Good Manufacturing Practices Articles
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Technical Review: European GMP Annex 1 – 2008 Edition
The GMP guidance for sterile manufacture was revised in 2003 to accommodate changes from various cleanroom standards and create a single unified cleanroom standard, ISO4644-1. The introduction to ISO 14644-1 states this as: Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal ...
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Assessing FDA's risk methodology at pharmaceutical manufacturing sites
This research analyses the US Food and Drug Administration's (FDA's) risk methodology used for inspecting pharmaceutical manufacturing sites. It reviews the procedures, regulations, and violations specified in FDA warning letters (WLs). In particular it focuses on the time period between 2004-2009, as the FDA transitioned and formalised this new approach to site inspections. One of the principal ...
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It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
The following is the summary of a noteworthy discussion from the 2019 GMP Academy Master Course – Particle Measuring Systems, Rome, Italy The first GMP Academy Master Course took place from November 26 – 28 at Particle Measuring Systems (PMS) in Italy. International experts met to share their knowledge and expertise of regulatory requirements and practical applications pertaining to ...
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Catching Up with GMP Requirements
This two-part blog series discusses current good manufacturing practices (GMPs) and how they can be applied to a continuous environmental monitoring system installed within a pharmaceutical manufacturing facility. Quality and Production teams can then establish new environmental monitoring understandings and harmonize with ...
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What is GMP?
Hundreds of millions of Americans rely on life-saving and sustaining medications and medical devices every day. Ensuring the drugs and devices that they depend on are not contaminated is critical for the health of the country, and the responsibility of the U.S. Food and Drug Administration (FDA). To address safety concerns in the medical, pharmaceutical, and food industries, the FDA ...
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More Careful Scrutiny Encouraged for Purification and Quantitative Testing of Nutritional Supplements
Recent case of selenium toxicity points to need for FDA to toughen regulations for supplements. MacFarguhar et al have written an excellent article in the Feb. 8, 2010 edition of the Archives of Internal Medicine entitled “Acute Selenium Toxicity Associated with a Dietary Supplement.” They report that in 2008 a chiropractor in Florida noted common symptoms of gastrointestinal illness ...
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The Benefits of Partnering with a Contract Manufacturing Organization (CMO) for Generic Pharmaceutical Companies
The generic pharmaceutical industry is fiercely competitive, with each company striving to add new products and expand its portfolio. However, not all companies possess the necessary resources to undertake such endeavours. Some lack the requisite experience in commercial-scale production using the latest technology, while others lack the capacity to ramp up manufacturing. ...
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Maintaining Quality in Stem Cell Products: ATMPs and Regulation (Series Part 2 of 4)
What are ATMPs? Stem cells are categorized as Advanced Therapy Medicinal Products (ATMPs) when undergoing substantial manipulation or when used for a different essential function. ATMPs are medicines for human use with gene, tissue or cell components. They can be classified into gene therapy medicines, somatic-cell therapy medicines, and tissue-engineered medicines, depending on how the medicine ...
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Ultra Low Temperature (ULT) Pharmaceutical Freezers
What is an Ultra Low Temperature Freezer? An ultra-low temperature freezer (ULT freezer) typically has a temperature range of -45°C to -86°C and is used for the storage of drugs, enzymes, chemicals, bacteria and other samples. They are available in various designs and sizes depending on how much storage is needed. An upright ULT freezer gives easy access for frequent use and a chest ULT ...
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Specification and calibration requirements for industrial scales in pharmaceutical applications
Introduction Performance and accuracy of industrial scales in pharmaceutical applications are covered by current Good Manufacturing Practices (cGMPs). Verification of proper operation of process scales is an important factor in finished product Quality Assurance (QA) programs. Incorrect weighing, additions of materials and components in validated processes of formulation, dispensing, and mixing ...
