Approved meaning

Ductwork shall be designed to facilitate dismantling and to minimize the release of contamination to adjacent areas with bagging or other approved means. 

The investigator should be aware that the interval for IRB review can be more frequent than once per year. If an investigator allows an IRB approval date to lapse, the research no longer has IRB approval. No approval means that the research must stop. Extensions of approvals do not exist. Investigators should provide the IRB with an adequate detailed report in a timely manner to avoid the approval of their study from expiring. 

Any opening in a fire barrier is a potential weak point. It is advisable to minimize the number of openings. All openings in fire barriers should be provided with fire door assemblies, fire dampers, penetration seals (fire stops), or other approved means having a fire protection rating consistent with the designated fire resistance rating of the barrier. 

When Phase 1 -3 clinical trials are completed, the developer files a New Drug Application with the FDA, which contains the data on the drug that have been collected so far. The FDA has up to six months to act on the application if the drug is approved or determined to be safe and effective, then the developer may market the drug within the United States and may export the drug for sale outside the United States. Anything less than approval means more time must be spent to correct deficiencies or solve problems so that a new application for approval may be filed. 

Who approves a procedure and what that approval means are important to your procedure system. Typically, the approver puts his or her signature on the document to verify that the procedure has been drafted and reviewed according to the site s system and that the procedure is the standard for performing the task until the next revision. 

Approved means the equipment is listed by a nationally recognized testing lab such as Underwriters Laboratories (UL), or a federal agency such as the Bureau of Mines, or the Coast Guard. 

Fittings like separate drain valve for each compartment, safety valves, earth connection by hanging chains/other approved means by statutory authorities, vent valves and arrangements with air compressors for completely emptying out the contents should be provided on the tankers. 

Grounding by attaching the device enclosure to the machine with bolts or other approved means shall be considered satisfactory if all paint and dirt are removed from joint surfaces. Moving machine parts having metal-to-metal bearing surfaces shall not be considered as a grounding conductor. 

Emergency notification, equipment, personnel, evidence that equipment and personnel are available (by contract or other approved means), and evacuation information ... 

These costs and delays are passed on to the food producer or processor as well as the consumer. New products become more costly and the reduced pace at which new pesticides are approved means that some producers will be unable to obtain pesticides to meet specialized needs. Such specialized needs are met by a USDA program that assists in registering pesticides for "minor uses". University and government laboratories are obtaining residue data that will allow the manufacturer to add additional uses to the product label. 

At the European level, the national organizations from both the EU (European Union, formerly the EEC) and the EETA (European Free Trade Association) are grouped in the CEN (European Committee for Standardization) and its counterpart for the electrical industries CENELEC. The standards published by these two organizations have authority in all EU countries as well as the EFTA countries who have voted their approval, which means that these standards have replaced their corresponding national standards. 

Two main types of harmonised standards can be distinguished the product standards and the horizontal standards. The latter, as their denomination indicates, contain issues of a horizontal nature, e.g. for materials or provisions relating to welding or welder approvals. These standards should be formulated in such a way as to be self-sufficient. That means it should be possible to apply them without having to use individual product standards. 

The results of corrosion surveys are received by the Surveyor in an agreed format using Forms TMl - TM8, preferably with the LR software freely issued to the approved firms. The report will highlight any areas where corrosion has gone beyond the permitted maximum diminution, which may be as low as 15% of the nominal thickness for a single item, and will also identify areas of "substantial corrosion T.e., any in excess of 75% of the permitted maximum. Corrosion in excess of that permitted means that the item has to be replaced. Any areas of corrosion deemed to be "substantial" are recorded for annual inspection. The Surveyor will review the completed report for verification and confirmation of the completeness of the thickness survey. 

The term issue in the context of documents means that copies of the document are distributed. You will of course wish to issue draft documents for comment but obviously they cannot be reviewed and approved beforehand. The sole purpose of issuing draft documents is to solicit comments. The requirement should be that the documents are reviewed and approved prior to use. Some organizations insist that even drafts are approved for issue. Others go further and insist that copies cannot be taken from unapproved documents. This is nonsense and not what is intended by the standard. Your draft documents need to look different from the approved versions either by using letter issue notation (a common convention) or by printing on colored or watermark paper. If the approved document would carry signatures, the absence of any signature indicates that the document is not approved. 

This requirement does not mean that you need to maintain a list of approved suppliers. You should monitor the performance of all your subcontractors and suppliers and classify each according to prescribed guidelines. It is equally important that you list those... 

The standard also requires that the instructions be derived from appropriate sources, such as the quality plan, the control plan, and the product realization process, which means that all instructions should be traceable to one or more of these documents. They should form a set, so that there are no instructions used outside those that have been approved by the planning team. This is to ensure that no unauthorized practices are employed. Another important aspect to consider is the use of informal practices - practices known only to the particular operator. Process capability should be based on formal routines, otherwise repeatability cannot be assured when operators change. 

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

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