Certification protocol

Despite the differences in the structure in organic certification between EU countries, the basic protocol remains the same regardless of which certification body is involved. This protocol (Table 3.2) involves the following steps  

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To satisfactorily meet and address these regulatory and market needs, standard methods for emissions testing need to be both robust and repeatable for competent laboratories to carry out, and practical and affordable for manufacturing industry. Uniformity of test methods, between countries and markets is also important if manufacturers are to avoid having to submit the same products for emissions testing by multiple different emissions certification protocols. 

Regulations, Standard Methods and Test/Certification Protocols 131... 

Before reviewing the range of standard methods and protocols that are already published or that are in the later stages of development, it is important to understand the fundamental differences and relationship between legislation or regulations, analytical test methods and certification protocols and product standards ... 

Test or Certification Protocols and/or Product Standards are similar to standard test methods but include additional criteria (requirements). Typical test protocols or product standards specify which emission test method should be used, when it should be carried out (for example 3 days, 12 days or 28 days after the sample has been placed in the test apparatus), a list of target compounds (i.e., which compounds or groups of compounds are to be measured) and pass/fail criteria (i.e., limit levels for emissions above which a product would fail the certification process because one or more compounds are being emitted from that product material at an unacceptably high rate.)... 

Clinical laboratories can promote standardization by encouraging their kit suppliers to participate in the CRMLN comparison process. In addition, individual laboratories can also make arrangements with a CRMLN laboratory to participate in an abbreviated certification protocol for total cholesterol and complete comparison studies for the other analytes, especially useful in the case of new or modified systems. The CRMLN program is supported by modest user fees. 

Finally, it should be mentioned that the number of new materials and devices described in the literature, which results in commercially available products, is limited. Several innovative sorbents and adsorbents have not progressed beyond the stage of academic research, despite their potential application to relevant analytical problems. The reasons for this range from the lack of experience (and even interest) of some research groups to enter partnerships with analytical instrumentation industries, to the perception that the excessive rigor required in the application of analytical validation and certification protocols may sometimes delay or even hinder the acceptance of new analytical techniques. °°... 

Snhseqnent chapters cover installation considerations (Chapter 6), inspection and maintenance practices (Chapter 7), regnlations, standards, and codes, inclnding certification test protocols (Chapter 8), and some illnstrative examples (Chapter 9). Chapter 10 provides a snmmary of the present state-of-the-art and what other information and research is needed, followed hy appendixes, a glossary, and snggested additional reading. 

Certificate of agreement between sponsor and investigator when not in the protocol... 

After the performance of collaborative studies organized by the RIVM (National Institute of Ihiblic Health and Environmental Protection, Bilthoven, The Netherlands) and SM T certification studies were performed by a group of eleven or twelve qualified European laboratories. These examined simultaneously the materials using standardized methods following a very strict analytical protocol. Table 5.1 below shows data for CRM 506 (Mooijman et al. 1999)-... 

The Study Director/Principal Investigator should ideally discuss all multi-site studies with QA personnel prior to study initiation (or prior to the issue of the protocol amendment if work is not detailed in the protocol). When acting as Study Director, a copy of the current GLP certificates should be requested from sub-contracted facilities and should be retained in QA. 

Validations fall into two types prospective and retrospective. In prospective validation (see flow chart in Figure 2) the validation is done in a sequential manner, involving installation qualification and operational qualification (IQ/OQ) of equipment (e.g., chromatography instrumentation or column hardware). Appropriate calibrations accompany the IQ/OQ. Process qualification, or PQ, involves formal review and approval of a PQ protocol, execution of this protocol, and issuance of a formal PQ report which includes data analysis and recommendations (i.e., approval/certification of the process). If the process is not approved, the report may recommend a redesign or redoing of the validation protocol and, in some cases, a return of the process to process development for further optimization. 

Finally, a certificate page should be included, verifying that the entire IQ protocol was completed successfully for a particular instrument. This should include the instrument s serial number, protocol approval sign-offs and any remarks. 

Located additional documents and manufacturer s certificates and placed them In the proper locatlon(s), as specified In this protocol ... 

A qualification verification certificate should be referenced, verifying that all individuals performing the OQ protocol are qualified to perform this protocol. This may be included as part of an overall IQ/OQ protocol. 

A validation test certificate, at least according to the system-suitability protocol, should be supplied when an instrument is sold. 

Facility personnel who perform testing and maintenance on fire protection equipment and systems must be trained, experienced, and knowledgeable in the systems and the protocols for testing and maintenance. Knowledge can include work history, educational experience, craft certification, manufacturer certification, field verification, and job assessment and testing. Facility person-... 

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