SOP.See standard operating procedure

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

Standard Operating Procedure (SOP, see ISO 78-2 [1999]). Complete Analytical Procedure, according to Kaiser [1965]... 

Method development includes feasibility and optimization to meet the predefined study requirements. The appropriate standard calibrator range and concentrations of VS and QC (see discussion below) should be established for the dosage form and route of administration. The lessons learned during method development are critical for the development of specific parameters for the performance of the assay. For example, the number of validation batches and acceptance criteria should be described in a validation plan, and the standard operating procedure (SOP) should be written before conducting the pre-study validation. The correct approach should be to develop a valid (acceptable) method, rather than simply... 

The term standard operating procedure (SOP) is properly restricted to CLP operations (see Section 5.2 and below) where it has a precise definition within the terms of the standard. However, the term is widely used by laboratories not complying with GLP as a synonym for procedures to emphasise the importance of following them as standard practice (see Section 2.2). 

The procurement agency should have written, clear and detailed standard operating procedures (SOPs) for all the activities to be performed in the procurement agency. The content of each SOP, particularly the step-by-step descriptions of activities and approved recording or reporting formats attached as addenda (see below), should reflect the operations of the particular procurement agency. 

Because of their great importance to TLC, the various types of reference substances are described in the following Section. These are often known as standards and must only be used if they are of suitable quahty for the intended application. These levels of quality are of especial importance in the field of pharmacy. All the relevant requirements must therefore be controlled in an SOP (standard operating procedure, see Chapter 9 GMP/GLP-Conforming Operations in TLC ). 

Clinical trial supplies which include full QC and supporting stability studies to show that product-pack is satisfactory for issue (i.e. IND stage in the USA). See also (8) below, paying usual attention to GMP, effectiveness of standard operation procedures (SOPs), etc. 

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