Market validation

The cost and complexity of validation is often underestimated and can cause delays in bringing the product to market. Validation requirements for a project should be identified as early as possible in the project life cycle to ensure that adequate time and cost is allowed to complete them successfully. It is particularly important to establish the documentation required from suppliers and contractors working on the project, and the extent to which they will be required to play a part in the validation process. For example, if material certification is required for equipment components, these must be ordered from the supplier s own stockholders with the raw materials, and cannot be obtained retrospectively. 

The rapidly expanding requirements of the pharmaceutical industry, and the broadening areas of expertise contributing to the processes of R D, development, manufacturing, marketing, validation, surveillance, and in particular its innovative potential are increasing the demand for skilled manpower. 

Requirements for the notification of new substances, iiTespective of their potential for harm, before they can be placed on the market. Aim to ensure that a chemical placed on the market can be validly marketed m any EU state without duplicating authonzation. 

The marketing information primarily identifies either problems or opportunities. Problems will relate to your existing products and services and should indicate why there has been a decline in sales or an increase in returns. In order to solve these problems a search for possible causes should be conducted and one valid method for doing this is to use the Cause and Effect Diagram. Opportunities will relate to future products and services and should indicate unsatisfied wants. There are three ways of collecting such data by observation, survey, and experiment. 

Customers may have specific requirements that apply to the contract acquisition processes, such as limitation on profit, special quotation forms, validity of quotation, etc. VDA 6.1, for example, has a requirement for the marketing function to be incorporated into the operational organization. 

Others, however, suggest reorientation to more appropriate realms. The valid point is that uncorrected market failure may prevail. However, often the arguments for subsidies are misstated. Some suggest that the existence of inappropriate subsidies elsewhere justifies aid to those excluded. The preferable reaction to bad existing subsidies is their removal. Past waste cannot be recovered. 

The review of MRL applications is similar to that for centralised marketing authorisations conducted by the EMEA, in that rapporteurs are responsible for the hands-on evaluation, which is then reported back to the CVMP for consideration. If there are outstanding issues, a list of questions is forwarded to the applicant for his or her response. Otherwise, a formal opinion is prepared and presented to the Commission for legal implementation as a decision. The maximum time allowed to deliver a CVM P opinion is 120 days, excluding the time taken for an initial validation of the application and review of responses form the applicant where necessary. 

Three test batches of a chemical were manufactured with the intention of validating the process and having a new product to offer on the market. Samples were put on stability under the accepted ambient (25°C, 60% relative humidity) and accelerated (= stress 40°C, 75% rh) conditions cf. Section 4.20. One of the specification points related to the yellowish tinge imparted by a decomposition product, and an upper limit of 0.2 AU was imposed for the absorption of the mother liquor (the solvent mixture from which the crystalline product is precipitated) at a wavelength near 400 nm. 

Example 62 If a manufacturing process involves two raw materials, each defined by three sets of specification limits, and four pieces of equipment with one control knob, then a complete validation protocol would ask for (Three settings Lo, Target, Hi) (2 materials 3 specs + 4 machines 1 control) = 3 = 59 000 experiments, even without repetitions. This product would never reach the market if one did not employ experience and scientific rationale to simplify development by testing only the presumed critical issues, say a total of three specification points for 3 = 27 experiments. 

Today s ELN market is characterized by a number of niche providers, focusing their solutions on particular vertical markets, and general solution providers, delivering systems that are implemented across a broad range of disciplines. These two approaches are both very valid, having their own strengths and weaknesses. One trend that does seem to be emerging is a... 

Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market. The section concerning residue analytical methods was not fully finalized when the Directive was first adopted. There were no provisions for methods to determine residues from a.i. and relevant metabolites in soil, water, and air. The criteria for foodstuffs partly proved to be not helpful for the practice of assessment (e.g., with regard to reproducibility, ISO 5725 requires validation in at least eight independent laboratories). 

Retrospective validation uses historical information gathered in actual process runs to evaluate the process. For example, batch records can provide extensive data on column performance and analytical data of fractions and final product can provide valuable information on the efficiency of the chromatographic steps in removing contaminants. Chapman67 cautions that while retrospective validation is a valid and valuable approach, it is not meant to be retroactive — validation must be done before product is released to market. 

Of ultimate importance are the full reports of the clinical studies in humans and their results. These data will be treated statistically for their validity. The number of studies for a specific compound or combination of compounds will vary with the type of drug being tested, as will the number of tests needed to appraise relative or absolute safety and to clearly demonstrate efficacy. The basic requirement is the proof of safety and efficacy of the product being submitted under the NDA system. A drug that does not contribute to therapy, such as a new antihistamine that does not demonstrate greater safety or efficacy, or both, compared with drugs already on the market, will have a difficult or impossible time achieving approval. 

In this chapter, the regulatory requirements relating to data on development pharmaceutics and process validation will be discussed. The discussion will be limited to Marketing Authorization Applications (MAAs) for the European Economic Area and many central and eastern European countries. 

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