Analytical outsourced

Partial or complete re-validation is another precedented approach to method transfer. Those variables described in method validation guidance documents (ICH Q2B, 1996 USP, 2012c) that are likely to be impacted by method transfer, should be assessed and documented (transfer or validation protocol). Agut et al. (2011) indicated that, in the changing industry model with the increased outsourcing of R and D activities (alliances, outsourcing, etc.), method re-validation may constitute, in some cases, an efficient approach when the transfer is performed from the Analytical Development Laboratory of an external partner who does not share exactly the same environment (validation standards, analytical culture or traditions , equipment, etc.). ... 

Shanley, A., Thomas, P., Wagner, M. V., Ciurczak, E. Lessons from Heparin. Avoiding future drug quality disasters will require closer control over raw materials, use of more powerful analytics and IT, and a Quality by Design approach. Pharmaceutical Outsourcing, 2008. http //www.pharma manufacturing.com/articles/2008/123.html. Accessed on 17th July 2012. 

Biopharmaceutical companies are highly diverse not only in their products but also in their size, capabilities, and approaches to development. Some biopharmaceutical companies (especially small companies) outsource part or most of the analytical work, some outsource manufacture and filling, and some invest and develop expertise to do everything in their own facilities. Most biotechnology companies are small, and sometimes it is faster and more cost-effective to outsource a task that requires expertise or expensive pieces of laboratory equipment not available in the company. Nevertheless, the analysts in the company will... 

Of course, technical departments of excipient distributors offering additional services involving further processing or handling of exposed material must be staffed with technicians such as analytical chemists, microbiologists, etc., unless they are outsourcing these functions to contract laboratories. 

Outsourcing the development, validation, and performance of analytical methods in recent years has become a popular means to facilitate movement of product through the development process. A recent industry survey reported that the vast majority (86%) of the companies responding say they outsource analytical methods development to contract laboratories. Twenty-five percent of the responding firms indicated that they often or always contract out stability testing on development compounds [37]. There are important criteria to follow in working with contract laboratories to ensure that their methods validation procedures yield results that are consistent with those of the client company [38]. This topic will be discussed later in this chapter. 

In recent years, the International Conference on Harmonization (ICH) has published two documents that serve as expert guidance on analytical and related validation [53,54], As part of the outsourcing process, the client and provider should review these and related regulatory guidances (e.g cleaning validation) to ensure that there is a mutual understanding and agreement on the scientific basis of methods validation. 

Analytical methods validation is a critical component of the entire company validation program. A method is not declared acceptable until a collaborative crossover study is conducted between two development laboratories and at least one quality control laboratory to ensure proper precision, accuracy, and efficiency. In the new world of outsourcing, it is imperative that an analytical crossover study be conducted between the client and supplier before any work is begun on dosage form development. 

Scull, J. R. Outsourcing analytical testing for non-clinical studies. Contr Pharm Jan JFeb. 20-24 (2000). 

Although the scope of application continues to grow, the routine use of LC/MS technologies are now embraced by pharmaceutical researchers. Standard methods that incorporate highly specialized features are routinely developed for a variety of novel applications. Furthermore, many LC/MS applications that deal with quantitative bioanalysis (i.e., pharmacokinetics studies) are frequently outsourced to contract analytical laboratories. Thus, the routine use of LC/MS is a benchmarked commodity for drug development. 

Outsourcing strategies offer a highly flexible and adaptable strategy for clinical development support. This approach to drug development generally involves the use of contract research organizations (CROs) and contract analytical laboratories, which perform a variety of specialized clinical development-based functions. This practice has... 

Outsource regularly used in-house services that provide no competitive advantage, for example IT and computing, information library support and routine analytical services, by agreeing an ongoing service contract with a specialist organisation. 

Other essential, but non-core analytical services, for instance simple elemental analysis, can easily be outsourced, as they are hardly ever rate determining in R D, and in addition a rapid turn around in testing is available from competent companies. Outsourcing does not necessarily mean that the work will be done off site. For instance, a visiting contractor can carry out routine environmental analysis of very small quantities of metals in the plant effluent, as is the case with other plant services. 

The R D Manager must ensure that the cost for the analytical support is in the budget for each project. Monitoring the cost and the use of analytical services is an essential task in budgetary control as it is easy for an R D team to run into overspend rapidly. It helps if data is provided to team leaders and chemists on the cost of the methods available in the analytical services group or from the outsourcing agency. 

If the study being outsourced is a pharmacokinetic or clinical pharmacology study, does the CRO have analytical laboratory facilities and expertise appropriate for the analysis of blood samples Can your analytical methods be transferred to their laboratories and validated or will samples be shipped to the sponsor for analysis ... 

Analytical chemistry and formulation development and characterization are aspects of manufacturing activities however, these functions are critical for the successful completion of many non-clinical and clinical research studies. The section on outsourcing of manufacturing provides a summary discussion on analytical chemistry and formulation development. 

Wiseman D, Griffiths KL. Implementing statistically designed experiments in analytical method validation. Am Pharm Outsourcing September/October 2004 13-25. 

Boudreau SP, McElvain JS, Martin LD, Dowling T, Fields SM (2004) Method validation by phase of development an acceptable analytical practice. Pharm Technol 28, pp 54-66 Sixsmith DG (2001) Outsourcing resources third-party technology transfer. Pharm Tech, pp 58-62... 

For analytical testing, the BPI may refer to a separate analysis instruction designed to test the preparation or the specific dosage form. When analysis is outsourced, the BPI may mentimi that a sample should be sent to the approved laboratory. 

A pharmacy with adequate laboratory facilities will be able to perform analytical quality control tests in-house. In that case the necessary analytical instructions are part of the documentation system. In other cases it may be necessary for a pharmacy to outsource its analytical testing to an external laboratory. Then it is necessary to have a copy of the analytical instructions, including the key acceptance criteria. In this scenario it is paramount that a Service Level Agreement (SLA) or Technical Agreement is in place between the pharmacy and the laboratory (for SLA see Sect. 33.9.1). 

---