Inspection facility-based

Facility-based, that is, to inspect the whole facility whether it meets the GLP requirements,... 

This latter point might best be illustrated by the case of the Quality Assurance SOP on inspections. Quality Assurance has the possibility to perform facility-based, study-based and process-based inspections, as has been described in detail in section 4.2 (see page 138). In writing the respective SOPs, it will be insufficient, however, to provide only a description on how such inspections will be performed. This is to say that describing the standard way of performing these inspections will only represent one part of the necessary information to be given in these SOPs. As important as the how should be the when . Thus, the respective SOPs of the Quality Assurance will have to consist of the following parts ... 

Applicability Facility-based inspections will be performed at regular intervals of about x months independent of specific studies. Study-based inspections wiU be performed within the time limits specified by the master schedule and the single inspections will be set according to the defined critical phases of the studies. Process-based inspections will be conducted at regular intervals (of about x months, or for each yth study) for those study types that fulfil the following conditions ... ... 

A description of the potential hazard and recommended actions to be taken by emergency and firefighting personnel dnring a fire or explosion event for a specific hazard, location, or facility based on previons inspections and surveys of identified hazards. Pre-fire plans note the structural features, physical layout, special hazards, installed protection systems, fire hydrant locations, water supplies, and similar features pertinent to firefighting operations. Pre-fire plans should be routinely updated or revised as changes occur in a facility or location. 

In the first two years of on-site OCPF inspections (2000 and 2001), a two-step selection methodology was applied (EC-XIX/DEC/CRP. 11, dated 4 April 2000). In the first step, the State Party was selected. In the second step, the plant site within the State Party was selected, based on its range of production (irrespective of whether it contained PSF plants or not) and whether it had aheady been inspected in the past. During the first year of implementation, the State Party was selected with a probability proportional to the cube root of the number of its declared inspectable facilities. From November 2001 onward, the Secretariat attempted to broaden the geographic distribution of inspections by selecting with equal probability the States Parties to be inspected. 

Decides that, when planning the number, intensity, duration, timing, and mode of inspections of Schedule 1 facilities, based on the risk to the object and purpose of this Convention posed by the relevant chemicals at SSSFs or quantities of chemicals produced thereof at other Schedule 1 facilities, the characteristics of the facility and the nature of activities carried out there, the Secretariat should take into account the relevant approved facility agreement relevant declarations and inspection findings and any relevant decisions of the Council or the Conference ... 

The use of IP can enable the NR and neutron imaging in general with rather low intensity neutron beams which is Of importance both for neutron beam research as well as for extending NR for the in-the field use in the industry. With the existing reactor based neutron facilities the use of IP can drastically reduce the inspection time ... 

The manipulator is equipped with a vertical movement to utilize the in-built magnification facilities that come with the image intensifier based imaging system to assist in inspecting and classifying a block. 

The laser-based gun tube inspection systems are intended to augment and, perhaps eventually, replace the labor-intensive, time consuming and subjective visual inspection methods that are currently employed by these facilities. 

Unseen corrosion can be the most damaging type of attack. Items should be designed to permit periodic inspection. This involves the provision of sufficiently large manways, the installation of inspection pits, the placing of flat-bottomed vessels on beams instead of directly onto concrete bases and the facility for removal of thermal insulation from vessel walls. 

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

Regulatory authorities inspect GMP facilities to ensure compliance to GMP. The FDA carries out surveillance and compliance inspections. A system-based approach is adopted quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. Deficiencies are reported on Form FDA-483, which may lead to a warning letter and consent decree if unresolved. 

The proposed CLP regulations announced that based on the requirements of the proposal, the FDA would conduct a number of surveillance inspections of testing facilities during No-... 

The audit was divided into two parts (1) General QA Practices and (2) Data Audit. A questionnaire as used by EPA s Office of Pesticide Programs, Quality Assurance Office, for Internal Audits, was employed. A copy of the completed questionnaire is(not) attached. From discussions, based on the questionnaire and observations made during inspection of the facilities and from a data audit, a subjective summary regarding... 

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... 

For the last 70 years or so the chemical industry has been based on crude oil (petroleum) and natural gas as basic raw materials, hence the name petrochemicals. This may not be so for much longer, however. The chemical industry is currently on the brink of a new revolution, based on the switch from fossil resources to renewable agriculture-based raw materials. From a distance the production facility of Cargill in Blair, Nebraska looks very much like a small oil refinery or medium-sized petrochemicals plant. However, closer inspection reveals that it is a corn-processing plant a biorefinery producing, inter alia, high-fruc-tose corn syrup, ethanol and lactic acid. As James R. Stoppert, a senior executive of Cargill pointed out, the chemical industry is based on carbon and it does not matter if the carbon was fixed 2 million years ago or 6 months ago [1]. 

---