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Here are some tips for microbiological control of anticancer drugs and validations: 1. Strict Sterility Testing: Ensure that all components of the anticancer drug formulation, including raw materials, excipients, and final products, undergo rigorous sterility testing to detect and prevent microbial contamination. 2. Use of Antimicrobial Preservatives: Incorporate antimicrobial preservatives into formulations where appropriate, especially for multi-dose vials or products prone to microbial growth during use. 3. Validation Studies: Conduct comprehensive validation studies to assess the effectiveness of microbiological control measures. This may include studies on sterilization processes, aseptic filling, environmental monitoring, and stability testing. 4. Environmental Monitoring: Implement a robust environmental monitoring program to regularly assess the microbial bioburden in manufacturing facilities and cleanrooms. This helps identify potential sources of contamination and allows for timely corrective actions. 5. Good Manufacturing Practices (GMP): Adhere strictly to GMP guidelines throughout the manufacturing process to minimize the risk of microbial contamination. This includes maintaining clean and controlled environments, proper personnel hygiene, and equipment sanitation. 6. Regular Audits and Inspections: Conduct regular audits and inspections of manufacturing facilities by internal and external quality assurance teams to ensure compliance with regulatory requirements and industry standards for microbiological control. 7. Continuous Improvement: Foster a culture of continuous improvement by analyzing microbiological data, investigating deviations, and implementing corrective and preventive actions to enhance the effectiveness of microbiological control measures over time. By following these tips, pharmaceutical companies can maintain the microbiological quality of anticancer drugs and ensure the safety and efficacy of these life-saving medications.

Microbiological Quality Control of PharmaceuticalProducts....... Contamination of pharmaceutical products by objectionable microorganisms is a major risk within the pharmaceutical industry as it may impact product integrity and patient safety. To prevent contamination events from occurring, licensed pharmaceutical manufacturing companies worldwide are required to adhere to strict regulations and robust quality control procedures issued by their respective government agencies. These regulatory processes and procedures comprise various quality control methods, such as those described in the United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP). When properly followed, these procedures can help identify microbial contamination prior to product release, thus avoiding the pitfalls of product recalls. Microbiological quality control is an essential part of the pharmaceutical manufacturing process. Pharmaceutical companies must safeguard the quality and safety of their products by thoroughly testing raw materials, equipment, environmental surfaces, and final preparations for microbial contaminants that may have been introduced inadvertently during or subsequent to the manufacturing process. Currently, there are a number of microbiological quality control assays recommended, including growth promotion testing, microbial enumeration testing, and antimicrobial effectiveness testing. Growth promotion testing, for example, is a common quality control assay used to establish the nutritional properties of culture media to ensure that microbial growth can be supported. This form of testing is important because culture media is frequently employed in various pharmacopeial quality control assays. If a batch of media is found to be unable to support microbial growth, the results of all assays for which the media was intended will be unreliable, and the pharmacopeial tests will fail. Following growth promotion testing of culture media, approved batches of media can be used in other quality control assays such as the microbial enumeration test (USP <61>) or the antimicrobial effectiveness test (USP <51>).1,2 These particular tests are designed to determine whether a pharmaceutical product complies with an established specification for microbiological quality or demonstrates effective antimicrobial protection, respectively. In particular, the microbial enumeration test is recommended to ensure that the product contains less than the allowable concentration of an objectionable organism via direct plating, membrane filtration, or the most-probable-number method. In contrast, the antimicrobial effectiveness test is performed to confirm that the antimicrobial preservatives added to the final product are demonstrating an effective level of microbial growth inhibition. Further, each strain is maintained and handled using procedures recommended by USP Chapter <1117>,

