Development Assurance process requirements validation

Titled Guidelines for Development of Civil Aircraft and Systems , this document addresses the development process of aircraft systems and the Development Assurance processes of (a) validation of requirements and (b) verification of the design implementation. 

Regulatory professionals too often assume that any analytical method can undergo the steps necessary to validate its use in marketing a pharmaceutical product. In many cases the need for validation of a particular analytical method is often revealed late in the drug development process by corporate regulatory and quality assurance (QA) professionals who are responsible for compliance with the regulatory requirements associated with product registration. Commonly these individuals view the requirements and parameters of the validation processes as independent of the actual analytical chemistry and technical objective of the method itself. 

Future authenticity testing of cocoa butter and chocolate products is likely to follow defined paths. To assure the authenticity of cocoa butters databases of the composition of the relevant fats will be required, constructed from a statistically significantly number of samples of proven provenance and processing history. Analyses must be carried out using internationally validated methods and characterized reference materials by a number of respected laboratories. Scientific co-operation within the European Union is beginning to develop such approaches in ensuring the authenticity of other foods such as olive oil. 

The manufacture of sterile products is universally acknowledged to be the most difficult of all pharmaceutical production activities to execute. When these products are manufactured using aseptic processing, poorly controlled processes can expose the patient to an unacceptable level of contamination. In rare instances contaminated products can lead to microbial infection resulting from products intended to hasten the patient s recovery. The production of sterile products requires fastidious design, operation, and maintenance of facilities and equipment. It also requires attention to detail in process development and validation to ensure success. This chapter will review the salient elements of sterile manufacturing necessary to provide acceptable levels of risk regarding sterility assurance. 

The preparation of any pharmaceutical product requires controls over the production operations to assure the end result is a product that meets the required quality attributes. The methods utilized for this control are supported by formalized validation studies in which proof of consistency is demonstrated by appropriately designed experiments. The definition of appropriate operating parameters is the primary objective of the development activities and is further confirmed during scale-up to commercial operations. The validation supports that the routine controls applied to the process are appropriate to assure product quality [36], This is typically accomplished in formalized validation activities in which expanded sampling/testing of the product materials is performed to substantiate their uniformity and suitability for use [30],... 

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