Quality Assurance (1) - Quality Assurance(QA Management...

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Quality Assurance (QA) Management Procedures In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defective manufactured products; procedures on training for your staffs and many other procedures according to your need . All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately . SOP list Writing Standard Operating Procedure This SOP describes standard SOP format that you can create and use immediately for your quality procedures. This SOP has instructions on how to write a formal Operating Procedures for your systems which your people can follow everyday . GMP Documents In this SOP you will find all type of quality and Technical/Master file documents to build up a good quality management system for your manufacturing sites, definition of documents, their classification, approval requirements and retention requirements. This procedure has schematic diagrams for your understanding of how different types of documents are prepared and stored in a typical documentation database . Quality Documentation Change Control This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this SOP you will also find numbering systems of different quality documents like audit files, SOPs, forms, manuals, training files, QA agreements, project files etc and their effective archiving system . Documentation Rule This SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction technique of incorrectly entered data or information . Document Control In this SOP you will find mainly the role of document control officer during the initiation, creation, circulation and approval of new quality related documents. It also describes the procedure of modification and review of existing document using a documentation database. Management of existing and superseded documents is also a part of this procedure. You will see all the forms referred during the instruction are attached at the end of the procedure .
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Master GMP Documents This SOP particularly focused on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market. This SOP gives instruction on their
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