What is role of HEPA filter in Pharmaceutical Plants?   HEPA (High Efficiency Particulate Air) filters play a crucial role in maintaining clean and controlled environments in pharmaceutical plants. These filters are designed to capture and remove airborne particles and contaminants, including dust, microbes, and other particulates, with a high efficiency rate. Here are some key roles of HEPA filters in pharmaceutical plants: 1. Contamination Control: HEPA filters help control contamination by removing airborne particles and microorganisms from the air within critical areas of pharmaceutical plants, such as cleanrooms, sterile manufacturing areas, and laboratories. By effectively capturing contaminants, HEPA filters help prevent product contamination and ensure the quality and integrity of pharmaceutical products. 2. Cleanroom Classification: HEPA filters are essential components of cleanroom systems used in pharmaceutical manufacturing facilities. Cleanrooms are classified based on the concentration of airborne particles allowed within the controlled environment. HEPA filters contribute to achieving and maintaining the required cleanliness levels by removing particles as small as 0.3 microns with an efficiency of 99.97% or higher. 3. Compliance with Regulatory Standards: Pharmaceutical plants are subject to strict regulatory requirements, including Good Manufacturing Practices (GMP) and other industry guidelines, which mandate the use of appropriate air filtration systems to maintain clean and controlled environments. HEPA filters help pharmaceutical plants comply with these regulatory standards by providing effective air filtration and contamination control measures. 4. Protection of Personnel: HEPA filters contribute to protecting personnel working in pharmaceutical plants by minimizing their exposure to airborne contaminants and particulates. By maintaining clean air environments, HEPA filters help reduce the risk of respiratory problems, allergies, and other health issues among plant personnel. 5. Product Quality Assurance: The use of HEPA filters in pharmaceutical plants helps ensure the quality and purity of pharmaceutical products by preventing airborne contamination during manufacturing, packaging, and storage processes. HEPA-filtered air is used in critical areas where product integrity is paramount, such as aseptic processing areas and sterile filling lines. 6. Environmental Monitoring: HEPA filters are essential components of environmental monitoring systems used to assess and maintain air quality within pharmaceutical plants. These filters are monitored and tested regularly to ensure their effectiveness in removing airborne contaminants and maintaining clean air environments. O          

𝘄𝗵𝗮𝘁'𝘀 𝘁𝗵𝗲 𝗺𝗮𝗶𝗻 𝘁𝗲𝘀𝘁𝘀 𝗶𝗻 𝗺𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗶𝗻 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 ?🤔🧐 - **🔮Growth promotion testing**: 📝This test is used to establish the nutritional properties of culture media to ensure that microbial growth can be supported. - **🔮Microbial enumeration testing**: 📝This test is used to determine whether a pharmaceutical product complies with an established specification for microbiological quality by counting the number of viable microorganisms in the product. - **🔮Antimicrobial effectiveness testing**: 📝This test is used to confirm that the antimicrobial preservatives added to the final product are demonstrating an effective level of microbial growth inhibition. - **🔮Sterility testing**: 📝This test is used to verify that a product is free from viable microorganisms that could cause infection or spoilage. - **🔮Bacterial endotoxin testing**: 📝This test is used to detect and quantify the presence of pyrogens, which are fever-inducing substances produced by some bacteria, in a product. - **🔮Particulate matter testing**: 📝This test is used to measure the amount and size of particles in a product, which could affect its quality, safety and efficacy. - **🔮Device bioburden testing**: 📝This test is used to determine the number and types of microorganisms on a medical device before sterilization. - **🔮Environmental monitoring testing**: 📝This test is used to assess the microbiological quality of the environment where the pharmaceutical products are manufactured, stored and distributed. #microbiology #QC #pharmaceutical #bacteria #fungi #USP #Food

Welcome to the Certificate Course in Pharmaceutical Microbiology! Are you ready to delve into the fascinating world of pharmaceutical microbiology? This comprehensive course is designed to provide you with the essential knowledge and practical skills needed to excel in microbiological testing and quality control within the pharmaceutical industry. Throughout this course, you will explore a wide range of topics, including: Introduction to Pharmaceutical Microbiology: Gain a foundational understanding of microbiology's role in the pharmaceutical industry and its importance in ensuring product quality and safety. Flow of Microbiology Laboratory and Facility Design: Learn about the layout and design considerations of microbiology laboratories to facilitate efficient workflow and maintain sterile environments. Media Receipt, Storage, Preparation: Understand the critical steps involved in handling microbiological media, from receipt and storage to preparation for testing. Microbial Growth Promotion Test and Qualification: Discover techniques for evaluating the performance of microbiological media to ensure accurate microbial growth. Culture Handling: Master the techniques for handling and manipulating microbial cultures safely and effectively. Types of Water Systems in Pharma Industry, Validation Overview: Explore the various types of water systems used in pharmaceutical manufacturing and the validation processes involved. Water Sampling, Testing, and Data Trending: Learn the procedures for sampling and testing pharmaceutical water systems and how to analyze and interpret the data for trend analysis. Types of Environmental Monitoring and Data Trending: Understand the importance of environmental monitoring in pharmaceutical facilities and techniques for data trending to ensure compliance with regulatory standards. Environmental Monitoring Location Selection Criteria and Risk Assessments: Explore the factors influencing the selection of environmental monitoring locations and conduct risk assessments to identify potential microbiological hazards. Microbial Limit Test: Learn about microbial limit testing methods and regulatory requirements for assessing microbial contamination in pharmaceutical products. Bacterial Endotoxin Test: Understand the principles and procedures of bacterial endotoxin testing to ensure the safety of pharmaceutical products. Sterility Testing: Discover the methods and validation processes for sterility testing to confirm the absence of viable microorganisms in pharmaceutical products. And much more! By enrolling in this course, you will gain practical insights, valuable skills, and industry-recognized certification to advance your career in pharmaceutical microbiology. Don't miss this opportunity to become a proficient and knowledgeable professional in the field of pharmaceutical quality control. Enroll now and embark on your journey to mastering pharmaceutical microbiology! https://lnkd.in/ddY6zQPa

