Inspections activities

Establishing new methodologies to challenge the benefit of some previously undertaken inspection activities... 

You should be familiar with various occupancies and locations in your community where hazardous materials are used, stored, transported, or produced. To accomplish this familiarization, you must complete pre-emergency planning and inspection activities. 

Consequently, measurement of the impact of licensing and inspection on the final outcomes (quality of product and quality of use) is complicated by other factors. The question then becomes how can we measure the effectiveness of licensing and inspection Two approaches are possible a) checking whether the necessary structures for licensing and inspection activities exist or b) using indicators that provide information about the intermediate outcomes of licensing and inspection. 

Enhance the consistency and coordination of the FDA s drug quahty regulatory programs, in part, by further integrating enhanced quahty systems approaches into the FDA s business processes and regulatory policies concerning review and inspection activities... 

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. 

If the accuracy of the design space model cannot be established a priori with statistical significance within portions of the parameter hyperspace, operation in such regimes should initiate supplementary quality assurance (inspection) activities until the design space model can be updated and revalidated. 

Another requirement of the same amendments was the requirement that FDA must inspect every drug manufacturing establishment at least once every 2 years [6]. At first, FDA did this with great diligence, but after the worst CGMP manufacturing situations had been dealt with and violations of the law became less obvious, FDA eased up its pharmaceutical plant inspection activities and turned its resources to more important problems. 

Computer systems validation, as established in 21 CFR Part 211.68, Automatic, Mechanical, and Electronic Equipment, is one of the most important requirements in FDA-regulated operations and an element of the system life cycle (SLC). In addition to the testing of the computer technology, other verifications and inspection activities include code walkthroughs, dynamic analysis and trace analysis. These activities may require 40% of overall project efforts. 

The best way of effectively determining a maintenance schedule is by keeping a detailed log on the history of each valve. Inspection frequency should be based on criteria which is explained hereafter. We will demonstrate how to build a schedule of inspection activities based on historical data for each individually installed valve This procedure starts with installation An SRV is tagged and is given a passport containing all of its data, process data and revision dates with comments and the spare parts used and when. Actually, the basis of this passport already exists when it leaves the manufacturer (on the tag plate) and the basic records of the valve are also kept with the manufacturer for later reference. 

Quality of conformance (how well the product conforms to the specifications required) is influenced by a number of factors, including the choice of manufacturing processes, the training and supervision of the workforce, the types of process controls, tests, and inspection activities that are employed, the extent to which these procedures are followed, and the motivation of the workforce to achieve quality. 

The foundation of the CWC s inspection activities was based around the declaration by member states of their chemical weapons capabilities and activities. Nations with chemical warfare programmes were required to declare their production, storage and destruction facilities, which would then receive top monitoring priority. Nevertheless, the CWC did allow states to maintain research programmes to ensure the integrity of defensive equipment such as gas masks and gas detectors, but these activities were also to be closely monitored since they involved work with the chemical agents listed on Schedule l.9 Otherwise, all other warfare agents, mustard gas, Lewisite, soman, sarin, tabun, VX and the capability to produce them were to be eliminated under the watchful eyes of international inspectors (Table 8.1).10 The convention thus defined chemical weapons as any toxic chemical, or its precursors, intended for purposes other than those not prohibited under this convention for... 

With the passing of the FDAMA, the agency s inspection latitude was increased and its inspectional responsibility over active pharmaceutical ingredient (API) manufacturers was reiterated. The agency did increase its inspection activity over firms that manufacture APIs and excipients. Additionally, FDA s review of foreign API manufacturers increased slightly. The onus, however, remains with the sponsor company to ensure that the manufacturer of their API is cGMP compliant and the material suitable for use. 

The firm could have prevented this situation and citation by ensuring that the appropriate person was responsible for communicating with the FDA s PAI manager to effectively schedule the inspection. The appropriate person is someone who has adequate interface with and information from the various departments, units, and personnel that need to be inspection-ready. Ideally, one individual is selected to communicate with various units within the company as well as the FDA. This person could be the PAI project manager or someone in the QA area. It is essential that this individual be apprised of the status of critical inspection activities, such as equipment qualification, process validation, and overall inspection-readiness. 

