Excipient Auditing
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The document discusses good manufacturing practices (GMP) for excipient suppliers. It provides guidance on qualifying excipient suppliers, ensuring traceability of excipients throughout their lifecycle, assessing supplier GMP conformance, and evaluating significant changes in excipients. The document also summarizes International Pharmaceutical Excipients Council (IPEC) guides on GMP auditing practices for excipient manufacturers and distributors.
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The document summarizes the new Odoo Warehouse Management System. It discusses the global operations view, incoming and outgoing policies, and removal and put away strategies. Key points include barcode scanning for validation, routes to apply procurement and push rules, dropshipping capabilities, and options for receiving, shipping, and logistic strategies like FIFO, LIFO on locations. An advanced talk on the WMS is also announced.
Pharmaceutical, Bulk Drugs and Medicine Manufacturing Industry (Production, F...
Quality control and quality assurance are vital in this industry. Many production workers are assigned full time to quality control and quality assurance functions, whereas other employees may devote part of their time to these functions. For example, although pharmaceutical company sales representatives, often called detailers, work primarily in marketing, they engage in quality control when they assist pharmacists in checking for outdated products.
Advances in manufacturing processes are also impacting the industry. While pharmaceutical manufacturers have long devoted resources to new drug development as a source for future profits, firms are increasingly realizing that improvements throughout the drug pipeline are needed to stay competitive.
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Gmp final 97 03
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP and explains that GMP aims to ensure consistent production of quality products through established processes and quality control. Key aspects of GMP covered include organization and personnel qualifications, facility and equipment design, material management, production operations, quality control testing, and documentation. Maintaining high standards of hygiene, sanitation, maintenance and training are emphasized. The goals of GMP are to minimize risks like contamination, incorrect dosing, and protect patient safety.
Pharma industry an overview
(This is an extract from the lecture delivered by Shyamsunder Panchavati on 2nd September 2010 at Hyderabad)
Human being lives in whirlpool of Industries. All the industries revolve around the living beings specially the human beings. One industry or profession that keeps the human being fit enough to wither the whirlpool and keeps the industry going is the Medical Profession. Hence the Medical Profession occupies the high pedestal in this world.
View the abstract at
http://capacitybuildingdevelopment.blogspot.com/2010/09/pharmaceutical-industry-overview_06.html
Pharmaceutical Industry
Pharmacy is the science and practice of preparing and dispensing drugs. The name is derived from the Greek word for drug, "pharmakon". Pharmacy began in Australia with the supply of medicines by military surgeons and traders in the 1820s. The first pharmacy was established in 1825 in Launceston. Formal separation of medicine and pharmacy occurred in 1908 with the Pharmacy Act. Most early medicines were natural compound mixtures until the 1900s when manufactured drugs like aspirin and phenacetin emerged. The development of antibiotics and antipsychotics in the 1940s-50s revolutionized drug treatment. Pharmacy education moved to the University of Tasmania in 1978 where it is now ranked highly.
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The document discusses Good Manufacturing Practices (GMP) with a focus on quality control. It outlines key aspects of GMP compliance that should be reviewed during an on-site quality control laboratory inspection, including documentation, personnel qualifications, equipment and instrument validation, testing procedures, data verification, and facilities and environmental monitoring. The inspection aims to ensure proper implementation of quality standards and systems across all aspects of the quality control process.
Intro to cGMPs: The Building Blocks for GFSI Compliance
Current Good Manufacturing Practices (cGMPs) provide the necessary environmental and operating conditions for the production of high quality and safe foods. They are also the building blocks for GFSI-recognized food safety and quality standards, including SQF, BRC, FSSC 22000, and other global standard schemes.
This webinar on cGMPs for GFSI was co-hosted with founder and partner of Food Industry Consulting, Sonia Akbarzadeh, on October 7 at 10:00am MDT.
Sonia covers cGMP basics and how you can use them as building blocks for GFSI compliance.
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Good Laboratory Practice (GLP) guidelines provide standards for laboratory experiments and tests performed to support research, nonclinical studies, and regulatory submissions. The key goals of GLP are to ensure quality, reliability, and integrity of data through adherence to standard operating procedures, trained personnel, appropriate facilities and equipment, records management, and quality control. GLP aims to promote valid and robust research that can be reproduced internationally and supports regulatory review and decision making.
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This document discusses an investigation into adverse drug reactions caused by two different drug manufacturers using the same active pharmaceutical ingredient (API). The investigation found fundamental failures in good manufacturing practices at both the API manufacturer and drug product manufacturers. Specifically, the API manufacturer did not adequately validate and control their manufacturing process or water systems. This likely led to endotoxin contamination during the final washing steps. Samples from the API batches were found to contain pyrogenic and endotoxin levels above acceptable limits. Around 200 adverse drug events were reported after administration of the contaminated drugs. The manufacturers faced recalls, market withdrawals, and import detentions until major changes were made to comply with good manufacturing practices.
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Quality assurance is the totality of arrangements to ensure pharmaceutical products are of the required quality. It includes in-process quality checks, validation of facilities, equipment and processes, complaint handling, and stability studies. Regulatory compliance describes conforming to rules like specifications, policies, standards or laws. For pharmaceutical products, this includes complying with requirements for approvals in countries or regions like the US, Europe, and India.
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct
Quality assurance is essential for ensuring pharmaceutical products meet quality standards for their intended use. It involves establishing controls throughout the development and manufacturing processes. This includes designing products based on GMP, GLP and other standards, specifying control operations in writing, and establishing in-process and finished product testing. Managerial responsibilities and change control systems are also important aspects of quality assurance. The goal is consistently producing products that conform to their marketing authorizations and regulatory requirements.
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct
Quality assurance is the totality of arrangements to ensure pharmaceutical products are of the required quality. It includes in-process quality checks, validation of facilities, equipment and processes, complaint handling, and stability studies. Regulatory compliance describes conforming to rules like specifications, policies, standards or laws. For pharmaceutical products, this includes complying with requirements for approvals in countries or regions like the US, Europe, and India.
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