21 Cfr 820 Quality Agreement
By containing detailed records, you can easily organize and maintain information about past partners or customers. As a proven method, you should avoid using paper records or documents, as they can easily be damaged or lost. A document control system supports the management of these files and ensures that they comply with documentation quality management rules and systems. It is important to remember that ASAs are often seen as a determinant of the overall health of a quality system. If CAPA procedures are not followed in accordance with the RQ, an inspector will quickly suspect other areas that could also suffer from similar poor quality practices. Develop, manage, control and monitor production processes to ensure that a device complies with its specifications. Also define and maintain procedures for modifying a specification, method, process, or procedure. Changes must be checked or validated. the control of environmental conditions likely to have a negative impact on the quality of products. Establish and maintain a process for staff health, cleanliness, personal practices and clothing requirements as well. procedures to avoid contamination of equipment or products by substances likely to have a negative effect on the quality of the product. Other processes must be established and maintained with respect to buildings, equipment, adaptation, manufacturing materials, automated processes, inspection, measurement and testing equipment, and process validation. It is necessary to avoid negative effects on the entire process and to guarantee quality.
Manufacturers should have good judgment in the development of their quality assurance system and apply the sections of the SAQ regulation that apply to their specific products and procedures. Section 820.5 of the QS Regulation states that “each manufacturer shall establish and maintain a quality system appropriate to the specific product(s) and meeting the requirements of this Part”.; The word “appropriate” means that it is generally flexible regulation. However, if manufacturers decide not to apply certain GMP requirements qualified by the term “where applicable”, they must document their reasons for non-transposition. The explanatory memorandum should indicate that the non-application of a requirement cannot reasonably lead to the absence of a product conforming to the specifications or to the absence of necessary corrective measures [820.1 (a) 30]. Within the framework of this flexibility, it is the responsibility of each manufacturer to set requirements for each type of device or family of products that lead to safe and effective products and to define methods and procedures for the development, manufacture and marketing of products that meet the requirements of the quality system. The FDA has identified, in the SAQ regulation, the essential elements that a quality system must embody for design, production and distribution, without imposing specific means to define these elements. Since the SAQ regulation covers a wide range of equipment and production processes, it leaves some leeway in the details of the elements of the quality system. It is up to manufacturers to determine the need or extent of certain quality elements and to develop and implement specific procedures tailored to their respective processes and devices.. .
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