Existing Products

The validation of any process or product relies upon several supportive activities. Validation in the absence of these activities has only minimal utility, as it is only through the integration of these other practices that meaningful validation can be accomplished. Several of these activities are defined in CGMP regulations while others are an integral part of a company s organization structure or are closely associated with validation itself (11). 

Equipment calibration—The process of confirming the accuracy and precision of all measurements, instruments, etc. to ensure that the measured variable is being accurately monitored. Calibration includes demonstration of conformance to applicable national standards such as NIST, DIN, or BS for all key parameters. This is a universal CGMP requirement across the globe. 

Equipment qualification— An outgrowth of validation that focuses on equipment related aspects. There is no requirement for a formal separation of the activity into distinct elements, such as installation and operational qualification. It has become increasingly common in recent years to combine these activities under a single effort. For the sake of those who still separate the activities individual descriptions have been provided  

Installation qualification— Documentation that the equipment was manufactured and installed in accordance with the intended design. This is essentially an audit of the installation against the equipment specifications and facility drawings. 

Operational qualification—Confirmation that the equipment performs as intended entails evaluation of performance capabilities. It incorporates measurements of speeds, pressures, and other parameters. 

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Internal development is usuaHy recommended if the company has a unique process or product for an evolving market or a unique, less expensive process for an existing product, licensing is resorted to when entry is desked and no suitable acquisitions can be found but a Hcensor of a suitable process exists. 

Whatever hazardous materials are involved, whether they be new produces, an existing product in a new package type, hazardous waste, or any other hazard category, the proposed packaging and all conditions which are expected to be incident to its use should be reviewed... 

Product or Process Development—A company can develop a new product or process as a quasi-research effort with a toller while simultaneously building the in-house production capacity. This allows problems found in the toller s intermediate scale efforts to be fixed in the large-scale process and to reduce development time and costs. It may simply be a case of a company wanting to try new raw materials in a well-known process without disrupting existing production or establishing a pilot facility. Tollers can provide a way to achieve these activities in a parallel fashion. 

Testing conditions are not as constrained as for catalysts in an existing production unit, but other conditions may set some limits, like explosive range, start of a homogeneous reaction, corrosion, polymerization, etc. Literature should be searched for this limitation, in addition to other information on the main reaction. Literature gives much more information if interest is not limited to the main reaction but is extended to analogous processes as well. 

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. 

From these simple statements of need you need to gather more information and turn the requirement into a definitive specification. Sometimes you can satisfy your customer with an existing product or service, but when this is not possible you need to resort to designing one to meet the customer s particular needs, whether the customer be a specific customer or the market in general. 

What to do with existing product in production, in store, and in service... 

External communications quarterly and annual reports, press releases, new product announcements, existing product information and updates, customer newsletters, community newsletters, etc. 

Prepares studies of process cycles and systems for various product production or improvements or changes in existing production units prepares material and heat balances. 

In order for such an extensive project to remain manageable, certain requirements were necessary. Initially the data were confined to TPs, TSs, TPEs, and casting plastics. To be included in this group were the TSEs, reinforced plastics, foams, semifinished products, and others. Polymat completed its initial work in 1989. New plastics products on the market and updated additional information on existing products are continually added. Data no longer available are still accessible to the user in a memory file. 

Improve the existing product. Making small changes and improvements to a product already in the market to tackle a perceived problem such as an ingredient with known or suspected toxic effects. The product, manufacturing process and functionality remain basically the same. 

Provide new functionality. Rather than improving the existing product concept, find new ways of meeting the customer needs. For example, by converting the product into a service. 

Another way to think about this is in terms of shallow and deep innovation. Shallow innovation focuses on incremental changes to existing products and services. Shallow innovation can be quick to deliver and relatively low risk. The benefits may not be great, but they are easy to obtain. Deep innovation takes a hard look at the real user needs. It uses a thorough understanding of the way in which a product or service is used, and the benefits it delivers, to produce new concepts that can transform a market. 

Many companies treat environmentai issues as a threat, not an opportunity. A cost to be minimised, not a chance to create competitive advantage. When an externai pressure is appiied, the tendency is to circie the wagons and attempt to fight off the perceived threat. The company becomes stuck in a defensive posture where they cannot consider aiternatives. Smart companies see environmentai issues as an opportunity. If the existing product/solution is under pressure, there is a business opportunity in solving the problem. 

Let us consider a product developer who is trying to improve the taste of an existing product. The first question one could ask (and should ask before continuing) with the new product is does the new product taste different from the old product If trained panellists cannot establish a significant difference, it is hardly justifiable to do consumer tests, let alone launch the product on the market. A standard overall difference test is the triangle test (Fig. 38.1). In such a test one presents three samples, in no particular order, which should be tasted. Two out of the three samples are identical (e.g. the existing product, as a control) and the task is to identify the odd sample (the new product). If enough panellists correctly... 

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