Topical products quality assurance

Throughout the development process, it is important to maintain a high level of quality. The application of systematic quality assurance (QA) in the research and development (R D) portion of topical product development is necessary to facilitate registration and also acts as... 

Part I presents aspects of antimicrobial product evaluations from three important perspectives. First, a chapter on developing effective antimicrobial products provides a broad view approach in developing topical antimicrobials. These views include marketing, science, and quality assurance. They include objective aspects, including antimicrobial effectiveness, label claims, and quality control subjective aspects, such as perceived ease of use, feel, fragrance and shared professional beliefs, such as value of an iodophor, a chlorhexidine gluconate, or triclosan products. 

A very important topic is nally the documentation of all steps and measurements to be able to trace back the starting material, the exact location of the eld, any treatment with agrochemicals, and the special circumstances during the cultivation period. Quality assurance is only possible if the traceability is given and the personnel is educated appropriately. Certi cation and auditing of the production of essential oil bearing plants is not yet obligatory, but recommended and often requested by the customer. 

Finally, the really important topics of fabrication and quality assurance of the product are addressed. As was stated earlier, the composite materials and structures are often fabricated at the same time, so the fabrication process and the skill with which it is executed can make or break the design work. While this is true to some extent for all materials, it is much more important for composites. Allied to this is the topic of quality... 

The European Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients [2] describes the following list of topics to be covered in a product file, depth and interpretation depending on a risk assessment (see Sect. 21.6.3) ... 

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