Documentation need for

As stated in Part 2 Chapter 1, maintenance is concerned with retaining something in or restoring something to a state in which it can perform its required function. Quality systems comprise the organization, resources, and processes as well as the documentation needed for achieving quality, so you need to maintain more than the documentation. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

The topics being addressed in the context of registration of drugs for human use come from the three main themes safety (S), efficacy, (E), and quality (Q). Other topics have been subsumed under multidisciplinary (M). The main focus of ICH is on the studies and documentation needed for submissions for marketing approval to the health authorities. 

Well-prepared draft labeling can go a long way toward hastening NDA approval. The FDA, if satisfied with the draft labeling, sometimes will bypass the approvable letter if the labeling is the only document needed for final NDA approval. This will be done only if editorial or minor modifications, not substantive changes, need to be made in the labeling. 

Each spedrication sheet should contain the required documentation needs, for instance ... 

All CTs (phase IV ones included) need ethical approval by independent central or regional ethics committees, as specified by a Decree of the Minister of Health in 1987, to be issued in an amended form in 1999. Phase I-III trials also need authorization by the competent medicine regulatory authority (the NIP or the Executive Office of the National Chief Medical Officer). The documentation needed for authorization does not differ from that in the EU. In short, it consists of the following (if not specified, it may be in English German may also be accepted) ... 

This section, or sections, of the protocol describes the responsibilities of the pharmaceutical or biotechnology company and the departments within the company in carrying out a validation as well as listing the documentation needed for reference including SOP 123.]... 

HIPAA requirements for subject privacy is increasing the amount of documentation needed for the initiation of a trial. Besides the requirement for informed consent, which has evolved from the Declaration of Helsinki, there is now an additional need for authorization from the subject for release of the individually identifiable health information that the drug sponsor must enter into the data bank for statistical analysis to comply with requirements necessary for new product approvals. However, HIPAA does not include data needed for adverse experience reporting assessments for clinical trials. 

Chapter 5 introduces the stability studies needed to support post-approval changes. This chapter also covers change control requirements as well as documentation needed for these changes. 

The documentation needed for a hazards analysis will vary according to the scope of the work. However, the following are usually required, depending on the level of detail that is required ... 

Commission the plant and finalize all technical documentation needed for operation and maintenance. 

Depending on the needs of an organization, the rights to use some already-established data sets can be acquired. Other data can be collected by the user and stored in appropriate data files. This includes records already accumulated by an individual or organization. Gonverting and storing records in GIS format is particularly useful for creating the documents needed for a time-series analysis of particular... 

With reference to Section 6.2.2.3, we now compare the structure of the dossier needed for approval of medicines and MDs. Of course, a direct comparison is not possible and the correlations estabhshed can therefore be challenged. We intend oidy to highlight some differences and similarities between the documents needed for medicines and MDs. 

Table 6J1 Differences and similarities between the documents needed for medicines and medical devices...

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