Availability of a Protocol Containing Predetermined Acceptance Criteria

5 Availability of a Protocol Containing Predetermined Acceptance Criteria 

The methods transfer protocol is the main driver that governs the conduct of the experiments and ensures that assessment of results generated is not unduly influenced by biases due to either (a) the analytical method or (b) inherent batch-to-batch variability of the active pharmaceutical ingredient or pharmaceutical dosage form. The methods transfer protocol establishes the predetermined acceptance criteria by which results will be judged to have either passed or failed the methods transfer. The criteria for assessment of success or failure contained in the methods transfer protocol is achieved through an iterative 

Since the aim of the protocol is to ensure the mitigation of problems, the essential elements of the protocol consists of sections that include (a) an Introduction, (b) treatment and disposition of data, (c) types of methods being transferred, (d) materials, reference standards, and reagents being used, (e) recommended type of equipment, (f) sample handling, (g) predetermined acceptance criteria, and (h) an Acknowledgment section. An example of a typical table of contents (TOC) of an analytical methods transfer protocol is discussed in Table 16-2. 

TABLE 16-2. Table of Contents of an Example of Analytical Transfer Protocol 

Introduction Aim and scope of the protocol Brief description of dosage forms Arguments for waivers, bracketing, and matrixing (if applicable) 

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