evidence of conformance the inspections are of little value. The fact that an inspection was carried out is insufficient. There has to be a statement of what was checked and what results were obtained and a decision as to whether conformance has been achieved. Without such evidence you may need to repeat some of the inspections carried out on the subcontractor s premises. 

The paragraph that discusses the Inspection of a Testing Facility is of significant importance. It is found in both the EPA and FDA GLPs and, in essence, allows government representatives to enter the facilities and inspect and copy all records within the scope of the work at reasonable times and in a reasonable manner. A key statement here is that the EPA (or FDA) will not consider a study in support of an application for a permit if the testing facility refuses to permit inspection. Thus a facility must permit inspection. This inspection, or audit as it is often called, is therefore taken very seriously. 

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. 

The Code of Practice Appeal Board may also require a company ruled in breach to take steps to recover items distributed in connection with the promotion of a medicine. A variety of additional sanctions are available to the ABPl Board of Management following receipt of a report from the Appeal Board. The ABPI Board of Management can reprimand a company and publish details of that reprimand, require an audit to be carried out by the Code of Practice Authority of the company s procedures in relation to the Code and, following that audit, decide whether to impose a requirement on the company to improve its procedures in relation to the code. The ABPI Board of Management can also require a company to publish a corrective statement and, in extreme... 

The list of inspection dates in the QAU statement may not be sufficient to reveal the extent of the QAU audit and inspectional activity for any given study (e.g., when several inspections of a study occur on the same date). For this reason, some laboratories also list the study phases that were inspected even though this is not required by the regulations. 

Financial ratio analysis is only as valid as the financial information on which it is based. If the information provided in the financial statements hasn t been independendy verified (audited), the results of a financial ratio analysis are not likely to give the reader an accurate assessment of the financial performance of that organization. While financial ratio analysis can provide valuable insight to the performance of any organization, it is important that the users of financial ratios are also mindful of their limitations ... 

Upon successful completion of the prevalidation audit, the analytical chemist simply performs the experiments listed in the validation protocol using the analytical method as written. Based on the results of the validation, it may be necessary to revise the method to include details such as solution stability, relative retention times, relative response factors, or cautionary statements resulting from the robustness experiments. 

Reports should highlight strengths as well as weakness within a process, system, or organization. Concise and objective statements should be made relative to the observations. Observations must be based on facts supported by evidence and related to an appropriate predetermined reference standard (or standards). Audit reports need to be very specific and concise with regard to observations and corrective measures. These reports are a tool for executive management to make critical decisions about resource allocation and organizational changes. 

It is important, whenever individual study-based inspections do not take place, that the QA statement must clearly describe the same. For instance, whether the inspection is related to process-based and when performed. The QA statement must also indicate that the final report was audited. 

The NDA filing also triggers a division request for FDA field offices to conduct a preapproval inspection of the manufacturing facilities of the dmg company (sponsor). During this check, FDA inspectors exam a sponsor s production facilities to audit sponsor statements and commitments made in the NDA against actual manufacturing practices employed by the sponsor. 

Accountability. Accountability begins with a clear, explicit, and reasonably specific statement of a company s expectations, objectives, and goals. Example Process safety audits must be conducted based on the relative risk involved. ... 

For each clinical study, there should be statements that the study was conducted in compliance with the informed consent regulations and either the IRB regulations or the Declaration of Helsinki. If any obligations for the conduct of the study were transferred to a CRO, the name and address of the CRO and the obligations transferred should be listed in the NDA. The clinical sites audited or monitored by the sponsor should be identified, either as part of the report for the study or as a separate list. 

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... 

In view of 21 CFR Part 11, audit trails have become a standard part of many database designs. When specifying any database that will include GxP data, it is important to recognize that specifications for Part 11 compliance must go beyond a statement that the application must be Part 11 compliant. Not all designers or suppliers of commercially available solutions will have intimate... 

Vanderpump M, Ahlquist JA, Franklyn JA, Clayton RN. Consensus statement for good practice and audit measures in the management of hypothyroidism and hyperthyroidism. Br Med J 1996 313 539-44. 

After preliminary planning, permit applications must be completed. Many jurisdictions require a detailed environmental audit, which is then described in a report, often called an environmental impact statement, or EIS. Depending on local regulations, the EIS may be issued for public review and comment. Topics covered in an EIS usually include the following fifteen areas ... 

An internal oversight framework has existed within WHO since the early days of the Organization. It is necessary periodically to ensure that all staff understand this function. The WHO smnmary statement on WHO s Office of Internal Audit and Oversight (lAO) which describes its purpose, authority and scope of work, should be read by each member of staff. This document summarizes the expectations for lAO and it furnishes direction for internal audit at WHO. 

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