Type certificate

A WHO-type certificate of a pharmaceutical product (CPP) issued by one of the regulatory authorities of ICH regions YES NO... 

Justification for any differences of the product in the country or countries issuing the submitted WHO-type certificate(s)... 

Those required for type certification or by operating rules, or whose improper functioning would reduce safety, perform as intended under the aeroplane operating and environmental conditions. 

Fig. 11.1 provides a simple illustration of the role the Design Organisation plays in through life safety of their type-certificated products. The following subsections will explore some of these interfaces and how the flow of hazard information finds its way into the ICA. 

A CMR is a required periodic task established during the design certification of the aeroplane as an operating limitation of the type certification. 

Minimum Equipment required for dispatch of the aircraft. The regulatory authorities require that aU equipment installed on an aeroplane in compliance with the Type Certification Basis must be operative. Experience has proven that, due to the various levels of redundancy designed into an aeroplane, operation of every system or installed component may not be necessary when the remaining operative equipment satisfies the airworthiness authorities (ARPS 150, para 3.4.2). Therefore, certain conditional deviations from the original requirement are authorised to permit aeroplane dispatch. These Dispatch Deviations identity ... 

Strictly speaking, this is applicable to each DO who is a holder of a type certificate, restricted type certificate, supplemental type certificate, European Technical Standard Order (ETSO) authorisation or major repair design approval [EASA 21.A.3.A]. 

Continued Airworthiness Means aU tasks to be carried out to verify that the conditions under which a type certificate or a supplemental type certificate has been granted continue to be fulfilled at any time during its period of validity [EMAR 21]. For example tasks, see EASA Part 21 21.A.3, 21.A.57, 21.A.119, 21.A.120, 21.A.61, and 21.A.265. 

Master Minimum Equipment List A list of equipment and functions which need not be operative for safe flight and landing based on stated compensating precautions created during aeroplane type certification [ARPS 150]. 

Type Certification Basis All the Airworthiness Standards/Design Codes (e.g. 14 CFR Part 25 or CS-25) and the Operating Rules (e.g. 14 CFR Parts 91,121 or CS-26) which the aircraft has been designed to comply with. 

The requirements for European Community (EC)-type certification are declaration of conformity and technical documentation files for all categories of gloves. For categories II and III, there are additional requirements EC-type examination testing by approved laboratories, certified by approved notified bodies and manufacturing under a formal EC quality assurance system. 

The process is typically concluded with the Authority issuing a Type Certificate... 

Terminated upon issuing, by the authority, of the Type Certificate (or, in the case of modification, a Supplemental Type Certificate) for that specific aircraft or airborne system. Reactivated on performing a major modification/repair, or if non-compliance to the conditions in the TC/STC are suspected. 

Candidate certification maintenance requirements (CCMR) Aperiodic maintenance or flight crew check may be used in a safety analysis to help demonstrate compliance with JAR 25.1309(b) for hazardous and catastrophic failure conditions. Where such checks cannot be accepted as basic servicing or airmanship they become candidate certification maintenance requirements (CCMRs) (AMC to CS25.1309). (Note AMC 25.19 defines a method by which certification maintenance requirements (CMRs) are identified from the candidates. A CMR becomes a required periodic maintenance check identified as an operating limitation of the type certificate for the aeroplane.)... 

Type certificate The type certificate is considered to include the type design, the operating limitations, the type certificate data sheet, the applicable requirements with which the authority records compliance, and any other conditions or limitations prescribed for the product in the appropriate regulatory code (JAR21.4). 

The Agency s certification work also includes all post-certification activities, such as the approval of changes to, and repairs of, aeronautical products and their components, as well as the issuing of airworthiness directives to correct any potentially unsafe situation. All type-certificates are therefore now issued by the European Aviation Safety Agency and are valid throughout the European Union. 

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