The inspected State Party shall designate the perimeter entry/exit points to be used for access. The inspection team and the inspected State Party shall negotiate the extent of access to any particular place or places within the final and requested perimeters as provided in paragraph 48 the particular inspection activities, including sampling, to be conducted by the inspection team the performance of particular activities by the inspected State Party and the provision of particular information by the inspected State Party. 

Figure 1. Schematic order of inspection activities related to sampling and analysis...

All documents related to and created during onsite sampling, sample splitting, sample preparation, and analysis are attached to the on-site analysis report (see below). The on-site analysis report is part of the report created by the IT concerning the inspection activities and subject to the same confidentiality regime as the report itself. Under no circumstances are any of these documents sent together with samples off-site. The on-site analysis report has to provide data to validate the method as well as the analysis result in accordance with OPCW procedures and the Quality System requirements. 

C-I/DEC.51, Measures in Relation to Approved Equipment Following the Completion of Inspection Activities, 1st Conference of State Parties, The Hague, 1997. 

Pharmacovigilance and inspection organization of procedures for effective surveillance (and possibly withdrawal) of medicinal products in the European Union, and to reinforce national inspection activities... 

In assessing whether and, if so, to what extent these requirements are fulfilled, the following elements seem relevant the kind of information that would be required to be provided when requesting an inspection how a decision on such a request would be made whether there is a right of refusal on the part of the challenged state whether there is any quota or limit to the request or receiving of inspections whether there are any restrictions in terms of specifying inspection sites the timeline between the decision to conduct an inspection and its actual implementation and the intrusiveness of inspection activities. 

As for the inspection activities under Articles IV and V of the Convention, the OPCW conducted over 2,000 inspections during its first eight years. During these years, the OPCW activities have expanded from verification of chemical weapons destruction to include a wide range of industry verification. 

The pace of destruction varies, of course, from one possessor State Party to another India is ahead of the schedule whereas, in 2003, the United States and the Russian Federation requested extensions of the deadlines for Category 1 chemical weapons stockpile destruction. It is noteworthy, however, that all such destruction efforts and inspection activities have been conducted safely and steadily without major accidents, let alone casualties. 

The inspection goal for a facility consists of a quantity component and a timeliness component (see Table 11.2). The quantity component relates to the scope of the inspection activities necessary in order to provide assurance that there was no diversion of a significant quantity (SQ) of nuclear material over a material balance period (MBP). The timeliness component on the other hand relates to the periodic inspection activities... 

The equipment used should provide the IAEA with an immediate capability to carry out also non-routine inspection activities. It is assumed that in the course of such inspections, it may be necessary to locate and identify nuclear-related materials, equipment, and activities. It would also be necessary to provide a clearly documented audit trail of the inspection times, locations, activities, and results. The equipment selected to provide this capability should meet the highest current standards for high measurement sensitivity, flexibility in use, portability, and quality. The equipment should provide, but not be limited to, the following functions ... 

The list is reviewed annually and equipment added or deleted based upon operational experience and new requirements or new equipment available. Presently the equipment needed for special and non-routine inspection activities is shown Table 11.5. 

Increased Co-operation The SSAC carries out activities that enable the Agency with States and SSACs to conduct inspection activities... 

The Agency and the SSAC may carry out selected inspection activities jointly... 

Part II sets up the procedures for on-site inspections. It specifies the process of designation of inspectors and inspection assistants, their privileges and immunities, points of entry, arrangements for use of non-scheduled aircraft, approved inspection equipment, on-site inspection requests, inspection mandate and notification of inspection. Pre-inspection activities and the conduct of inspections are described in detail. 

Figure 13.1 illustrates possible on-site inspection activities, including sampling, search for surface disturbances and underground voids, radioactivity measurements, seismic listening for residual cavity collapse activity and, in the extreme case, drilling down into a suspected test cavity. Inspections will serve as an important supplement to the international data networks. 

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