tag:blogger.com,1999:blog-2334391353227117572024-03-18T22:04:43.234-07:00Pharmaceutical Validationvalidation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributesPrincehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.comBlogger1243125tag:blogger.com,1999:blog-233439135322711757.post-48210940333550379912023-07-13T01:49:00.003-07:002023-07-13T01:49:59.176-07:00Pharmaceutical Validation Documentation RequirementsPharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe for use. Validation documentation is a critical component of the validation process. It provides evidence that the manufacturing process has been carried out according to the predefined procedures and that the final product meets the desired quality standards. Princehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com9tag:blogger.com,1999:blog-233439135322711757.post-85465930080838513802023-06-27T01:41:00.000-07:002023-06-27T01:41:10.381-07:00Change Control and pharmaceutical Validation The pharmaceutical industry is one of the most heavily regulated industries in the world, and for good reason. The medications that are produced in this industry are designed to treat a variety of illnesses, and it is vital that they are safe, effective, and consistent. To ensure this, there are strict guidelines and regulations that pharmaceutical companies must follow when it comes to thePrincehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com3tag:blogger.com,1999:blog-233439135322711757.post-46986507284813764682023-06-26T23:23:00.001-07:002023-06-26T23:23:11.133-07:00Pharmaceutical Validation Team Roles and Responsibilities Pharmaceutical Validation Team===Validation is a critical component of pharmaceutical manufacturing and ensures that products meet established quality standards. The pharmaceutical validation team plays a crucial role in ensuring that products meet regulatory requirements, are safe, and effective. This article will provide an overview of the roles and responsibilities of the pharmaceutical Princehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-19597478818556755712023-06-26T23:15:00.001-07:002023-06-26T23:15:27.984-07:00Quality Risk Management in Validation Quality Risk Management in ValidationQuality risk management in validation is an essential aspect of ensuring that validated processes are maintained and effective in their intended use. Validation is the process of demonstrating that a product or process is suitable for its intended use. Quality risk management is a process that helps organizations to identify potential risks and take Princehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com1tag:blogger.com,1999:blog-233439135322711757.post-33922042075603857352023-06-26T23:06:00.002-07:002023-06-26T23:06:18.762-07:00Risk Assessment in Pharmaceutical Validation Risk assessment is a crucial component of pharmaceutical validation, helping to identify and evaluate potential risks associated with the manufacturing processes, equipment, systems, and facilities. It is a systematic and proactive approach that enables organizations to prioritize validation activities, allocate resources effectively, and implement appropriate risk mitigation measures. HerePrincehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-76919452907214645782023-06-26T23:04:00.002-07:002023-06-26T23:04:35.631-07:00Validation Life Cycle Approach The validation life cycle approach is a systematic and comprehensive approach to pharmaceutical validation that encompasses the entire life cycle of a process, equipment, system, or facility. It involves planning, designing, implementing, testing, and continuously monitoring and improving the validated state to ensure ongoing compliance with regulatory requirements and product quality Princehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-72933752557118399092023-06-26T23:03:00.001-07:002023-06-26T23:03:22.424-07:00Regulatory Requirements for Pharmaceutical Validation Regulatory requirements for pharmaceutical validation vary depending on the country or region. However, several key regulatory authorities and guidelines provide the foundation for validation requirements. Here are some of the major regulatory authorities and guidelines that outline the regulatory requirements for pharmaceutical validation:U.S. Food and Drug Administration (FDA):FDA Princehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-13697828058145206982023-06-26T22:15:00.001-07:002023-06-26T22:15:31.774-07:00Validation protocol for Ethylene oxide Sterilization Here's a basic outline for a validation protocol for ethylene oxide sterilization:Title Page:Include the title of the validation protocol, organization name, document number, and effective date.Table of Contents:List all the sections and subsections of the validation protocol with their respective page numbers.Objective:Clearly state the objective of the validation protocol, which is to Princehttp://www.blogger.com/profile/18347371720617709214noreply@blogger.com1tag:blogger.com,1999:blog-233439135322711757.post-69893165094244103792018-05-17T00:24:00.001-07:002018-05-17T00:24:15.488-07:00Cambrex Reports Expansions at its High Point, NC Facility
On May 15, 2018, Cambrex reported that it had completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite. The new 400-sq.-ft. suite includes two 2000 L glass-lined reactors and a Hastelloy C22 filter dryer, allowing the manufacture of batch sizes ranging from 10–100kg under cGMP conditions for clinical-phase projects. Unknownnoreply@blogger.com56tag:blogger.com,1999:blog-233439135322711757.post-24802772842718980082018-05-16T04:24:00.001-07:002018-05-16T04:24:12.684-07:00Irish engineering group wins major contract in Sweden
Irish engineering and construction management firm DPS has won a major contract from the global pharmaceutical company AstraZeneca.
