Facilities verification

Definition of the test equipment, support equipment, and facilities needed to carry out the verification activities. 

Test reviews to be held before tests commence to ensure that the product, facilities, tools, documentation, and personnel are in a state of operational readiness for verification... 

FieldNotes user verification can be conducted by following the SOP written by Astrix, which can be downloaded from the Astrix Web site. The SOP contains a script that is typed into the computer system. If the printout matches the SOP script, then verification is complete. A record of this must be placed in the facility archive. This verification process takes 1 h or less. For FieldNotes, calculations are not verified at the field site since the manufacturer feels that the software developer and the sponsors have performed adequate validation of these calculations previously. This may, therefore, require a visit to the sponsor or to the manufacturer to confirm that this important step of the validation process has been completed and is adequately documented. By following the Astrix SOP, the user is simply ensuring that the program operates on their system(s). The SOP script must be typed in exactly as written in order to confirm the printout accuracy. QA must ensure that the verification documentation is properly archived. Just as with any other SOP, this SOP must be approved in writing by field site management to comply with GLP. 

A limited amount of plant-specific data for the coil coating industry is available. Data available in the reference documents on the effluent streams for the plants discussed in the following subsections are summarized in Table 7.7. These data are verification data. All three subcategories are represented by the facilities.1... 

The total number of declared sites (5947) which are to be regularly or randomly inspected shows the high burden of expected verification activities. At this stage of implementation, the verification activities have been obviously concentrated on storage and destruction, and in industry on facilities producing scheduled chemicals. The number of inspections totalled 1936 at 784 sites in 67 countries till December 10, 2004. 

Facility will be equipped with a master control panel and alarms which permits functional verification of the exhaust blowers, filters, make-up air supply systems, fire control systems and waste treatment processes. 

Most hydrocarbon facility process areas and high volume storage areas have standardized on a minimum supply or availability of four hours of firewater for the WCCE. The performance of risk analysis may reveal the level of fire water protection may be more or less than this requirement. Once a detailed design is completed on a facility or if a verification of existing water demands is needed, a simple tabular calculation of firewater requirements can be made. This table can be used to document spray density requirements, duration levels, code requirements and other features. Table 23 provides and example of arrangement to document such information. 

Design Qualification (DQ) This provides documented verification that the design of the facilities, equipment, or systems meets the requirements of the user specifications and GMP. 

Facility personnel who perform testing and maintenance on fire protection equipment and systems must be trained, experienced, and knowledgeable in the systems and the protocols for testing and maintenance. Knowledge can include work history, educational experience, craft certification, manufacturer certification, field verification, and job assessment and testing. Facility person-... 

The TRAACS 800+ is controlled by a personal computer and the features provided include complete interactive control via keyboard or mouse calculation of results as necessary taking into account baseline or sensitivity drift, graphical output of calibration curves for all calibration types—either Hnear or non-hnear, input facility for sample identification data allowing storage on disc and real-time results together with chart traces on a computer printer. The programs allow easy access to input or data files and connection to other computers, and gives system performance verification to CLP standards and built-in QC charts. 

During the verification sampling effort, the ash pond overflows of nine facilities were sampled to further quantify those effluent pollutants identified in the screening program. The data are presented in Table 3A and 3B for information of intake and discharge, respectively. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

Concurrent with the beginning of construction of the baseline incineration facility at JACADS in 1987, the Army requested that the National Research Council (NRC) review and evaluate the Chemical Stockpile Disposal Program (CSDP) and provide scientific and technical advice and counsel. The NRC established the standing Committee on Review and Evaluation of the Army Chemical Stockpile Disposal Program (Stockpile Committee), one of whose early reports was a study of operational verification testing at JACADS prior to the start of agent disposal operations. In the intervening years, the Stockpile Committee produced 27 reports on various aspects of the CSDP. ... 

Until recently, CBER was the only center doing postlicensure inspections and remains the only center engaged in preapproval inspections. CBER surveillance of licensed products was described in 1998 as the inspection of manufacturing facilities for compliance with regulations, verification that product lots conform to preapproval standards and product consistency prior to their release into distribution, and evaluation of surveillance reports, such as adverse experience reports and blood fatality reports (Sensabaugh, 1998, p. 1012). 

When new equipment is purchased or there is a change in the manufacturing site, qualification exercises are performed as part of the validation process. Qualification (installation qualification, operation qualification, and performance qualification) for any equipment or facility is an extreme process which involves testing, verification, and documentation to assure that the particular equipment or facility is per the specification and meets the appropriate standards as defined by vendor and required by manufacturing and engineering personnel [14]. 

The incoming materials are inspected to ensure compliance with the materials specification. The nonconforming materials are rejected. The facility is provided to the customers to perform specific verification test at the company premises. 

Verification of the destruction of mustard in HD hydrolysates has not presented the same technical challenges as VX, but it does require the use of NMR analysis, which takes four to six hours to measure both mustard and sulfonium ions (U.S. Army, 1998b). Verification of agent destruction also constitutes a critical path item in the operational cycle of each facility. Currently, analysis of each batch of hydrolysate takes six hours, provided that reliable analytical results are obtained from the first analysis. Thus, reducing the time required to verify agent destruction in process streams would significantly improve the overall processing efficiency and schedule. 

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