Issue documents

Every business day there are more than 5000 research papers pubHshed and 1000 new patent documents issued. Analysis of these activities (52) can provide comparative indications of the impact, speed, science linkage, and technology linkage to firms around the world, adding an important element to strategic business and technology planning. 

NPDES Permit National Pollutant Discharge Elimination System permit is the regulatory agency document issued by either a federal or state agency which is... 

Users should be the prime participants in the preparation process so that the resultant documents reflect their needs and are fit for the intended purpose - hence the requirement that documents be reviewed as well as approved. You will need to be able to demonstrate that your documents have in fact been reviewed prior to issue. The presence of a signature on the front cover is not sufficient evidence. To demonstrate that documents have been reviewed you will need to show that nominated personnel have been issued with drafts for comment and that they have provided comments which have been considered by the approval authorities. A simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the review process you may undertake several revisions. You may feel it necessary to retain these in case of dispute later, but there is no compulsion for you to do so, providing you have evidence that the review took place. You also need to show that the current issue has been reviewed so your comment sheet needs to indicate document issue status. 

Customer engineering standards and specifications are external documents. Therefore your procedure for controlling external documents should also cover these documents. Where ISO/TS 16949 differs from ISO 9001 on this topic is that ISO 9001 does not require external documents to be reviewed or implemented. However, any external document received or procured for the organization should be reviewed for its applicability before it is brought under control, otherwise resources could be wasted on controlling documents that have no practical use in the organization. This requirement could be placed under Contract rev/ew since any documents issued by customers form part of the contract and should go through contract review before acceptance and implementation. 

In addition to the legal texts, you will also encounter guidance documents issued by the agencies involved in application and enforcement of legislation and other interested parties. 

Each working group has a corresponding chairperson who champions requests for proposals (RPPs) from any interested parties. The working group members identify key needs and help with the building of RPPs from a boilerplate standard document issued by the OMG. Anyone can submit a letter of intent (LOI) to respond to a RPP however, to become a submitter, the... 

ASME accepts responsibility for only those interpretations of this document issued in accordance with the established ASME procedures and policies, which precludes the issuance of interpretations by individuals. 

The management system should specify documentation requirements for interim data and work products of the investigation. The company s legal staff may have a valuable opinion on this decision or they may offer case-by-case opinions. Several issues are obvious. Witness interviews and physical evidence are examples of notable issues with which the legal department may wish to he involved. Other important documentation issues include ... 

All documents Issued to personnel In the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to Issue. 

Documents issued to casual users who will only use them for reference, e.g., a purchaser, client, or customer, are clearly distinguished from those issued for the controlled copy circulation as they need not be kept up to date. They are marked uncontrolled copy (will not be maintained), this copy will not be kept up to date, or check for latest issue before use. ... 

An overview of regulatory and industry GMP documents issued before 1990 and their inclusion of validation elements is shown in Table 1. 

Take notes. When people make suggestions or you make promises, write them down. Provide a deadline for getting back to them about any documented issue. Then keep your promise to get back to them by that deadline. 

INDs Review of Informed Consent Documents (Issued November 13,2002)... 

This guidance document is being distributed for comment purposes only. Document issued on October 26,2006. 

Tandem mass spectrometry is considered as necessary to provide unequivocal identification and quantification of analytes, as pointed out by Maralikova et al. [70], It is also clear that monitoring of a single transition could lead to false compound identifications [71]. This had been previously predicted in the 2002 document issued by the European Union Commission that contains detailed information about mass spectrometric identification of drug residues in foodstuffs [57], where a minimum of three so-called Identification Points (IPs) is required for compound identification. 

In the context of the guidance documents issued by the FDA, this chapter has explored the various issues, and described a number of recommendations, con-... 

Certificate A document issued to a pharmacist on successful completion of the predetermined level of performance of a certificate training program or of a pharmacy residency or fellowship. 

Reference material, accompanied by documentation issued by an authoritative body and providing one or more specified property values with associated uncertainties and traceabilities, using valid procedures. 

SUPAC-MR Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes Chemistry, Manufacturing and Controls In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/97, Manufacturing Equipment Addendum Issued 1/1999). 

Additional Large Scale Process Qualification Studies Product Transfer Document Issued Product Acceptance by Manufacturing Validation Protocols Written Pre-approval Inspection Task Force Initiated Manufacturing Site Preparation Pre-approval Inspection by FDA... 

Selected U.S. Government Publications. This guide announces selected publications that are maintained in GPO stock and available directly from the Superintendent of Documents. Issued biweekly, it appears in leaflet form with annotations and prices. It is available free from GPO. 

Checklist. This volume contains brief descriptions of all documents issued by the U.S. Government from 1789 to 1909, listed by cla. sification number. The Checklist can be consulted at most libraries, but is available in reprint from J. W. Edwards, Publisher, Inc., Ann Arbor, Mich. 

The beneficiaries of the special reimbursement regime referred to in No. 1 above must prove their eligibility by means of a document issued by the competent official authority. 

Document issued by the relevfmt health authority certifying that the product is registered or allowed to be sold in the country of manufacture unless otherwise waived... 

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