Manufacturing Information documentation

Clearly it is not feasible to describe all the chemicals that one could come across in all different types of work, nor would it be all that useful. In point of fact, in most jurisdictions it is mandatory that the manufacturer of a chemical used in the workplace must provide information to the user on the nature of that particular chemical, its potential hazard, and the steps that should be taken both to protect against it and to treat any emergency exposure that may occur. This information document is generally known as an MSDS (Manufacturer s Safety Data Sheet) and should be available to all concerned in any place where that chemical is in use. This book is not intended to usurp the MSDS. In all cases in which a strange chemical is in use, the MSDS should be consulted. This book is intended to acquaint the reader with some of the problems derived from ordinary, everyday chemicals. 

The objective briefly describes the purpose of the validation program. An additional objective is to provide supplemental manufacturing information beyond that recorded in the batch documents. 

Request for authorization to administer an investigational drug product to humans. INDs include structural formula, animal test results, and if available, prior human test results, manufacturing information, and the proposed clinical investigational plan. INDs must be submitted at least 30 days priorto the start of clinical trials FDA does not approved INDs but will notify applicants of issues within 30 days of receipt. The effective date of an IND is 30 days from the date of receipt by FDA s central document center unless a clinical... 

Manufacturing information. These data address the composition, manufacture, stability, and controls used for manufacturing the drug. This information is provided to document the sponsor s ability to produce and supply consistent batches of high-quality drug. 

The excipient manufacturer should develop plans that identify the responsibility for each design and development activity which is updated as necessary. Organizational and technical interfaces between different groups should be identified and the necessary information documented, transmitted and regularly reviewed. 

The guidance document brackets the manufacturing dates as between January 1, 1975 and July 1,1979, dealing with corrections to the initialinventory only. Since EPA has adapted this document for dealing with corrections to PMN submissions as well, one can assume that EPA would want all manufacturing information to the date of the correction. 

Part of this information is usually available (particularly in regard to the manufacturing and own use of the substance). However, information on the conditions of use down the supply chain must be collected externally through an interaction with the customers or customers associations. This interaction starts when the manufacturer or importer communicates the relevant information documented in the CSR to the downstream users (DU) to ensure safe use of the substance. This information is transmitted by means of the Safety Data Sheet (SDS) and the Exposure Scenarios (ES) attached [also known as the extended Safety Data Sheet (eSDS)]. 

Nowadays, the development of new products takes place almost continuously in 3D. However, derived 2D drawings are still considered the authoritative documents for manufacturing, quality assurance, assembly and other downstream processes. These 2D documents often contain valuable technical manufacturing information, such as product and manufacturing information (PMl), material properties bills of material, and annotations. However, 2D drawings discover fundamental deficits in transparency and concurrency and are going to be replaced by appropriate 3D data. 

Information Manufacturing information is usually included on the fabrication drawing or attached documents. This document details the following ... 

MSDS Material Safety Data Sheet - a document that provides pertinent information and a profile of a particular hazardous substance or mixture. An MSDS is normally developed by the manufacturer or formulator of the hazardous substance or mixture. The MSDS is required to be made available to employees and operators whenever there is the likelihood of the hazardous substance or mixture being introduced into the workplace. Some manufacturers prepare MSDS for products that are not considered to be hazardous to show that the product or substance is not hazardous. 

The MSDS from the chemical manufacturer identifies hazards for entry in the spreadsheet in columns 8 and 10. This is performed for all chemicals that are associated with the process, if the analysis is hmited to a process, or for a plant. The spreadsheet may be filled out variously according to convenience and effectiveness. It is practically impossible to get all needed information from documentation alone. A plant walk-through is advised for viewing operating conditions as they exist, for interviewing operators about the risk concerns that they have, and about the operability of safety and mitigation systems. These results are entered into the spreadsheet. 

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