Audit protocol

The appropriate response to this observation would be for the firm to revisit its supplier qualification policy and procedures to ensure that they meet current regulatory requirements as well as internal quality standards. Second, the firm will present the agency with a package of new and improved procedures and an umbrella policy related to a state-of-the-art vendor qualification program. These procedures will ensure that all critical suppliers are audited and monitored appropriately in accordance with predetermined criteria and audit protocols. Audit protocols will be designed to meet the unique aspects of every supplier. 

Protocol audits are best scheduled when the protocol is still in draft stage, immediately prior to finalization. The purpose of protocol audits is to assess if the protocol complies ICH GCP (1995), ICHE3 (1995), ICH E9 (1998), the Declaration of Helsinki (2006), national regulations (e.g. FDA CFR requirements... 

Protocol Audit An audit of the protocol for this swdy was conducted and reported to the Study Director and Company Mana emeut as indicated above. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

The level of team members effectiveness depends on skills, experience, and the guidance they follow. A formal audit protocol provides the user with step-by-step instructions on how to conduct the audit, and thus can be used by less experienced auditors. Use of less formal assessment guides such as topical outlines requires more experienced auditors. Either way, the skill level of an audit team must be sufficient to enable members to ... 

Examples of an audit protocol and a topical outline are provided in Figures 4-3 and 4-4. Whichever audit tool is chosen, it should be used consistently for all audits. 

FIGURE 4-3. Example Page from an Audit Protocol Format (page 1 of 17)... 

Regardless of which assessment method you choose, assessors and auditors should take detailed notes using a common format to help capture maximum information in a consistent manner. Forms for questionnaires, topical outlines, and audit protocols (as shown in the exhibits) can perform double duty by providing interviewers with a format for notes as well as reporting. 

If your company has an internal EHS audit group or function, consider enlisting its support, either to help you devise a monitoring protocol, and/or to assist with data collection and analysis. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

Audit protocols are tailored to their subject and to the answer desired of the audit. CCPS (1993a) provides more details on audit planning, audit protocols and teams, and other audit issues. 

An effective audit requires the development of a plan or protocol for the audit, establishing ... 

This table may also be incorporated into the PSM program assess-ment/audit protocol and used during periodic PSM program evaluations.9)... 

Have audit protocols been established that include examination of effective implementation of -Investigation follow-up measures -Recommendations ... 

---