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Matrix Gemini Competency module keeps Healthcare manufacturer’s training needs on track case study
Ernest Jackson, a leading UK developer and manufacturer of medicated confectionery and vitamin pastilles, has adopted the Competency Tracker module from Autoscribe’s Matrix Gemini Quality Management Suite as part of its Environmental Health & Safety resources. The Competency Tracker is used to monitor the training status and needs of its 150+ staff to ensure that everyone gets the right ...
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Biocientifica SA develops a new high sensitivity RT-PCR kit for SARS-CoV-2
The Argentinian National Administration of Drugs, Food and Medical Technology (ANMAT) approved New kitfor the qualitative detection of the SARS-CoV-2 virus based on Real-Time RT-PCR technology. The Argentinian National Administration of Drugs, Food and Medical Technology (ANMAT) approved Schep SARS-CoV-2 RT-PCR Duo Biocientfica SA, an Argentinian biotechnology company developed this sensitive in ...
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Viral Vector Characterization: Why and How
Why need viral vector characterization? Cell and gene therapies for various rare diseases are currently undergoing clinical trials worldwide. The rapid development in this field has led to an increase in regulatory scrutiny and product characterization requirements, as well as a bottleneck in viral vector supply. The manufacturing processes and analytical tools for gene therapy viral vectors need ...
By Protheragen
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Pharmaceutical Companies Rely on Nitrogen
Pharmaceutical firms research, develop, and manufacture over-the-counter and prescription drugs and medicines. Usage of these drugs includes, but is not limited to, vaccinations, treatment for chronic conditions, and pain management. To protect the health and well-being of the public, the pharmaceutical industry is one of the most highly regulated industries. For instance, in the United States, ...
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Q&A with Dr. Veronica Iatarola Antas, Research Scientist and Project Lead at Regeneus
Q. Tell us about your role as a Research Scientist and Project Lead at Regeneus? A. My role is extremely diverse and has evolved over my time at Regeneus. Initially, I was responsible for optimising our product manufacturing processes, including manufacturing products for our preclinical and clinical trials. For example, I provided the data to support preclinical studies that evaluated ...
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Advice for EU GMP 5 μm Particle Limits
Abstract The EU GMP Annex 1 Guide requires continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle counting system, such as the Airnet II or IsoAir 310P. This is because the risk of contamination of finished product is very high and the greatest risk, the operator, is in close proximity. The operator is not only the greatest risk posed to product but also ...
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Electronic Data in Pharmaceutical Manufacturing: Secure Data Transfer (Series Part 3 of 6)
Secure Data Transfer Even small businesses with a single particle counter or other analyzer can benefit from the secure data transfer that a real-time online monitoring system provides. Real-time monitoring systems can, with great reliability, integrate data from several sources into a centralized and stable database. They remain secure while providing powerful analytical and reporting tools to ...
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Electronic Data in Pharmaceutical Manufacturing: Data Integrity (Series Part 1 of 6)
Data Integrity - Data Storage & Retrieval Data integrity means data that is accurate, complete and repeatable, which in turn ensures the product’s quality and public safety. Compliance is the goal of improving process control, product quality and Regulator confidence while reducing product defects and costs. Both of these concepts work hand-in-hand and apply to multiple areas of the ...
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Good Manufacturing Procedures - `GMP`.
I get excited every time I discover another use for safetytoes. Since I brought the ‘Slipp-R’ to market in 2006 I have been working hard to raise awareness for safetytoe overshoes. Often it’s the style and wear-ability factors that detract from good safety practices but also it’s just lack of awareness that puts visitors and others at risk where toe protection is sought. The ‘Slipp-R’ was ...
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Bioriginal – case study
Bioriginal Food and Science Corp. is a world leader in the production and distribution of high-quality, innovative Essential Fatty Acid (EFA) solutions including Omega-3, Omega-6 and Omega-9 ingredients from both marine and plant sources. Bioriginal began working with POS Bio-Sciences in the 1990s to develop its extraction and purification processes for novel oils. The result? Bioriginal Food ...
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