Authority approval

Ensure tanks are certified by competent authority/approved person. 

Although the standard does not recognize any classification of nonconformities, the practical application of nonconformity controls requires controls to be balanced with the severity of the nonconformity. It is not necessary to seek concessions from a customer against requirements that have not been specified, or seek design authority approval for workmanship imperfections. The definition of the term defect in ISO 8402, and the fact that there are many requirements other than those specified in a contract or needed to satisfy market needs, demands that it is sensible to classify nonconformities into three categories ... 

Minimum capacity of 27001 to be provided. Subject to local authority approval, the effluent output from a septic tank may be connected to an adopted sewer subject to quality of output and size and location of drainage. 

Cognitive effects Humans with dementia Several studies have looked at the effects of ginkgo extracts on cognitive function in people with dementia. German health authorities approved a ginkgo extract in 1994 for treatment of primary degenerative and vascular dementias (Itil et al. 1998). 

Mr L.H. Eriksen, Feltman Research Laboratories Director, Picatinny Arsenal, has authorized approved this project. It is thru his interest, encouragement guidance that this publication is possible. The support of this project by Dr J.V.R. Kaufman, US Army Material Command Deputy Director for Plans, AMCRD, is also gratefully acknowledged. This Encyclopedia was prepared by scientists assigned to the Explosives Laboratory of FRL, Dr R.F. Walker, Chief. All reference works used, such as reports, periodicals, journal books, were made available thru the cooperation of the Scientific Technical Information Branch personnel,... 

Mr L. H. Eriksen, Director, Feltman Research Laboratories, Picatinny Arsenal, has authorized approved this project, and thru his interest, encouragement guidance this publication is possible. This Encyclopedia was prepared by personnel assigned to the Explosives Laboratory of FRL, Dr R. F. Walker, Chief. 

Reference with numbering system, date, and signature of author, approvals with sign and date of user, engineering, and QA. 

Supportive documentation should be added to the report, such as equipment and facility drawings, technical and other specifications, test methods, suppliers certificates, health authorities approvals, approvals of components, and raw data results. 

Corresponding investigational newdrug (IND)/NDA/ANDA number, if applicable Name of author Approval signatures and dates... 

Verification of approved manufacturing process changes to marketing authorizations/approved applications [24]... 

The system manipulates data, or produce reports, to be used by quality related decision authorization/approval processes... 

Electronic Signatures — When should these be used (for instance, at the point where a record is authorized/approved or is captured in a regulatory document such as a batch record) ... 

Notes (1) For Type B, under the UN Recommendations on the Transport of Dangerous Goods, Model Regulations, special provision 181 may apply (Exemption of explosive label with competent authority approval. See Chapter 3.3 of UN Model Regulations for more details). 

Other countries have followed the U.S. lead regarding patent term extension. Japan enacted a provision effective January 1, 1986, whereby patents covering pharmaceutical products could be extended for up to 5 years. The Japanese provisions differ from the U.S. law in several ways. First, more than one patent can be extended for each product. Also, the Japanese law requires that the patent be granted 2 years before health authority approval of the product. Korea has enacted a patent term extension law very similar to that in the Japanese system. Australia has replaced its lack of renumeration system with a system based on regulatory delay. 

In Norway, Wieders Farmasoytiske A/S received approval for the use of NIR as an alternative method for identification, assay, and determination of moisture content of paracetamol (acetaminophen) tablets. The Norwegian Medicines Control Authority approved the method in December 1996. 

Test Sensitivity Detection range Speed Cost/test, excluding staff time Regulatory authority approval Special equipment requirements... 

Fifteen samples of packaging material (labeling needs health authority approval, leaflet should be in Arabic and/or English)... 

September 16, 1985, 227 USPQ 90). The Court reversed the Patent and Trademark Office indicating that a deposit in a public depository is not required at the time of filing a patent application.) The deposit must be made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. Clearly, any International Depository Authority approved by the World Intellectual Property 0rganl2ation under the Budapest Treaty... 

Many of the issues mentioned in this section put requirements on the attributes used to characterize the individual documents. In the paper-based world, it is comparable to the content of letterheads, page headers and footers and so on that are standardized for each document and across documents. Thus, it must be decided what the characteristics of each document type will be, including, for example, document title, author, approvers, dates, status, version, language and so on. 

Progress in the development of nano-sized hybrid therapeutics and nano-sized dmg delivery systems over the last decade has been remarkable. A growing number of products have already secured regulatory authority approval and, in turn, are supported by a healthy clinical development pipeline. They include products used to treat cancer, hepatitis, muscular sclerosis, and growth hormone deficiency. (See Therapeutics Packaging and Nanomedicines in Chapter 7.)... 

---