Competence authorised persons

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... 

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

Obviously authorised persons are in positions of considerable responsibility - they make systems safe for others to work on them and they therefore need to be conscientious and thorough, and these traits are essential elements of their overall competence. Any mistakes can have serious consequences, especially where high voltage work is concerned. There has been a small... 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

This latter operation has now been completed for approximately 90 percent of MAs. PlLs have now been approved for most authorised medicinal products. The holder of the MA is also required to employ a person who is competent to take full responsibility for compliance of the information and publicity with the regulations and for consistency with the data sheets and patient leaflets accepted at (re)registration. This person has to be a registered pharmacist or physician. For veterinary products this can also be a veterinarian. 

In exceptional circumstances, such as the first production runs following pilot development, the master formula might need to be amended. Any amendments must be formally authorised and signed by competent persons. The amended document should be replaced at... 

Manual control of a pressure cooker is not realistic and GMP compliant in practice because it does not result in a reproducible process. Moreover incidental manual control by an operator is only allowed with the authorisation of a competent person. GMP compliant autoclaves are entirely computer-controlled using multiple pressure and temperature sensors. Processes for control and operation administration are validated. 

The work activity includes operation, use and maintenance. Those responsible for the work, and those engaged in it, need to be competent to appreciate the electrical hazards and the control measures needed to minimise the risks to an acceptable level these issues are addressed in Regulations 14 and 16. To this end, the person responsible for managing the work should consider the work activities, the risks that arise, the measures that should be taken to control them, and who should be allowed to perform them. If, for example, work has to be done on a low voltage system which necessitates it being made dead , the supply to it needs to be isolated, the isolator locked off and a test made to prove that the isolated part is indeed dead and therefore safe to work on. Anyone authorised to carry out these safety precautions has to be familiar with the system, knowing which isolator or isolators to open and lock off and how to apply the test. The responsible person should also ensure that those who do the work have appropriate technical knowledge to do it properly and, on completion, to test it to prove its safety. 

The safety philosophy is based on dividing the site installation into two distribution systems the 400/230 V system where there is a comparatively high shock risk because the voltage to earth is 230 V, and the comparatively safe 110 V system where the voltage to earth does not exceed 64 V. The 400/ 230 V system is intended to be installed and maintained only by authorised and competent persons, i.e. those who are electrically qualified. The construction workers role is confined to operating the distribution equipment, which is metalclad, weatherproof and earthed. The portable apparatus which they constantly handle is all connected to the llOV system (see Fig. 11.1). 

The electricity supply companies generally use single-core PVC-insulated and sheathed conductors without further protection for the connections between their cut-outs, metering equipment and the consumer s main switchfuse or circuit breaker, and very often this wiring is not properly secured. It is not, therefore, as safe as the site installation wiring, so access to it should be restricted to authorised and competent persons. Any building or... 

Hoist drivers must be authorised, trained and competent. Persons making inspections and signing for weekly inspections must be trained and competent to do so. 

Only authorised, experienced and competent persons should carry out pressure testing. Work must be controlled, preferably by a permit-to-work system. The manager or supervisor must carry out an inspection of the system before starting the test, to ensure that isolations, blanks and other specified safety devices are in place before any testing begins. 

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