DOCUMENT A DOCUMENT is a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record. WHY DOCUMENTATION Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first. Due to the importance given to documentation in pharma "good documentation practices" is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Clearly written documents prevent errors of various activities in Pharma. PURPOSE OF DOCUMENTATION: Defines specifications and procedures for all materials and methods of manufacture and control. Ensures that all personnel knows what to do and when to do it. Ensure that authorized persons have all information necessary for release of product. Ensures documented evidence, traceability, provide records and audit trail for investigation. Ensures availability of data for validation, review and statistical analysis. Drug substance : Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. Drug product : Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. Exploratory Product Development Brief Many companies today utilize some form of a traditional phased-and-gated product development process, which originated more than 50 years ago. It hasn’t changed substantially since then. A phased-and-gated system creates multiple batches that slows down the overall speed of a product development project. When companies try to maintain a traditional phased- and-gated process in a changing environment, the product development team is unable to manage to the scope, timeline and budget approved at the outset. The result usually includes changing product requirements, unexpected problems, rework, schedule delays, breaking the budget and commercial failure. GOAL Develop Exploratory PD® (ExPD), which help companies achieve growth and improve product development success through an adaptive system. The primary goal of ExPD is to reduce uncertainty and risk by reducing the unknown. When organizations adapt quickly to the changing environment (market, technology, regulations, globalization, etc.), they reduce uncertainty and risk leading to product success. APPROACH The product development team needs an approach that allows them to adapt to change in customer needs, markets, competition, technology and more. ExPD proposes a new approach to developing products, using a two-pronged solution: 1) Treating product development from a comprehensive systems perspective