Document approval

These may change after tests and trials and therefore need to be brought under change control following the document approval. 

Dated, documented approval / favourable opinion of Institutional Review Board / Independent Ethics Committee of amendments... 

Sec. 820.40 Document controls - Establish procedures for document approval, revision and distribution... 

Prior to execution, the site preparation and document approval must take place. The equipment manufacturer will provide detailed site preparation requirements for the system. It is the responsibility of the customer to prepare the site as per the documented requirements. The operator will verify the site preparation during the testing of the... 

Appropriate and valid SOP s are established and follovired A Quality Assurance Program is in place A Study Director and a Principal Investigator, If needed, Is designated Documented approval of the study plan The study plan Is available to quality assurance personnel... 

In this shde the requirements of ISO/IEC 17025 for the document approval and issue ate shown. The next slides will show details following from these requirements. 

Responsibilities. This section captures the responsibilities of the approving departments prior to document approval. This way there will be no confusion when a responsibility arises during or after the document execution. 

The result of the OQ is a documented approval that the technical system fulfills the user requirements and all GMP-related functions of the technical system. 

A] document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory [emphasis added]. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. 

The facility should ensure the documented approval of the study plan by the study director. 

The investigator must conduct the clinical research study in accordance with the protocol agreed on by the sponsor. The investigator should not implement any deviation from, or changes in, the protocol without agreement by the sponsor and prior review and documented approval from the IRB. An investigator who has repeatedly or deliberately failed to comply with FDA requirements and has... 

Just like reviewers, document approvers should be identified in advance within the Validation Plan, the Project and Quality Plan, or the document management procedures. Again, many firms guide staff on the most appropriate choices of personnel for the sensitive and important task of document approval. 

Lack of change control documentation approving change in software. [FDA Warning Letter, 2001]... 

The XXXX form that documents approval to migrate the program to the production environment was not signed off by Quality Control. [FDA 483, 2002]... 

Validation organization Roles and responsibilities Validation documentation requirements Document approval authorities Key phasing and milestones... 

Document approval and release, including use of electronic signatures... 

National Committee for Clinical Laboratory Standards. Terminology and Definitions for Use in NCCLS Documents Approved Standard. NCCLS Document NRSCL08-A. Wayne, PA National Committee for Chnical Laboratory Standards, 1998. 

In Australia, the most commonly utilized and accessible information sources about prescription drugs are based on a drug s Product Information, the document approved by Australia s drug regulation authority, the Therapeutic Goods Administration (TGA). 

A Basic Packaging Document, approved and dated by the persons responsible for production and quality assurance, must exist for each end product. This condition can also be met by storing the data in other documents such as manuals or in a computer memory. 

The quality system must be described in written documents approved by management (policies, quality manual, etc). 

A document control system, including standard practices for numbering documents, their filing, the system of document approval and authorization of issue, distribution control, revision control, and archiving. 

Operation of a waste management facility shall comply with the operating conditions defined in the operating licence or other documentation approved by e regulator. For disposal facilities, the waste acceptance requirements constitute an important set of operating conditions. The waste acceptance requir ents for a repository should be derived fiom its design basis and from the results of the performance assessmoit. They may address e.g. the physical and chemical characteristics of... 

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