Lab Essentials for Quality Control’s Post

🔍 Spotlight on FDA Observations: Contamination/Aseptic Processing and Personnel 🔬 Three of the top ten areas with the most FDA observations are contamination, aseptic processing, and personnel. Key issues identified include: 📢 No Established Procedure: It is vital to have well-defined procedures to maintain aseptic conditions and ensure product safety. 📢 Inadequate Procedure: Procedures must be thorough and comprehensive to address all potential risks of contamination. 📢 Procedure Not Followed: Strict adherence to established protocols is crucial. Deviations can compromise the sterility and safety of the products. 📢 Inadequate or Missing Personnel Monitoring Data: Regular and precise monitoring of personnel involved in aseptic processes is necessary to prevent contamination. 📢 Lack of Controls Around Sterile Environments: Robust control measures must be in place to maintain the integrity of sterile environments. 🔬 Addressing these areas is not just about compliance but ensuring the highest standards of safety and efficacy in products. Let's commit to excellence in aseptic processing by: ✅ Establishing and continually refining comprehensive procedures. ✅ Ensuring strict adherence to protocols. ✅ Implementing rigorous personnel monitoring and training. ✅ Enhancing control measures around sterile environments. Together, we can meet and exceed regulatory expectations, safeguarding public health and maintaining trust in our industry. 🌟 I invite you to share your insights or questions on how to effectively address these challenges! 💬👇 #Pharmaceuticals #AsepticProcessing #QualitySystems #ContaminationControl #GMP 

🔍 Spotlight on FDA Observations: Contamination/Aseptic Processing and Personnel 🔬 Three of the top ten areas with the most FDA observations are contamination, aseptic processing, and personnel. Key issues identified include: 📢 No Established Procedure: It is vital to have well-defined procedures to maintain aseptic conditions and ensure product safety. 📢 Inadequate Procedure: Procedures must be thorough and comprehensive to address all potential risks of contamination. 📢 Procedure Not Followed: Strict adherence to established protocols is crucial. Deviations can compromise the sterility and safety of the products. 📢 Inadequate or Missing Personnel Monitoring Data: Regular and precise monitoring of personnel involved in aseptic processes is necessary to prevent contamination. 📢 Lack of Controls Around Sterile Environments: Robust control measures must be in place to maintain the integrity of sterile environments. 🔬 Addressing these areas is not just about compliance but ensuring the highest standards of safety and efficacy in products. Let's commit to excellence in aseptic processing by: ✅ Establishing and continually refining comprehensive procedures. ✅ Ensuring strict adherence to protocols. ✅ Implementing rigorous personnel monitoring and training. ✅ Enhancing control measures around sterile environments. Together, we can meet and exceed regulatory expectations, safeguarding public health and maintaining trust in our industry. 🌟 I invite you to share your insights or questions on how to effectively address these challenges! 💬👇 #Pharmaceuticals #AsepticProcessing #QualitySystems #ContaminationControl #GMP 

A contamination control strategy (CCS) is a system that considers all the integral elements of pharmaceutical product manufacturing. A CCS should cover: Microbial contamination Cleaning and disinfection Sterility assurance Facility design Chemical and particle contamination Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations The need for a CCS forms a core part of the revision to EU GMP Annex 1 however its easy to feel cautious when creating a CSS for the first time. In this blog we look at how developing the strategy might be approached, with due care taken in regards to how it is pieced together by the right personnel in possession of the relevant education, experience and technical knowledge. CPD

I'm happy to share that I have successfully completed a sequel to a comprehensive GMP course, it's annex 1 according to the EU (European Union) and it provided invaluable insights into maintaining sterility, contamination control, and compliance with industry regulations. Key Highlights: - Annex 1 Guidelines: Focused on sterile product manufacturing, providing regulatory guidance for sterilization, quality, and safety standards. - Quality Risk Management (QRM): Identifying, evaluating, and mitigating risks while ensuring continuous review and communication of potential hazards. - Consequences of Non-Compliance: Fines, product recalls, license revocation, and significant reputational damage in the EU market for failing to adhere to GMP. - Sterility Importance: Ensuring the absence of viable microbes in pharmaceutical products to prevent harmful infections, particularly in critical formulations like parenterals, ophthalmics, and wound irrigation solutions. - Sterilization Methods: - Terminal Sterilization: Preferred method using lethal conditions to achieve a sterility assurance level (SAL) of ≤ 10⁻⁶. - Aseptic Processing: Ensures sterile product handling in controlled environments with strict contamination controls. - Contamination Control Strategies: Implementation of Pharmaceutical Quality Systems (PQS) and Contamination Control Strategies (CCS) to mitigate contamination risks across the product lifecycle. This certification strengthens my commitment to upholding high safety standards in pharmaceutical manufacturing and ensures compliance with global regulations to protect patient health. #GMP #PharmaceuticalSafety #SterilityAssurance #QualityControl #RiskManagement #RegulatoryCompliance #ProfessionalDevelopment #PharmaIndustry

