Standards harmonized

The conference endorsed the goals of the pharmacopeias to improve and harmonize standards for existing excipients, to focus on testing methods, and address specifications after test methods had been agreed upon, and to develop functionality tests, including particle size, siuface area, and density. 

The pharmacopeias have worked with the ICH process to facilitate the international environment of pharmaceutical research and product registration. On the other hand, the additional situation for compendia is that the standards which they have published now apply to all of the already marketed products. In that case a company has testing history and product history in their quality control departments. These are the most conservative elements within the pharmaceutical industry as is necessary to their task. Quality control departments are reluctant to change methods when they feel that their products are properly represented by the current of tests. Therefore, a tension is ereated between trying to develop harmonized standards, which facilitate one area of activity in the world of pharmaeeutieals, and not disturbing a satisfactory marketplace. A vast amount of progress has been made in the harmonization of phar-maeopeial methods. 

This "new" approach has been in use for many years in most European countries. Originally, each country had their own national requirements. Then, based on the work done by the lEC (International Electrochemical Commission), standards were harmonized through the work of CENEEEC (Comity Europ en de Normalisation Electrotechnique). Harmonized standards, published as European Standards (EN), have to be adopted by the participating countries as national standards. Some of the countries which have already adopted these are Belgium, Erance, Germany, and the United Kingdom. 

In the case of multiple valves, only one valve needs to be set at no more than MAP. The others can be set up to MAP +5% (inclusive). In any case, the required capacity must always be relieved at no more than MAP +10%. As taken from the harmonized standard EN 764-7 paragraphs ... 

The PED is a legal requirement - failure to comply is a criminal offence. Products manufactured as per the harmonized standards are presumed to conform to the Directives and can carry a CE mark. 

Be subject to a European approval for materials by a notified body (only if not covered by the harmonized standard). 

Globalization, harmonization, standardization, uniformity, and mutual recognition agreements are all prevailing trends that significantly affect compliance in the pharmaceutical, medical device, and biotechnology industries. 

A new ISO Committee, Technical Committee 210 (TC-210) is developing harmonized standards in these areas. Also, the CDRH is an active participant in the Global Harmonization Task Force, in cooperation with officials from Canada, the EU, Japan, and other countries. 

A European Standard for Continuous Laminate is being developed within CEN Technical Committee 249 but at the time of writing there have been no proposals to harmonize standards for Direct-faced or Composite Boards. 

One important consequence of the Committee s failure to make progress is that the existing Standard (Joint FAO/WHO, 1993) remains in place and will be the reference used by WTO in any trade dispute. This text is very out of date and revised provisions are needed urgently in order to ensure consumer protection and to facilitate fair trade. It is thus important that the European Commission and the IOOC harmonize their rules and that agreement is reached on the Codex text when it is discussed again at the 18th CCFO session in 2003. In this respect, a commitment was made by the European Commission to the Council to work constructively with the IOOC in order to harmonize standards (Council of the European Union, 2001). 

Harmonize standards for the production, processing, handling, labelling, and certification of organic plant and animal products. 

Harmonization is not a one-time event, and it does not imply superimposability of texts. Residual disharmony can exist at the end of any specific attempt to harmonize standards. Iterations of harmonization, already evident, will be the norm in the future. Refer to the PF as the essential source of any future understanding or tracking of harmonization topics or sequences. 

Although diligent effort was made to use as recent compendial information as possible, compendia are frequently revised and the reader is urged to consult current compendia, or supplements, for up-to-date information, particularly as efforts are currently in progress to harmonize standards for excipients. 

CE mark signifying compliance with EU harmonized standards and directives... 

Procedures/responslbllltles the CER includes a section on the Management of Production Activities . This states that To apply the eight guiding principles of its Responsible Care policy, Solvay is introducing harmonized standards and methods. ... 

When a S-f symbol contains an odd F an odd number of times the corresponding integral vanishes because of its ungerade character. So in this case one of the F s must be represented by a corresponding axial operator (and the others still by their spherical harmonic standard basis functions) in order that the 3-r symbol can be represented by an integral. The 3-F symbol defined in this way will then automatically change sign under odd permutations of its columns, so we have an odd 3-F symbol. 

