Transfer

Transfer
Research & Development

Transfer

TRANSFER OF ANALYTICAL METHODS

Testing the medicinal products prior their release to the market, throughout their life-cycle, during their routine manufacturing, but also during their development is fundamental for pharmaceutical industry. The analysis of e.g., starting materials, reagents, intermediates, active substances and finished dosage forms plays a significant role in achieving and confirming the quality, efficiency and safety of medicinal products. Each product undergoes analytical control based on analytical methods demonstrated to be suitable for the intended purpose. This is why analytical methods are an inherent part of pharmaceutical industry. The European Pharmacopeia (Ph.Eur.) provides a scientific basis for quality control and contains general methods of analysis. However, in some cases e.g. where no monograph for a particular medicinal product is provided, it is necessary to develop an in-house method. The analytical procedures given in the monographs are considered to be validated, but in-house developed procedures require validation. The appropriate analytical method might be developed, validated and used in several different laboratory sites, but moving it between sites should be done via means of an analytical method transfer. It should also be kept in mind that each pharmacopoeial method must be properly implemented, therefore, when transferring analytical methods from one laboratory to another, also pharmacopoeial methods are often subject to method transfer (this is assessed in detail during the risk analysis included in the protocol).

TRANSFER AND ITS MODES

The general idea of method transfer is covered by Annex 7, WHO (1] and GMP Chapter 6 (2)
Some helpful details can be found also in United States Pharmacopeia (USP) (3] Essentially, the aim is to bring a given method from one laboratory to another, without harm to
its performance.

USP defines transfer of analytical methods as a documented process that qualifies a laboratory (the receiving unit, RU) to use an analytical test method that originated in another laboratory (the transferring or sending unit, SU), thus ensuring that the RU has the procedural knowledge and ability to perform the transferred analytical procedure as intended. The following four types of transfers are recognized: comparative testing, covalidation, revalidation and transfer waiver.


COMPARATIVE TESTING


The most common variant of method transfer. It requires analysis of predetermined number of samples of the same lot by both the SU and the RU followed by a comparison of the results. The testing is based on a previously approved transfer protocol in which the acceptance criteria and the acceptable variability are pre-defined. The method of interest should be validated in the SU prior to its transfer. A transfer report should be prepared with confirmation that the pre-defined acceptance criteria were met.

REVALIDATION

If the method was validated, but significant adiustments were made in the RU (e.g. to equipment/reagent or to conditions of analysis), the RU is required to perform a complete or partial method validation. This should ensure that the method is still suitable for its intended purpose. Revalidation strategy is also often chosen when other types of transfer are inviable or not available for any other reason (e.g. the SU at which the method was initially validated is unable to take part in the transfer). According to the ICH 02, the extent of revalidation depends on the analytical performance characteristics impacted by the applied change(s) (4]. Revalidation approach requires preparation of respective protocol (including justification of the scope of revalidation necessary) and report.


TRANSFER WAIVER

There are certain circumstances that allow to omit the formal method transfer, which include:

  • The RU is already familiar with the product (or is experienced with the similar one) and the testing procedure
  • The concerned analytical method is pharmacopeial
  • Transferred method (or a very similar one) is already in use in the RU
  • The SU personnel in charge of the development, validation or routine analysis are moved to the RU

JUSTIFICATION OF CHOICE

The choice of type of transfer should be based on appropriate risk analysis that takes into account several factors, such as validation status, complexity of the method and the previous experience and knowledge of the RU. Justification of the decision should be presented in the above-mentioned transfer protocol. which is an essential document stipulating all the details of the transfer procedure. A well-designed protocol is a key factor in a successful method transfer
- it should be thoroughly discussed, agreed on and documented before the start of the transfer.