Before disinfection, it’s important to remove stubborn contaminants. That’s where our low-foaming Sterile Alkaline Detergent comes in. 🧽 Effectively removes visible soiling and residue build-up 🫧 Has pH12 which is ideal for deep cleans and high-protein load cleaning 🧼 Does not leave significant residues 💧 Made with WFI water ✅ Quality Management Certified to BS EN ISO 9001:2015 📋 Manufactured in accordance with the cGMP Guidelines Our Sterile Alkaline Detergent range is available in 1L and 5L cap bottles, and 900ml trigger bottles 👉 https://hubs.ly/Q02NlTH_0 #Pharmaceuticals #Cleanrooms #Disinfection #SterileProcessing #QualityControl #GMP #ISO9001 #Healthcare #Annex1

Good Manufacturing Practice (GMP) is a set of rules that ensure high standards of quality💎 and safety in pharmaceutical production. GMP emphasizes ✅hygiene, ✅quality, ✅consistency, ✅transparency and ✅repeatability of processes. In the world of pharmacy, quality and safety are priorities. That's why the GMP certificate is so important. We are proud to highlight that each of our three manufacturing sites has received the GMP certificate issued by the Chief Pharmaceutical Inspector.👏 But what does this really mean for our customers? 🤔 ➡️Precise process control ensures the highest level of safety. Every production stage is thoroughly documented 📋and followed according to required procedures. This guarantees that products are manufactured with the highest precision, eliminating the risk of errors and ensuring consistent quality. ➡️By strictly adhering to hygiene principles and technical equipment control, our production processes minimize the risk of contamination. Customers can be confident that their products are manufactured in hygienic conditions. ➡️Safety. Each raw material and intermediate product is carefully checked🔍 and identified before use. This ensures that only verified materials are used in the production process, enhancing the quality of the final product. ➡️Documentation and transparency of production. All process parameters are meticulously recorded, allowing for complete openness, transparency, and traceability of every production stage. ➡️Employees are responsible for their actions and are obligated to report any irregularities immediately. This enables quick response and correction of potential errors, ensuring that the final products meet the highest quality and safety standards. By choosing Prespack, customers gain the assurance that their products are manufactured with the utmost care for quality and safety. Take advantage of professional contract packaging services.💊👌 #GMP #pharmacy #quality #safety #contractmanufacturing #certificates #serialization #pharma #prespackteam

⭐ ⭐ Contamination Control Training: A Must for Pharmaceutical Manufacturing! ⭐ ⭐ In the pharmaceutical industry, contamination control isn’t just a priority—it’s a necessity. Maintaining sterile environments is crucial for product quality and patient safety. 💊 💉 That’s why effective training on contamination control strategies is vital for every employee involved in the production process which further ensures full compliance with regulatory standards. Some of the training required are: 1️⃣ Cleanroom Protocol Training - cleanroom behavior, and environmental monitoring. 2️⃣ Sterile Technique Mastery – to prevent microbial contamination 3️⃣ Regular Disinfection Procedures – with effective disinfection methods and the correct use of approved cleaning agents. 4️⃣ Air Quality & HEPA Filtration – to reduce airborne contaminants. 5️⃣ Continuous Monitoring & Audits – monitor and perform routine audits to ensure compliance with GMP (Good Manufacturing Practices) standards. Protect your products, patients, and reputation with robust, ongoing contamination control training. Register now for our upcoming training workshop to avoid disappointment. Email: info@cstvalconsulting.co.za Call +27 72 613 1947 or +27 68 143 2359 #PharmaTraining #ContaminationControl #GMPCompliance #SterileManufacturing #PharmaSafety #ContinuousImprovement

