Analytical Methods

The use of an analytical method is to provide the user with concise and accurate instructions to qualitatively or quantitatively pursue a physical or chemical analysis of a component or components in a raw material, bulk or finished product. Analytical methods are chosen based on many variables. Choices depends on the concentration or level of active present in the formulation, interferences from the surrounding formulation matrix, type of instrumentation to be used, cost, time, safety, environmental conditions, etc. The use of an analytical method to test for a fluoride assay may not work the same for the fluoride ion at high and low concentrations. If analytical methods are designed for in-house use, lengthy and well-documented validation studies have to be conducted by the R&D group to ensure consistency in the recovery of the results. Most analytical testing laboratories use official methods published by many international organizations and government agencies. The test methods initiated by these organizations have been put through strict, thorough, controlled and robust testing to ensure workability before being published. Some of these organizations include:

(a) USP – United States Pharmacopoeia
(b) AOAC – Association of Official Analytical Chemists 
(e) CTFA – Cosmetics, Toiletries and Fragrances Association
(d) ASTM – American Society for Testing and Materials

Another ideal source of using validated analytical methods is from the customer or material supplier if your company is a contract manufacturer. However, to utilize these methods, a method transfer validation process must be implemented. To validate a transfer of a method from one laboratory to another is to have the two laboratories perform parallel testing on the same material. The laboratory being qualified will send their results, calculations, raw data, analytical charts, etc back to the experienced laboratory for review and evaluation. The laboratory performing the transfer of the method will review the results for precision and accuracy and determine if the results fall within the statistical acceptance criteria. If it does, the laboratory becomes qualified to use the transferred analytical method to perform the test.
In many cases, there is a temptation to deviate from a standard or official method. Any changes to be made must follow a change request procedure. The change request must be reviewed by the laboratory management to determine the reason for the change and the impact if any, on the analytical method.
Most times, the change request has to be forwarded to the originator of the method.
A re-validation of the method would have to be done to test the suitability and effectiveness of the change. If successful, the change request is approved and either the original method is recalled for revision and re-issue or a deviation is issued to make the change to the original method. In either case, the change request approval should be carefully filed in the event of an internal, customer or regulatory audit.

Standards are integral to ensuring safe and fair trade, as well as providing certain economic advantages. “Standards are gaining a higher profile in trade, and a large volume of unglamorous but essential work in the WTO deals with this,” says Bernard Kuiten, Head of External Relations, World Trade Organization (WTO) who will be moderating the event. “Governments want to ensure traded products are safe or simply convenient for their consumers and producers to use. But standards can be also an excuse to be protectionist. They should therefore be crafted in a way that boosts trade by raising market confidence in the goods and services traded.”

A great deal of collaboration is necessary between the international organizations involved in setting standards. This enhances harmonization and avoids duplication of work, increasing efficiency and simplifying matters for the end user. The Symposium with high-level speakers from ISO, Codex Alimentarius and the dairy industry will further demonstrate this spirit of collaboration, providing an opportunity for speakers and participants to hear expert views and share experiences on the development and use of international standards.

IDF and ISO have a long history of collaboration through a joint programme of work on methods of analysis and sampling for milk and milk products. In June 2012, AOAC INTERNATIONAL and ISO signed a collaboration agreement regarding methods for infant formula and adult nutritionals with involvement of IDF, leading to a presentation on harmonization during the Symposium.

Representing the global dairy sector, ensuring that standards best address the needs of the dairy sector for the fair trade of safe, high quality milk and milk products is an important aspect of IDF’s analytical programme of work. Collaboration is again at the heart of this activity, as Dr. Jaap Evers, Chair of the IDF Methods Standards Steering Group explains: “IDF has a strategic objective to foster mutually beneficial partnerships with other organizations. Hence, IDF will continue to focus strongly on building synergistic collaborations with other international standardization organizations to deliver standards-based solutions that facilitate the international flow of dairy nutrition.”

 “Our long-standing cooperation with IDF supports the ISO Strategic Plan 2011-2015 objective of “fostering partnerships that further increase the value and efficient development of International Standards” and our connection with IDF helps ensure the relevance of our work to the global dairy industry and research community. We are looking forward to a successful IDF/ISO symposium”.

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