DPS, which employs over 1,300 people, is to provide engineering, procurement, construction management and validation (EPCMV) services for small and medium sized projects on AstraZeneca’s pharmaceutical site in Södertälje, Sweden.
The contract win means that DPS willUnknownnoreply@blogger.com9tag:blogger.com,1999:blog-233439135322711757.post-77546034401504685902018-05-15T12:24:00.001-07:002018-05-15T12:24:10.278-07:002 Day Course: FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (Boston, MA – June 25-26, 2018) – ResearchAndMarkets.com | Technology
This seminar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it Unknownnoreply@blogger.com4tag:blogger.com,1999:blog-233439135322711757.post-1536803974396235622018-05-15T08:24:00.001-07:002018-05-15T08:24:16.388-07:00DPS Group Wins Contract in Sweden from AstraZeneca
As a result of winning this contract, DPS Group is now establishing an office in Sweden, which will be used initially to service AstraZeneca exclusively but later to service other clients in Sweden.
DPS Group CEO Frank Keogh said: “DPS are delighted to have won this contract and we are confident the combination of a substantial local office and local partners in Sweden, as well as our Unknownnoreply@blogger.com2tag:blogger.com,1999:blog-233439135322711757.post-71041320281717987582018-05-15T06:24:00.001-07:002018-05-15T06:24:12.729-07:00AstraZeneca (AZN) Partnered with DPS Group in Sweden for Construction Contract
The UK researched-based biopharmaceutical company, AstraZeneca PLC (NYSE:AZN) partnered with DPS Group, the global and European based engineering, consulting and project management company, in a construction contract.
The contract is specific for AstraZeneca’s pharmaceutical site in Swedan.
The terms and condition of contract was not disclosed by both companies even the value, however, DPs GroupUnknownnoreply@blogger.com10tag:blogger.com,1999:blog-233439135322711757.post-48071796379779433032018-05-15T04:24:00.001-07:002018-05-15T04:24:29.474-07:00AstraZeneca (AZN) Partnered with DPS Group in Sweden for Construction Contract
The UK researched-based biopharmaceutical company, AstraZeneca PLC (NYSE:AZN) partnered with DPS Group, the global and European based engineering, consulting and project management company, in a construction contract.
The contract is specific for AstraZeneca’s pharmaceutical site in Swedan.
