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The Laboratory Managerial and Administrative Systems are those sub elements that provide the infrastructure for efficient and compliant operations of an analytical laboratory. It is sometimes difficult to directly relate items within this sub element to the Current Good Manufacturing Practices (CGMPs). However, deficiencies within this sub element, which cannot be directly attributed to the CGMPs, can lead to compliance failures. For example, 21 CFR Sections 210 and 211 do not specifically require that someone be assigned the duties of training manager. However, failing to have an individual responsible for training and consequently not having an effective training program can degrade the overall quality of data that is generated by laboratory personnel, and US Food and Drug Administration (US FDA) has cited companies for not having a training program for laboratory personnel [1].

The Laboratory Managerial and Administrative Systems sub element includes at least six individual topics. A laboratory that is in compliance with CGMPs should at least address each of these topics (as applicable). These topics include (i) Organizational Structure and Roles and Responsibilities, (ii) Training and Qualification, (iii) Laboratory Budgeting, Purchasing, and Requisition, (iv) Laboratory Administration and Operations, (v) Laboratory Chemicals, Solutions, Reagents and Supplies, and (vi) Laboratory Reference Standards and Solutions.

These six topics are listed within the text of the chapter along with some suggestions on what items should be addressed in each topic. The list of items under each topic is fairly comprehensive but may not be totally inclusive of all those components, which may constitute the sub element.