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As per available reports about 36 Relevant Journals, 40 Conferences, are presently dedicated exclusively Pharmaceutical documentation and about 203 articles are being published on documentation
Documentation is the key to GMP compliance and traceability of all development, manufacturing and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. This helps provides explanation and examples of the key documents, required for pharmaceutical development, manufacturing processes, laboratory testing and also those required for CRM sections of a regulatory dossier. It illustrates how the documents are linked and controlled through the quality management system and provides useful tips for document control and management to keep them current and includes Good Manufacturing Practices: The Gap within, Current Regulations and Quality Standards, Current GMP Guidelines (cGMP), The Role of 'c' in cGMP, Storage, Distribution
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Scope and Importance:
Quality is always an imperative prerequisite when we consider any product. It becomes primary when it relates to life saving products like pharmaceuticals. Although it is mandatory from the government and regulatory bodies but it is also a fact that quality of a pharmaceutical product cannot be adequately controlled solely by pharmacopoeia analysis of the final product. Today quality has to be built in to the product right from its inception and rigorous international environmental, safety and regulatory standards need to be followed. Validation had proven to be an important tool for quality management of pharmaceuticals.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, instructions to follow including active drug substances, is legally mandatory. Documentation is the key to GMP compliance and traceability of all development, manufacturing and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. The GDP can be defined as “Good documentation practice is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. Clearly written documents prevent errors of various activities in Pharma each and every activity is written in specific documents such as SOPs and strictly followed. Spoken communications may be create errors so that all important documents such as Master formula record , procedure and record must be free from errors and Documented.
Market Analysis:
The market research available can provide investors and analyst credible information on the direction of pharmaceuticals and pharmaceutical industry is one of the largest and most advanced among the developing countries and it is 3rd largest pharmaceuticals market by 2020 and the pharmaceuticals industry accounts for about 2.4% of the global Pharma industry by value and 10% by volume.
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This page was last updated on February 15, 2026