‼️USP MICROBIOLOGY NEW‼️ Proposed Compendial Approach for the Implementation of <60> Microbiological Examination of Nonsterile Products ̶ Tests for Burkholderia Cepacia Complex (BCC) Suggested Audience: #Suppliers and #manufacturers of #drugsubstances, #pharmaceuticalmanufacturers, #contractmanufacturing and #testingorganizations, #regulatoryagencies, and QA/QC specialists. 💠 Background and Objective The #USP is dedicated to ensuring the highest level of #microbiologicalquality in #nonsterilepharmaceuticalproducts. As part of this commitment, we are proposing a new compendial approach for the implementation of <60> Microbiological Examination of Nonsterile Products ̶Tests for #BurkholderiaCepaciaComplex (#BCC). A critical aspect of pharmaceutical quality is the mitigation of risks associated with #microbiologicalcontamination. ‼️BCC represents a significant concern due to its ability to survive in various environments and its association with serious adverse events. The FDA has highlighted the importance of robust testing for BCC in aqueous non-sterile products. ➡️ Proposed Compendial Approach: This approach emphasizes the inclusion of essential local text within harmonized chapters, ensuring the applicability of BCC tests to products for inhalation use or aqueous preparations for oral, oromucosal, cutaneous, or nasal use. ➡️ The proposed updates highlight the importance of ensuring that certain dosage forms are free from BCC to protect #patientsafety and #productintegrity. ➡️ The approach consists of the following steps: ✅ Revise the General Chapter <62> Tests for Specified Microorganisms to include a requirement that products with a water activity of 0.6 or higher must be tested to demonstrate the absence of BCC as directed in General Chapter <60>. This will provide clearer guidance on when BCC testing is required. ✅ Update the following relevant Informational General Chapters: a. Align <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use to reflect these requirements, ensuring that the application of BCC tests is addressed uniformly. b. Revise <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products for consistency. ✅ PDG Collaboration: Work in close coordination with the Pharmaceutical Discussion Group (PDG) to harmonize standards on a global scale. Initially, the USP intends to include local text to <62> and <1111>. ✅ Update monographs: Review and revise monographs as necessary. USP is considering direct references to GC <60> for higher-risk products. 💠 Preliminary Examples of Proposed Revisions: The following examples (picture) include the proposed wording intended for inclusion in <62> Tests for Specified Microorganisms and potential revisions to Table 1 in <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. If you like this post follow me on LinkedIn

#Proposed #Compendial Approach for the Implementation of <60> Microbiological Examination of Nonsterile Products ̶ Tests for #Burkholderia #Cepacia #Complex (#BCC) Type of Posting: General Announcement Posting Date: 29-Mar-2024 Input Deadline: 27-Jun-2024 Expert Committee: General Chapters – Microbiology #Suggested #Audience: Suppliers and manufacturers of drug substances, pharmaceutical manufacturers, contract manufacturing and testing organizations, regulatory agencies, and QA/QC specialists. #Background and #Objective: The United States Pharmacopeia (USP) is dedicated to ensuring the highest level of microbiological quality in nonsterile pharmaceutical products. As part of this commitment, we are proposing a new compendial approach for the implementation of <60> Microbiological Examination of Nonsterile Products ̶Tests for Burkholderia Cepacia Complex (BCC). A critical aspect of pharmaceutical quality is the mitigation of risks associated with microbiological contamination. BCC represents a significant concern due to its ability to survive in various environments and its association with serious adverse events. The FDA has highlighted the importance of robust testing for BCC in aqueous non-sterile products1. In order to strengthen our collective defense against such risks, the USP is planning to revise several General Chapters to clarify the application of this test. Proposed Compendial Approach: This approach emphasizes the inclusion of essential local text within harmonized chapters, ensuring the applicability of BCC tests to products for inhalation use or aqueous preparations for oral, oromucosal, cutaneous, or nasal use. The proposed updates highlight the importance of ensuring that certain dosage forms are free from BCC to protect patient safety and product integrity. USP is sharing the proposed plan towards a holistic framework for microbiological testing for Burkholderia cepacia complex. The approach consists of the following steps: Revise the General Chapter <62> Tests for Specified Microorganisms to include a requirement that products with a water activity of 0.6 or higher must be tested to demonstrate the absence of BCC as directed in General Chapter <60>. This will provide clearer guidance on when BCC testing is required. Update the following relevant Informational General Chapters: a. Align <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use to reflect these requirements, ensuring that the application of BCC tests is addressed uniformly. b. Revise <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products for consistency. PDG Collaboration: Work in close coordination with the Pharmaceutical Discussion Group (PDG) to harmonize standards on a global scale. Initially, the USP intends to include local text to <62> and <1111>. Update monographs: Review and revise monographs as necessary.