The terms and condition of contract was not disclosed by both companies even the value, however, DPs GroupUnknownnoreply@blogger.com1tag:blogger.com,1999:blog-233439135322711757.post-32903791339340976642018-05-15T00:24:00.001-07:002018-05-15T00:24:37.504-07:00CGMP Violations Found at India FacilityFDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
FDA sent a warning letter, dated April 24, 2018, to Goran Pharma Private Limited after an inspection of the company’s Sihor, Gujarat, India facility found deviations from current good manufacturing practices (CGMPs). A variety of violations found during the inspection included failure to Unknownnoreply@blogger.com5tag:blogger.com,1999:blog-233439135322711757.post-77645367717768679552018-05-14T13:34:00.001-07:002018-05-14T13:34:36.992-07:00Calibration And Validation Of A Headspace Gas Chromatographic Method – Covering the Printing Inks, Coatings and Allied IndustriesPallavi Gupta, Ruchi Gupta, Pinaki Ranjan Samanta and Pradeep Shah, Uflex Ltd (Chemical Division), Noida, India05.11.18
A simple and sensitive method for the simultaneous determination of methanol, ethanol, iso propyl alcohol(IPA), methyl ethyl ketone (MEK), methyl isobutyl ketone (MIBK), n-propyl alcohol (n-PA), ethyl acetate (EA), n-butanol, n-propyl acetate (n-PAc), toluene and ortho-xylene Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-233439135322711757.post-52989391312130992452018-05-14T03:34:00.001-07:002018-05-14T03:34:17.584-07:00Sichuan Kelun Pharmaceutical Automates Oncology Clinical Trial Set Up and Management with Clinical One Randomization and Supplies Management Cloud Service, Business News
CHENGDU, China, May 14, 2018 /PRNewswire/ — Oracle Health Sciences today announced that Sichuan Kelun Pharmaceutical Research Institute Co., Ltd (“Kelun”) has implemented Oracle Health Sciences Clinical One Randomization and Supplies Management Cloud Service to fully automate the set up and management of its multi-site, double blind colorectal cancer study.
The China Food and Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-47870501038594388252018-05-12T01:34:00.001-07:002018-05-12T01:34:11.485-07:00Pharma Manufacturer Gets a Dose of Operational EfficiencyUnknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-4437143808857719182018-05-11T11:14:00.001-07:002018-05-11T11:14:13.270-07:00Best Practices for Shipping Single-Use Systems
Image Courtesy of Sartorius Stedim BiotechAs single-use processing equipment becomes a more prominent part of biopharmaceutical development and manufacturing, a clear understanding of risk management and testing requirements are needed. Regulatory guidelines are not prescriptive, forcing manufacturers to develop clear strategies that will ensure that product safety and efficacy are maintained Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-50290343610112201822018-05-11T05:14:00.001-07:002018-05-11T05:14:10.532-07:00Two day Process Validation Guidance Requirements Workshop: FDA and EU Annex 15 – Qualifications and Validation (Boston, United States – July 7th-8th, 2018) – ResearchAndMarkets.com | Technology
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
These guidances align Process Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-64118601594431508152018-05-10T11:14:00.001-07:002018-05-10T11:14:22.170-07:00Two day Process Validation Guidance Requirements Workshop: FDA and EU Annex 15 – Qualifications and Validation (Boston, United States – July 7th-8th, 2018) – ResearchAndMarkets.com | Business
DUBLIN–(BUSINESS WIRE)–May 10, 2018–The “Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop ” conference has been added to ResearchAndMarkets.com’s offering.
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-65193239434774960122018-05-10T09:14:00.001-07:002018-05-10T09:14:27.320-07:00MetroWest Business Digest for May 10, 2018 – News – MetroWest Daily News, Framingham, MA
Information Security Summit slated for May 24
MassBay Community College and Towerwall will hold the sixth annual Information Security Summit from 7:30 a.m. to 1:30 p.m. May 24 at the MassBay Wellesley Hills campus, 50 Oakland St. Attendees will learn from industry experts as they share their experience and knowledge regarding guiding principles of information security, user awareness, training/Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-61319445792928137682018-05-10T01:14:00.003-07:002018-05-10T01:14:18.338-07:00Porvair offers validation services for pharmaceutical industryUnknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-69339443327324067012018-05-10T01:14:00.001-07:002018-05-10T01:14:17.906-07:00Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
Yada/shutterstock.comPart one of this article introduced the concept of sampling distribution of acceptance value (AV) in uniformity of dosage units (UDU) (1). With Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-233439135322711757.post-57197090331014137482018-05-09T13:14:00.001-07:002018-05-09T13:14:18.752-07:00Growing Adoption of Open Innovation Models in Pharmaceutical and Biotechnology Companies
Dublin, May 09, 2018 (GLOBE NEWSWIRE) — The “High Throughput Screening Market by Technology, Application, Product, End User – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.
The global high-throughput screening (HTS) market is projected to reach USD 21.69 Billion by 2023 from USD 14.87 Billion in 2018, at a CAGR of 7.8%.
The major factors driving the growth Unknownnoreply@blogger.com0