Persons authorised

This Accessible Digital Copy is for the personal use of an "Authorised Person" who is defined as "a pupil who is visually impaired or otherwise disabled and by reason of such visual impairment or disability is unable to read or access the original printed book". 

An Authorised Person is regarded as "visually impaired" in accordance with S.31F (9) of the Copyright, Designs and Patents Act 1988, or, as appropriate, as a "disabled person" in accordance with s.l of the Disability Discrimination Act 1995. 

The name of the medical practitioner or other authorised person who made out the prescription and, where applicable, the name of the clinic concerned. 

The person participating in a trial must consent to the scrutiny of personal information during inspection by competent authorities and properly authorised persons, provided that such personal information is treated as strictly... 

Forensic laboratories use the system of chain of custody to demonstrate in court that the samples have, at all times, been held securely by authorised persons and that no tampering with the evidence has taken place in the laboratory. In addition, it is essential that one can demonstrate that the results of the analysis relate to the correct sample and that it can be traced back to the suspect or the site from which it originated. 

Exception is made to the provisions of the previous paragraph for those radioactive drugs prepared at the time of use and in accordcince with the manufacturer s instructions, by authorised person or institution emd exclusively from authorised generators, inactive kits or precursors. 

If the holder of the authorisation personally meets these requirements, he may also carry out the functions of technical supervisor. 

A record of the destruction would need to be made in the controlled drugs register (see Section 6.3.7) and be signed by the authorised person. 

Isolation does, however, not mean that access to the test system or their housing or treatment localities generally needs to be restricted, save in some special circumstances, and apart from what would be dictated by sound scientific reasons. An example in case would be the restrictions for the access to certain animal facilities Because of special requirements, e.g. because of a specific pathogen-free or even sterile environment, access to these may have to be limited to authorised persons only. 

The first of these measures is the already mentioned limited access to the archives. Only those individuals authorised by management should have access to all archive locations. This translates into the requirement that only a limited number of keys should be available for the archive facilities, all of which should be securely kept, allowing only the authorised persons to use them. It has to be recognised, however, that for cases of an emergency, like fire or a leaking water pipe, threatening the archive and its contents, a reserve key should be placed with the technical department in the test facility. 

AUTHORISED PERSON Person recognised by the authority as having the necessary basic scientific and technical background and experience. 

Key personnel include the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorised person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2.5,26 and 27. 

Documents should be approved, signed and dated by appropriate and authorised persons. 

Written release and rejection procedures should be available for materials and products, and in particular for the release for sale of the finished product by the authorised person(s) designated for the purpose. 

Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The contract must clearly state the way in which the authorised person releasing each batch of product for sale exercises his full responsibility. 

The Contract Giver should ensure that all processed products and materials delivered to him by the Contract Acceptor comply with their specifications or that the products have been released by an authorised person. 

A person should be designated as responsible for execution and coordination of recalls and should be supported by sufficient staff to handle all the aspects of the recalls with the appropriate degree of urgency. This responsible person should normally be independent of the sales and marketing organisation. If this person is not the authorised person, the latter should be made aware of any recall operation. 

When the release of batches for sale or supply is carried out using a computerised system, the system should recognise that only an Authorised Person can release the batches and it should clearly identify and record the person releasing the batches. 

When products must be dispatched before all tests are completed, this does not reduce the need for a formal recorded decision to be taken by the Authorised Person on the conformity of the batch. In this case there should be a written procedure detailing all production and Quality Control data which should be considered before the batch is dispatched. A procedure should also describe those measures which will be taken by the Authorised Person if unsatisfactory test results are obtained after dispatch. 

Security arrangements should prevent the coupling of bulk tankers to receival points except by or under the supervision of an authorised person. 

Labels and other pre-printed packaging materials, including APPROVED status labels, should be stored in a secure manner that will permit access by and issue only to authorised persons in accordance with documented procedures. 

Starting Materials should be issued from stores only by authorised persons, following a standard operating procedure. 

Starting materials should be dispensed only by authorised persons, following a standard procedure which ensures that the correct marerials are accurately weighed or measured. Scales and measues with accuracy appropriate to the various quantities to be dispensed should be available. Each dispensing operation should be checked and the check recorded (see Clause 545). 

The records may be certified at intermediate stages by authorised persons for completeness, conformity to standards for yield and in-process tests and conformity to final specifications. The final examination and evaluation of the consolidated records, however, should remain the responsibility of Quality Assurance. 

The entry of critical data into a computer by an authorised person (e.g. entering a master processing formula) should require independent verification and release for use by a second authorised person. 

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