Waiver of Transfer

In spite of such arguments, it must be noted that even when a waiver transfer is judged to be justified and acceptable, it may still be prudent to expect a minimum interlaboratory cross-over testing to provide continued assurance that the receiving lab can reliably and competently perform the tests. 

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Technology transfer can be demonstrated by several different options including comparative testing, co-validation of methods between laboratories, complete (or partial) re-validation by the receiving unit and a waiver of transfer procedures. 

Agut et al. (2011) assessed the different technology transfer options and reported that within Sanofi-Aventis that option 1 (comparative testing) is the approach of choice for critical methodologies, i.e. assay, degradation products, and in some cases water content and dissolution. Option 2 (co-validation) is reserved for less-critical methodologies, i.e. residual solvents by gas chromatography (GC), water content, dissolution and particle size methods whereas, option 4 (transfer waiver) is restricted to pharmacopoeial compendial methods, i.e. appearance, pH, particulate matter, etc. 

Raska et al. (2010) introduced the concept of a risk based method transfer process (which is similar to USP transfer waiver approach). This involves assessing the risk that the sites involved in method transfer could generate non-comparable data either at transfer or subsequently thereafter and assessing the probability of that risk occurring. Thus with constrained resource it is more sensible to focus that resource on either avoidance or mitigation of high risk transfers, whilst accepting the limited risk inherent with a low probability risk scenario. 

On the basis of this risk assessment the transfer strategy is evaluated. For those transfers with lowest risk, method transfer will be limited to simple knowledge transfer as there is no added value in performing any practical transfer exercises i.e. transfer waiver. 

This is a similar approach to that articulated by USP, where transfer waivers can be utilised if the receiving site is considered to be qualified to use the method(s), without comparison or generation of inter-laboratory comparative data. The different types of testing associated with the different types of method transfer, together with acceptance criteria are summarised in Table 5 (Raska et al., 2010). 

Method transfer is loosely defined as a process that qualifies a laboratory to use a test procedure or analytical method. According to this definition, any and all means of having a laboratory qualified would meet the criteria for transfer. The most common variations of method transfer are comparative testing, covalidation between two laboratories or sites, complete or partial method validation or revalidation, and the omission of formal transfer processes, sometimes termed the transfer waiver. ... 

A list of all methods to be transferred via comparative testing. Rationale for any methods not included, i.e., transfer waiver, must also be provided. 

Simple means tests with no independent verification of income are not uncommon. Sometimes verification is completely nonexistent in that a program intake worker simply records what an applicant says. Sometimes a social worker will visit the household to verify in a qualitative way that visible standards of living (which reflect income or wealth) are more or less consistent with the figures reported. Alternatively, the social worker s assessment may be wholly qualitative, taking into account many factors about the household s needs and means, but not having to quantify them. These types of simple means tests are used for both direct transfer programs and for fee waiver programs, with or without household visits. 

Political support for fee waivers cannot be assessed in isolation from the existence of user fees. On the one hand, fees for health care are highly controversial (see Hutton 2004 for a description of the establishment of fees and the need for exemptions), and waiver systems are often not thought to be the solution in relation to health care. On the other hand, fee waivers and scholarships for students are popular, especially among international development agencies, because health and schooling provide the link between short-mn transfer benefits and long-run human capital formation. Therefore countries want to use the fees to improve the quality of the services while finding ways not to exclude the poor. 

In some cases the method transfer can be waived. Such cases include the transfer of a compendial method, a transfer in which the method to be transferred is similar to one already in use by the receiving laboratory, or one where the scientist that developed, validated, and/or runs the method on a regular basis transfers to the receiving lab. If the method is to be used with a new product and the new product is similar in composition to an existing product, then a waiver may also be applied. 

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