Method transfer protocols

The process of method transfer must follow a method-transfer protocol which defines the experiments and acceptance criteria necessary to demonstrate the analysts proficiency, equipment s suitability, and true ruggedness of the analytical method. If we assume that any quality analytical laboratory has proficient analysts who operate suitable equipment, then the method transfer stands as an ongoing means to substantiate the suitability of the original method validation. Example 5 contains an example of a method-transfer protocol for a chromatographic procedure. 

Method-Transfer Protocol Determination of Substance J and Related Compounds in Tablets... 

Use of validated, stability-indicating methods Evaluation of forced degradation products Properly executed method transfer protocols Use of qualified and calibrated equipment by trained analyst Use of qualified and calibrated stability chambers or rooms Handling of OOS and OOT results Timely implementation of corrective actions Stability chambers/rooms... 

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. 

Difficulties in using HPLC methods frequently arise when a method is developed in one laboratory and is then transferred for use in another laboratory. To overcome this problem, there is a current trend towards developing method transfer protocols to facilitate a smoother transition. These protocols not only involve additional testing but also may even involve visits (for observation and supervised introduction to carrying out the method) of staff between sites. This seems over elaborate and it remains to be seen whether this trend will continue given that it should not be necessary if a method has been rigorously documented and validated. 

A qualified individual from the transferring laboratory typically writes the method transfer protocol. Management and QA representatives of both the transferring and the receiving laboratory must approve the transfer plan. As a guide, the transfer plan may contain the following ... 

Before the planning of any transfer, an approved document that describes both the general transfer process as well as the specific acceptance criteria necessary for the method(s) being transferred needs to be in place. In many companies, it is common for both the R D and quality units to have general standard operating procedures (SOPs) that govern the transfer process. These SOPs describe the details of a method transfer protocol that is specific to the product and methods. The contents of such a protocol were described in various chapters earlier in this text however, they are important and bear repeating here. 

The method transfer protocol is typically written by the originating lab with review and approval by both labs however, other approaches can be used. In some cases, the receiving lab has their own SOP that they need to follow especially in the... 

Individual protocols and reports can be written for each test to facilitate transfer of specific mefhods. This approach allows a discrepancy fo be investigated while not holding up unaffected method transfer activities. To facilitate internal and regulatory inspections, the method transfer protocols and reports should be compiled for easy review at the receiving site. The raw data should be readily accessible. Transfer of any relevant documentation such as methods, specifications, validation reports, reference standard information should be completed. From this point on, the change control process should assure that methods and specifications remain the same at the qualified fesfing sifes except perhaps for document format. 

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