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Documentation during product development

There should be more specific guidelines regarding the documentation during product development. As such there is a back calculation of documentary requirements as requirements of documents at the stage of IND application. This makes a more compliance oriented documentation. and not realistic documentation.:smiley:

Dear can u be more specific to your question? You are talking about the product development or asking for some tips for the fake documents, Anyway if you are really interested to improve the documentation and want to do product development scientifically then i can help you.
Product development involves the write up of development protocol before conducting trials. Its an approved document stating how Product development will be conducted, including Background, proposed master formula, product characteristics required by marketing, proposed processing technique, Justification of ingredient used, Justification of ingredient quantity used, allowable limits of ingredients in formulation, proposed specification for raw material, finished product, packaging, justification of packaging material selection, analytical method validation protocols, stability protocols for lab scale batches and proposed validation work on lab scale batches. After conducting trials a technical Report Called Development pharmaceutics is written and approved that states about the experiences and observations during development stage. This covers observation and experiences during formulation, analytical method development, technical report analytical method validation and technical stability report.

Product Development usually begins when active chemical entityhas been shown to process the necessary attributes for commercial product. The product development activities for the active chemical entity, formulation, and process form the foundation upon which the subsequent validation data are built.

1)Formulation development
2)Process development

Mr.Shahid is absoluetly right, IN NPD, the development prortocol and Development pharmaceutics should be develop at initial stage and all the observations , changes and outstanding items must be log in subjected documents.