Declaration of compliance

Commission Directive 2005/31/EC of 29 April 2005 amending Conncil Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method for ceramic articles intended to come into contact with foodstnffs. OJ L no, 30.4.2005, p. 36. 

In the absence of specific measures, this Regulation shall not prevent Member States from retaining or adopting national provisions for declarations of compliance for materials and articles. 

If required in a specific measure, then relevant food contact materials (FCM) shall be accompanied with a declaration of compliance, while appropriate documents shall be provided to relevant authorities to demonstrate such compliance. As most of the requirements in the framework regulation are applicable to all FCM, active and intelligent materials are subject to these rules as they can be considered FCM. In some cases there may be no direct contact with the food, e.g., intelligent packaging positioned on the outside of the primary package, but they are subject to the framework regulation for the reliability of the information provided to the consumer. 

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. 

Compliance with the ICH Good Clinical Practice Guidelines (incorporates the Declaration of Helsinki) or equivalent should be required. 

Action Levels. The scheme requires that the exposures of one or more potentially-exposed workers be monitored periodically. If all of the air concentrations measured are below the "action level (AL), which is of the "permissible exposure limit" (PEL), then no further action is required unless the process is changed. The workplace is deemed to be in compliance with the standard. If a value exceeds the PEL, the workplace is declared to be out of compliance and some form of remedial action is required, e.g., a process change, engineering controls or personal protective equipment. Finally, if the sample value is between the AL and the PEL further sampling is required until two values in a row are observed below the AL (workplace in compliance) or one value is observed above the PEL (workplace out of compliance). 

Probabilities that Various Hazardous Distributions of Exposures to HCN Would Be Declared In Compliance by the OSHA/NIOSH Scheme and Expected Fatal Excursions (cjg = 3.5)... 

The second section contains four template quality manuals written in compliance with international standard ISO 9001 2000 to provide the statement of company approach and declaration of interest as to how the requirements of the ISO 9001 2001 quality management standard are to be addressed. This section is comprised of four sample quality manuals presented as Model-1, Model-2, Model-3, and Model-4, respectively. 

Each of the viewpoints is a declarative statement of intent to be achieved by the system (i.e., the software-to-be together with its environment) under consideration. It is represented by models of the system and its process of development. The representation forms a justified strategy or means of compliance. 

Compliance with the requirements of Directive 2001/20/EC is important. This is because Annex I to Directive 2001/83/EC (as amended) expressly requires that for the purpose of obtaining a marketing authorization, all clinical trials conducted within the European Union to comply with Directive 2001/20/EC. For clinical trials conducted outside the European Union and the data of which are used in support of an application for a marketing authorization, such clinical trials must be designed, implemented, and reported on the basis of principles that are equivalent to the provisions of Directive 2001/20/ EC and carried out in accordance with the ethical principles that are reflected in the Declaration of Helsinki. 

For each clinical study, there should be statements that the study was conducted in compliance with the informed consent regulations and either the IRB regulations or the Declaration of Helsinki. If any obligations for the conduct of the study were transferred to a CRO, the name and address of the CRO and the obligations transferred should be listed in the NDA. The clinical sites audited or monitored by the sponsor should be identified, either as part of the report for the study or as a separate list. 

All consent documents and the entire informed consent process should be designed and implemented to be in compliance with the above-stated regulations, as well as consistent with the principles of the Declaration of Helsinki, World Medical Assembly, Revised 1996, 48th General Assembly, the accepted... 

In most industrial countries and those at the threshold of industrialization, the field of explosion protection for electrical apparatus and systems is subject to legislation. The usual procedure, that a manufacturer declares the conformity of a product with a given standard under his own responsibility, is altered in such a way that an administrative body nominated by the government of a state, or, in states with a federal structure, nominated by the authority of a land, issues an approval which declares the compliance with a standard and with legislative acts in parallel. On this basis, the apparatus may be commissioned and put into service. 

Additionally the French authorities have implemented specific regulations in order to prevent non-declared taxable activities. According to French law any person or entity that executes a services agreement providing for financial compensation of 3000 or more per year must verify that the service provider (e.g. doctor or pharmacist) complies with tax and social security obligations. The beneficiary of this service (e.g. the pharmaceutical company) must request evidence of compliance with these regulations every six months for the duration of the contract. The documentation required is listed in Article R.324-4 of the French Labor Code. If a beneficiary of a service (e.g. the pharmaceutical company) fails to do this they may themselves be liable for the payment of these taxes/ ... 

The manufacturing department ships the product in accordance with manufacturing guidelines, based on the receipt of valid purchase orders. The product documentation includes a Declaration of System Validation with statements from Hewlett-Packard that the software was developed and tested according to the Hewlett-Packard Analytical Software Life Cycle, a process that has been certified for ISO 9001 quality standard and for the information technology quality system (ITQS) compliance and that has been inspected by representatives from both computer validation companies and the pharmaceutical industry. 

GCP is an international ethical and scientific quality standard for the designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with the 13 core principles of this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected, consistent with principles have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 

An effective QM system for clinical research helps assure that studies are planned, conducted, analyzed, reported and managed in compliance with GCP guidelines and ethical principles as noted in the Declaration of Helsinki, so that dependable trial results are achieved while ensuring that trial participants are protected. 

If a generic subject information sheet and informed consent form are attached to the protocol, these documents should also be reviewed for compliance with any requirements for informed consent, such as GCP, SOPs and the Declaration of Helsinki, and for consistency with the trial protocol. The information sheet and informed consent forms must be written in a language understandable to the trial participant and should include information on data protection/privacy. Further information on protocol and informed consent audits is available in literature (Bohaychuk and Ball, 1999 DGGF, 2003). 

The treatment of declarations in the Compliance Protocol reflects these diverging interests both with respect to initial declarations as well as annual declarations that states parties would have to submit.47 According to Article 4 of the Protocol, initial declarations of a number of facilities and activities have to be submitted within 180 days after entry into force of the Protocol annual declarations not later than the end of April for each year. 

Thus, the new legislation defined strict good manufacturing practices, which provided detailed rules governing the controls that must be in place in the facility, the equipment, the people, the documentation, and the process. It essentially said that if a factory was found to be out of compliance to the GMP requirements, it could not assure that any batch of product was free of contamination hence, all batches are declared contaminated, regardless of the testing results for any batch. 

The CWC provides for routine and challenge inspections to assist in the verification of compliance w ith the Convention. Routine inspections of declared facilities are mandated by the Convention. In accordance w ith CWC provisions, challenge inspections may be conducted at a facility w here a Party suspects illegal activities. The CWC does not include a specific list of controlled chemicals or equipment. It does contain an Annex on Chemicals in which are listed three Schedules of toxic... 

For most products and machines, the self-declaration process (module A) is possible. In practice the manufacturer performs the complete product assessment according to EU standards, issues the declaration, and affixes the CE marking to the product. A technical file or documentation must also be available on demand for national enforcement authorities. Keep in mind that this is an internal self-assessment process, a do-it-yourself approach, that results in issuance of the manufacturer s declaration of conformity and the CE marking (Figure 2-6). The buyer may demand proof of safety/EMC compliance in the form of a mark, certificate, or test report from a European notified or competent body. 

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