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009, Sections 1 8 of the interpretation of regulation C02010, Sections 1 and 2 of regulation C02016, Section 4 of its interpretation, and Section 1 of the interpretation of regulation C02017 Interpretations 6 and 7 of regulation C02009 and interpretations 1 8 of regulation C02010 cover the requirements for components Sections 1 and 2 and interpretation 4 of regulation C02016 and interpretation 1 of regulation C02017 state the requirements for drug product containers and closures In the Canadian GMP code there is no correspondence to regulation 21186, which covers the requirements for the rotation of the storage Correspondences to regulation 21187 stating the requirements for the retesting of approved components are covered in Sections 8 10 of the interpretation of regulation C02009.

For the retesting of drug product containers and closures the Canadian GMP code has no guidance Correspondences to regulation 21189 stating the requirements for the handling of rejected components and drug product containers and closures are covered in Section 14 of the interpretation of regulation C02011 and in Section 5 of the interpretation of regulation C02014 The Canadian GMP code does not have correspondence to regulation 21194, which covers the requirements for containers and closure systems Correspondences in EU GMP Code In the EU GMP code [15] issues related to control of components and drug product containers and closures are mainly covered in 5 (Production) and partly in 6 (Quality Control) Correspondences to regulation 21180 are covered in Subchapters 52, 57, 510, 529, and 540 542, which cover the requirements for the handling, storing, and identi cation.

8.055 1.848

and APT returns a list of all the packages that have new versions available. You are then given the option to upgrade those packages. APT can even be used to upgrade your entire system if a new version of your system becomes available. You can do that by giving the command

core through various digital networks or storage media (e.g., a CD). The image data are de-identi ed before they are sent out. 2. The images received by the radiology core go through a QC (quality control) WS (workstation) to assure image quality, for example, regarding patient positioning, equipment calibration, space localization, acquisition parameters, and patient demographic information. Once the quality of the images is approved, the images are sent to a centralized image server. 3. The image server extracts the metadata from the DICOM header of the image and stores the metadata and related patient information in the database of a data repository, such as RAID (redundant array of independent disks). The images are distributed to assigned radiologists of eld sites worldwide to make diagnosis. The diagnosis results, usually quantity numbers, are returned and stored in the metadata database. 4. The images stored in the repository are also backed up in an off-line manual storage device. This work ow and setup at the radiology core can satisfy a small number of clinical trials. With the ever-increasing number of clinical trials, it becomes a great challenge for a radiology core that handles multiple clinical trials to have a robust server to administrate multiple trials as well as satisfy the requirements to quickly distribute information to participating radiologists/clinicians worldwide to assess trials results. In addition different clinical trials can vary in the parameters of results. A dynamic database model is necessary for the image server in the radiology core to accommodate new clinical trials. All these issues underline the need for a new infrastructure that can satisfy the requirements of imaging-based clinical trials. Data Grid, an emerging image storage and distribution computing technology, is an ideal solution to this new demand. 21.5.3 Data Grid for Clinical Trials Image Storage and Backup

Internal politics or other bureaucratic issues that an internal group is often faced with, or the potential budgetary constraints that often hamper progress or restrain exibility, do not restrict the outsourcer. The supplier of outsourced services is there to support the client and to assist the client in meeting its goals and objectives. There is usually much greater con ict between internal resources than there is between a client and a supplier whose long-term relationship and payment depends on the customer s satisfaction.