Inspection authority - meaning

Although written reports are the inspecting authority s end product they by no means comprise the whole of the professional service that is supplied or is available on request. The authority s quality assurance objective is likely to be on the lines of client satisfaction allied to compliance with contractual obligations . Although reports are almost certainly monitored, they are a poor indicator of the quality of the examination, and the authority s quality control will rely less on report... 

The inspection and test status of the product or parts are clearly identified by marking, tags, labels, inspection records, test reports, shop travelers, physical location, or other suitable means that indicate the conformance or nonconformance of the product. Records show the inspection authority that determined the status. 

Two types of models are used to quantitatively describe the SPMD-water exchange of hydrophobic organic chemical (HOC) solutes. These models can easily be inter-converted, and differ only in the definition of the rate constants used. The fact that various authors have used the same symbols to denote different kinds of rate constants is a complicating factor that requires a careful inspection by the reader to delineate the meaning and assumptions of the respective authors. 

Calibration inspection refers to comparison with a standard in accordance with certain statutory regulations by specially authorized personnel (Bureau of Standards). If the outcome of this regular inspection is positive, an operating permit for the next operation period (e.g. three years) is made visible for outsiders by means of a sticker or lead seal. If the outcome is negative, the instrument is withdrawn from operation. 

Closer inspection reveals that this somewhat superficial and largely self-evident evaluation is by no means exhaustive, and concrete experimental studies on adsorptive reactors expose both additional pitfalls and benefits that are often specific for a particular reaction system and decisive for the success or otherwise of adsorptive reactor concepts. Before illustrating this point with the help of four examples with which the author is personally acquainted - the Claus reaction, the direct hydrogen cyanide synthesis from ammonia and carbon monoxide and, to a lesser extent, the water-gas shift reaction and the Deacon process - it is worthwhile briefly reviewing other reaction systems for which the potential of adsorptive reactors has been examined (Tab. 7.2). 

Records that can be immediately retrieved by computer or other electronic means should be readily available for inspection during their retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request by an authorized official. 

A requirement, in line with Regulation (EC) No 1935/2004, concerning a declaration of compliance and the availability of appropriate documentation, has been confirmed in the draft regulation. It means that for any active and intelligent material a statement shall be provided that certifies that the material is safe to be used in contact with food under specified conditions of contact. To support such a statement the certifier shall have documentation that can prove the validity of the certificated. These documents shall be available to relevant authorities for inspection. In many cases this will include analytical data on, e.g., migration, total release, and effectivity of the active and intelligent of active components. 

In some cases, the information obtained from an inspection may lead the Local Authority to the conclusion that, whilst the land does not appear to be Contaminated Land on the basis of that information assessed on the balance of probabilities, it is still possible that the land is Contaminated Land. This might occur, for example, where the mean concentration of a contaminant in soil samples lies just below an appropriate guideline value for that contaminant. In cases of this kind, the Local Authority will need to consider whether to carry out further inspections or pursue other lines of enquiry to enable it either to discount the possibility that the land is Contaminated Land, or to conclude that the land does appear to be Contaminated Land. In the absence of any such further inspection or enquiry, the local authority will need to proceed to make its determination on the basis that it cannot be satisfied, on the balance of probabilities, that the land falls within the statutory definition of Contaminated Land. ... 

The manufacturer must carry out on-going real-time stability studies to substantiate the expiry date and the storage conditions previously projected. The data needed to confirm a tentative shelf-life must be submitted to the registration body. Other results of ongoing stability studies are verified in the course of GMP inspections. To ensure the quality and safety of products with particular reference to degradation, national health authorities should monitor the stability and quality of preparations on the market by means of a follow-up inspection and testing programme. 

The quality control system adopted by every production establishment shall be developed through a Quality Inspection Department which will function under the supervision and/or responsibility of a pharmaceutical chemist. This professional shall be invested with the necessary authority and means to be able to carry out his task efficiently, to this end being independent of the other departments and responsible to the administration of establishment, without prejudice to his responsibility to health authorities in accordance with the provisions of the present regulation. 

All records required in this section, or copies of such records shall be made readily available for authorized inspection by the Ministry of Health personnel. These records or copies shall be subject to-photocopying or other means of reproductions as part of an inspection. 

All records or copies of such records should be readily available for authorized inspection and copying by FDA during the retention period at the establishment where the activities described in such records occurred. Records kept off site should be promptly retrievable by electronic or other means. 

---