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Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its history.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Computerized system validation (CSV) is the process of testing/validating/qualifying a regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
Medical transcription, also known as MT, is an allied health profession dealing with the process of transcribing voice-recorded medical reports that are dictated by physicians, nurses and other healthcare practitioners. Medical reports can be voice files, notes taken during a lecture, or other spoken material. These are dictated over the phone or uploaded digitally via the Internet or through smart phone apps.
The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
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Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug. As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard.
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Clinical quality management systems (CQMS) are systems used in the life sciences sector designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities, tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The premise of a CQMS is to bring together the activities led by two sectors of clinical research, Clinical Quality and Clinical Operations, to facilitate cross-functional activities to improve efficiencies and transparency and to encourage the use of risk mitigation and risk management practices at the clinical study level.
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... lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance
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An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Emcure Pharmaceuticals Limited is an Indian multinational pharmaceutical company headquartered in Pune. Emcure's product portfolio includes tablets, capsules and injectables. The company is a major producer of HIV antivirals, as well as gynaecology and blood therapeutic drugs.
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
CPC Scientific is a biotechnology company that manufactures peptides. The company provides a number of products and services to academic researchers and pharmaceutical industries, including research- and GMP-grade custom peptides.
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
References
- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 "Chapter 4. Documentation" (PDF). Volume 4. Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use (Report). Brussels: European Commission, Health and Consumer Directorate-General. 2010. Archived (PDF) from the original on 19 July 2022. Retrieved 15 October 2022.
- 1 2 3 4 5 6 7
This article incorporates public domain material from "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS". U.S. Food and Drug Administration. April 1999. Archived from the original on 24 September 2020. Retrieved 15 October 2022. - 1 2 3 4 5 6 7 8 9 WHO Expert Committee on Specifications for Pharmaceutical Preparations (2011). "Annex 3. WHO good manufacturing practices for pharmaceutical products: main principles" (PDF). Forty-fifth Report (PDF) (Technical report). WHO Technical Report Series. World Health Organization. 961. Archived (PDF) from the original on 1 September 2022.
- 1 2 3 4 5 6 "ICH Official web site : ICH". www.ich.org. Retrieved 7 March 2023.
- 1 2 3 4 5 6 European Commission Directive 2003/94/EC. (Article 9)
- 1 2 "Part I, Chapter 6 Quality Control" (pdf), The rules governing medicinal products in the European Union, vol. 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use., 1 June 2006, p. 3
- 1 2 3 4 5 "Code of Federal Regulations Title 21". U.S. Food and Drug Administration. 21CFR211 Subpart J. Retrieved 7 March 2023.
- ↑ US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
- 1 2 3 Japan MHLW. Ministerial Ordinance No. 169, 2004, "Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents" (Chapter 2, Section 2, Article 8, Paragraphs 2 and 4) Archived 22 July 2011 at the Wayback Machine – Accessed 7 January 2011
- 1 2 3 4 5 Hurd, Don (2010), Good Documentation Practices (PDF), et al., Premier Validation, pp. 11, 17, 30, 39, ISBN 978-1-908084-00-2, archived (PDF) from the original on 13 November 2012
- ↑ US FDA. "Warning Letter" UCM271708. Observation #1 – Accessed 27 June 2013
- ↑ Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a – Accessed 1 June 2011
- ↑ US FDA. "Warning Letter" FLA-99-29
- ↑ US FDA. "Warning Letter" UCM075960 – Accessed 4 February 2010
- ↑ US FDA. "Warning Letter" UCM066113
- 1 2 3 US FDA. "Warning Letter" UCM069041
- ↑ US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A
