Regulatory requirements meaning

In addition to regulatory requirements, the practical matters associated with maintaining product and personnel flow to and from operating facilities must be addressed. For example, it may be difficult to remove a rail spur for remediation of a contaminated bed, if the only means to deliver a feedstock into the facility or ship a product from the facility is this rail line. In-situ flushing or some other form of non-invasive treatment would be required to address such a problem. Similarly, jjersonnel access may have to be addressed in the planning for a corrective measures program. This is especially true in older or... 

Statutory and regulatory requirements are those which apply in the country to which the product or service is to be supplied. While some customers have the foresight to specify these, they often don t. Just because such requirements are not specified in the contract doesn t mean you don t need to meet them. 

Efficiency means carrying out regulatory responsibilities using as few resources (human, financial and time) as possible. Efficiency is also an issue in relation to the resources which the regulated parties must invest, and the opportunity costs they incur in conforming with regulatory requirements (i.e. in expending resources in that way, which cannot then be used for another purpose). 

European regulatory requirements are based on legal requirements, which are, in the pharmaceutical sector, now effected at the European level by means of Regulations (which are directly binding on the concerned parties) and Directives (which are binding on the member states to which they are addressed in terms of the effect to be achieved, but which allow a degree of freedom as to the precise method of national implementation) and in guidance (often included in... 

Periodic retraining will normally be required. Also, for some training it is important, or a regulatory requirement, to verify that the training was understood. Such means may include ... 

The future for production of natural flavors through the use of biotechnological means holds much promise. Researchers and industries interested in this exciting area however, will only be successful if they maintain an awareness of market trends, and of equal Importance, knowledge of regulatory requirements. 

Under the narrow interpretation of 21 CFR Part 11 as given in the FDA s latest guidance document,only those records come under the purview Part 11 are required by predicate rules. This means that the records have to mention, explicitly or implicitly, any of the sections of 21 CFR, which deal with GxP or regulatory requirements. Furthermore the new guidance document leaves the option open to define whether the paper or the electronic record is to be considered the official record. 

Hydrophilic and hydrophobic sterilization grade filters are used throughout the BFS process for the sterilization of product and air, respectively. Filters should be purchased from an approved supplier and should be certified as meeting the regulatory requirements for sterilizing grade filters. By definition this means that the filter will have full bacterial retention when subjected to an aqueous challenge of Brevundimonas diminuta (ATCC 19146) at a minimum concentration of 1 X 10 cfu/cm of filter surface area. 

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