Certification package requirements

Testing a minimum of five production lots of the material (automotive certification packages require testing 30 production lots for some properties) to produce data that is truly representative, the total cost can easily exceed 75,000 per material. 

Certification. Verify that product matches packaging requirements. Maintain packaging if o-ring has no stencilling. 

Note 1 Before the first shipment of any package requiring competent authority approval of the design, the consignor shall ensure that a copy of the approval certificate for that design has been submitted to the competent authority of each country (see para. 558 of the Regulations). 

Cover the classification, packaging and labelling of dangerous goods. The requirements for design, manufacture, modification, repair, approval, certification and marking of transportable pressure containers are included. The role of approved persons to comply with the regulations is explained. 

Beyond perfonnance optimization, issues relative to packaging and the need for compliance with certain safety and electronics regulatory codes are cited as reasons for a customized solution. In the latter case, a systems approach is required, especially when attempting to meet the code or performance requirements for compliance with European Certification (CE) mark or electrical and fire safety codes such as National Eire Prevention Association (NFPA) and CENELEC (European Committee for Electrotechiucal Standardization). Off-the-shelf electronics may provide the necessary performance characteristics for generic applications, and their use eliminates large expenses related to product development, plus the associated time delays. Photonics-related components are solely addressed in this section because they are used to customize instruments for application-specific systems. 

The requirements for special training or certifications/registrations for specific project tasks are also addressed in the QAPP. An important element of this group is A9, the description of the field and laboratory records and the resulting data packages and their contents. 

There exists a set of administrative requirements specifically for imported finished products. A prominent example is the requirement of a detailed Certificate of Free Sale from the authorities in the country of origin, to be provided at the time of submission of the application. Package layout, package inserts and labeling should conform to local directives. All manufacturing sites involved in the manufacturing process have to be approved specifically with respect to GMP. For imported products, a GMP certificate of the relevant authorities and a plant meister file have to be provided. 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

The system for incorporating special customer requirements into production operations, e.g. certificate, special packaging, labelling. 

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