Not only the data obtained by harmonized standards are used, several simple data input and measurements will be required. The study indicates ... 

Setting up proper risk assessment procedures and applying them to the change control process markedly reduces the efforts required to keep systems in a validated state. Harmonization, standardization and efficiency can be increased by appointing a company computer validation committee per site and/or at a corporate level. Good cooperation between QA and IT is a prerequisite for keeping systems validated. 

The various international standards organizations (e.g.. the ISO, lEC. IMO. CEN. CENELEC) develop harmonized standards, but in addition to this formal standards... 

The expectations to new technology are of course comparable to already introduced and accepted technical solutions. This is especially true for on-road safety standards. Fuel cell vehicles are developed, tested and certified, equally to the conventional vehicle according to actual standards and regulations. The challenge is to provide harmonized standards and regulations in all relevant markets for all the fuel cell specific requirements. 

Discussion of compliance with European harmonized standards—This is the most important element to meeting the ERs of the directives. Products manufactured in conformity with harmonized standards are presumed to conform to the ERs of the directives. 

Directives are the European laws published in the Official Journal that give us the essential health and safety requirements (EHSRs) that shall be followed by product suppliers. These are commonly called the Essential Requirements (ERs). The directives deal with legal and procedural issues, such as assessment procedures, certification, implementation, enforcement, technical files, declarations, CE marking, and other basic concepts. Examples of primary directives are the Low-Voltage, Machinery, and EMC directives. The General Product Safety and Product Liability Directives are basic directives dealing with enforcement and civil prosecution that are applied to all products. The directives also mandate the publication and mutual recognition of harmonized standards. 

Presumption of conformity is a phrase associated with products that comply with all aspects of the relevant European harmonized standards. National enforcement authorities are obliged to recognize that equipment manufacmred in conformity with the harmonized standards, published in the Official Journal and transposed into national standards, are presumed to conform to the essential requirements of the directives. When a product is not in compliance with the appropriate European standards, the equipment will not benefit from a presumption of conformity conferred by the use of such standards. 

Evaluation of conformity is an assessment and is the systematic review to which a product, or system, fulfills specific requirements (i.e., harmonized standards). A mandatory assessment according to all the requirements must be undertaken and documented in the manufacturer s technical file before anyone can affix a CE marking and place a product on the market, make it available, or put it into service. 

As an example of standards history and progression, the German ITE safety standard DIN VDE 0805 became EN 60950 (lEC 950), machine safety standard DIN VDE 0113-1 became EN 60204-1 (lEC 204-1), machine EMC standard DIN VDE 0875 became EN 55011 (CISPR 11), and appliance EMC standard DIN VDE 0875-1 became EN 55014 (CISPR 14). Except for EMC immunity, the majority of European product safety, machinery, and EMC standards are traceable back to their German standards origin. Thousands of German standards (DIN, VDI, VDE, VBG, ZH, etc.) form the basis for the newer harmonized standards (EN, lEC, etc.). 

Products must conform with the Essential Requirements (ERs) of all relevant directives before being placed on the market. ERs are at the center of European law and standards and are retained for the presumption of conformity by virtue of their publication in the directives as harmonized standards. The ERs and harmonized standards include the requirements to protect consumers, health, merchandise, and the environment. The transposition of the European directives and harmonized standards into national laws and standards makes them legally binding and obligatory in the member states. Products that conform to the European harmonized standards are presumed to comply with the essential requirements of the directives. 

CE Marking Directive 93/68/EEC states that the choice of conformity assessment procedures must not lead to a lowering of safety standards of electrical equip-ment/products, which have already been established throughout the Community. Alternatives to European standards are possible in the case where no European harmonized standard exists. Conformity to International standards (i.e., lEC) or European national standards (i.e., DIN, BS, NF) is sometimes an acceptable alternative, but in this case the manufacturer must be able to demonstrate conformity with the ERs of the directives and at the same time not fall below the minimum acceptable criteria. The General Product Safety Directive 92/59/EEC allows the use of EU national standards when no European harmonized standards exist. This alternative may be needed as a transitional measure until a European standard is published (see General Product Safety in Chapter 2). This approach is not recommended when European harmonized standards exist, especially if a product becomes suspect, since... 

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