Documentation photocopying

The reports of the statutory inspections must be kept readily available for inspection by the enforcing authorities. Where needed as working documents, photocopies of the report should be used so that the original can be kept as a master copy in a central file. 

A copy of Form R is included in this booklet. Remove this form and photocopy as many copies of it as you need. Additional copies of ERA Form R and related guidance documents may be obtained from ... 

The kinds of resources needed are fairly straightforward. The primary resource requirement for most PSM implementation efforts will be staff-time, both professional and clerical/secretarial. It is also reasonable to expect to incur travel expenses at intervals throughout the process, especially for companies with multiple facilities. Support resources, such as telephone, computer time, facsimile, photocopying, and document production, will almost certainly be required in any initiative. 

Once the complete title is known, the journal can easily be obtained if it is in the library customarily used by the chemist. If not, one must use another library, and the next step is to find out which libraries carry the journal. CASSI answers this question too, since it carries a list of some 360 libraries in the United States and other countries, and for each journal it tells which of these libraries carries it, and furthermore, if the holdings are incomplete, which volumes of that journal are carried by each library. It may be possible to visit the closest library personally. If not, a copy of the article can usually be obtained through interlibrary loan. The CASSI also includes lists of journal publishers, sales agents, and document depositories. Photocopies of most documents cited in CA can be obtained from chemical Abstracts Document Delivery Service, Customer Services, 2540 Olentangy River Road, Columbus OH, 43210, USA. Orders for documents can be placed by mail, telephone. Telex, fax, or online through STN or other services. 

This document contains proprietary information which is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without the prior written consent of Hewlett-Packard. 

Almost all of the documents which are listed in the References and Abstracts section are available in full text form, as photocopies or pdf files from Rapra Technology Ltd s Document Delivery Service. Documents can be delivered by a variety of methods, including email, post or fax. Customers may pay for individual copies at the time of ordering by credit card or alternatively open up a deposit account. See the back of this report for further information. 

The whereabouts of original documents if only photocopies are available. 

As well as GCP site inspections, an examination is imdertaken of the raw or source data and records of Chemistry Manufacturing and Control (CMC), non-clinical and clinical reports that are the basis of the application. This is to ensure that the application dossier accurately reflects the source data. The procedure issued by PMDA details that list of raw data and records must be provided. The applicant is required to bring the data and records to PMDA on the specified days and when the examination finishes they should be retrieved. Therefore, the raw data and records stored at overseas sites are usually categorised as documents not to be submitted and not subject to reliability review by PMDA. Instead, the MHLW may investigate the data from non-Japanese studies at the site of storage since submission of a photocopy of the data is not permitted. 

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