𝘄𝗵𝗮𝘁'𝘀 𝘁𝗵𝗲 𝗺𝗮𝗶𝗻 𝘁𝗲𝘀𝘁𝘀 𝗶𝗻 𝗺𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗶𝗻 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 ?🤔🧐 - **🔮Growth promotion testing**: 📝This test is used to establish the nutritional properties of culture media to ensure that microbial growth can be supported. - **🔮Microbial enumeration testing**: 📝This test is used to determine whether a pharmaceutical product complies with an established specification for microbiological quality by counting the number of viable microorganisms in the product. - **🔮Antimicrobial effectiveness testing**: 📝This test is used to confirm that the antimicrobial preservatives added to the final product are demonstrating an effective level of microbial growth inhibition. - **🔮Sterility testing**: 📝This test is used to verify that a product is free from viable microorganisms that could cause infection or spoilage. - **🔮Bacterial endotoxin testing**: 📝This test is used to detect and quantify the presence of pyrogens, which are fever-inducing substances produced by some bacteria, in a product. - **🔮Particulate matter testing**: 📝This test is used to measure the amount and size of particles in a product, which could affect its quality, safety and efficacy. - **🔮Device bioburden testing**: 📝This test is used to determine the number and types of microorganisms on a medical device before sterilization. - **🔮Environmental monitoring testing**: 📝This test is used to assess the microbiological quality of the environment where the pharmaceutical products are manufactured, stored and distributed. #microbiology #QC #pharmaceutical #bacteria #fungi #USP #Food

Thanks to USP for considering BCC testing as Mandatory testing and added in Chapter USP <1111>.. And not only that USP also gives emphasis for testing Water Activity of products to check is the aw 0.6 or greater.. This organism can resist Against Conventional preservative system specially in non sterile product. And the preservative system can not suppress this organism.. So it is a great initiative by USP...

Pharmaceutical Validation explained through the "Great British Bake Off!" You know the term "pharmaceutical validation" but maybe you are not sure what it really means. Let's explore the area of validation but, we’re going to think about the concepts as if we were baking a batch of cakes. I know it seems different but keep reading and it'll begin to make sense. BTW, here is the link to the full article https://lnkd.in/g_HDKhzc At its most simple – validation is testing whether something works, as well as writing down what you did and what happened when you did it. This means you can prove that it worked to others who weren’t there. There are many other definitions of validation but the essence of all these definitions seems to be “documented scientific proof of consistent performance“. So imagine we’re baking our batch of cakes… Validation is like following the world’s most in-depth recipe. We don’t just test the final cake – we test things throughout the baking process, write down the results and compare them against what the recipe says they should be. Perhaps we’re testing the temperature of the oven, the runniness of our cake mixture, or the speed of the mixer. If each of these tests (and many more) match with what the recipe tells us to expect, the cakes at the end are much more likely to turn out the way we want. So we have to follow the detailed recipe, whether we have years of experience or it's our first time baking. We want a delicious cake at the end, that tastes exactly like we expect it to. But more than that, we also need to be sure it’s not going to give us food poisoning. Now imagine you are inside a pharmaceutical manufacturing plant. We can test final medicines at the end of the production process but final end-product testing just isn’t enough. Every time you test medicines you have less to give to patients. If you are just testing quality through final products, you have to test a lot of them. However, if you can confirm that a medicine is safe to use every time you made it a certain way AND that you made it the same way every time, it’s a reasonable assumption that the medicine you made this time (in the same way) is also safe for patients to use. This is what happens when you use a “validated process” to make the medicines. Here is the link again https://lnkd.in/g_HDKhzc If you'd like to learn more about our AWARD-WINNING pharmaceutical and validation courses, visit https://lnkd.in/gsiJ-Zbe ☎️ Or feel free to reach out. Our team includes engineers, scientists, and lab technicians who have worked in the pharma industry. You are welcome to pick our brains on the types and range of jobs in the pharmaceutical manufacturing sector. #pharmaceuticalvalidation #computersystemvalidation #riskmanagement #pharmaceuticalmanufacturing #pharmajobs #getreskilled #validation #pharmaindustry #pharmaceutical