What's your Contamination Control Strategy (CCS)? Meeting the stringent requirements of the EU GMP Annex 1 can be a significant challenge. Reducing particle contamination is crucial for maintaining the highest standards in sterile medicinal product manufacturing. The updated EU GMP Annex 1 places a strong emphasis on environmental and process monitoring for both viable and non-viable particles. It mandates that risk assessments be thorough and scientifically justified, ensuring quality control through comprehensive monitoring systems and a robust Contamination Control Strategy (CCS). This strategy must be an active, evolving document, continuously updated to reflect the latest risk assessments and monitoring results. To help navigate these requirements, SCHOTT Pharma offers an insightful guide on the five essential steps for reducing particle contamination in RTU packaging. This blog post from my colleague Robert Lindner is a must-read for anyone looking to comply with the stringent EU standards and ensure the safety and efficacy of their products. Check out the full article here: https://lnkd.in/esRqM76W "5 Steps for Particle Reduction in RTU Packaging" and download the whitepaper. #SCHOTTpharma #adaptiQ #RtU

🚨 It's Warning Letter Wednesday🚨 ... This time we focus on a US based manufacturer issued a Warning Letter on 21 May... Violations include: 1️⃣ Inadequate Cleaning and Maintenance Procedures - The company used the same equipment for manufacturing drugs and industrial chemicals without proper cleaning validation, risking cross-contamination. 💡Corrective Actions: - Conduct a thorough review of cleaning effectiveness for all equipment used for multiple products. - Implement a CAPA plan to improve facility and equipment management, ensuring prompt detection and repair of issues. - Develop a detailed plan to enhance cleaning procedures, including regular validation and verification. 2️⃣ Inadequate Investigation of Batch Failures - The company failed to properly investigate and document out-of-specification (OOS) results, leading to unreliable data and compromised product quality. 💡Corrective Actions: - Review and improve documentation systems to ensure complete and accurate record-keeping. - Conduct a retrospective review of all invalidated OOS results from the past three years and identify root causes. 3️⃣ Lack of Identity Testing for Drug Components - The company did not test incoming components like ethanol and glycerin for identity and purity, accepting incomplete certificates of analysis from suppliers. 💡Corrective Actions: - Commit to testing each lot of components for identity, strength, quality, and purity before use. - Review and qualify all suppliers and establish appropriate testing intervals. - Develop a program to qualify and oversee contract facilities that test drug components. 4️⃣ Inadequate Quality Control Unit (QU) - The QU did not have the authority or resources to ensure compliance with CGMP, lacking essential manufacturing records and procedures. 💡Corrective Actions: - Assess and improve the QU's authority and resources to ensure effective operation. - Ensure robust procedures and oversight for all manufacturing processes. - Implement a plan for ongoing management oversight to maintain compliance with quality standards throughout the product lifecycle. 💡Immediate Steps to be taken: ✅Provide the FDA with a detailed plan addressing each violation. ✅Ensure ongoing compliance with CGMP by improving cleaning, investigation, testing, and quality control procedures. ✅Clarify future manufacturing plans and ensure all deficiencies are resolved before resuming operations. These steps will help the company to meet FDA standards and produce safe, high-quality drug products. Thanks for reading!

The revised EDQM guideline “content of the dossier”. The revised version of the EDQM guideline The Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of *1st May 2024* . This guideline and other key documents (QOS, top ten deficiencies), as well as the use of *EMA SPOR/OMS ORG_ID and LOC_ID* are essential to avoid a CEP dossier being *blocked* at receipt or receiving requests for additional information. Changes introduced in this revised guideline aimed to align requirements with the current regulatory environment (since the previous version of this document was implemented in January 2019). In particular, the guideline has been updated for below. In Module 1, particular attention should be paid to use the appropriate _EMA SPOR/OMS ORG_ID and LOC_ID_ for the *CEP holder and* *manufacturing sites* , and the declarations given in annex of the application form should be duly filled in. The Module 2 is the Quality Overall Summary (QOS) for which an updated template is now available. It serves as a concise overview of Module 3, highlighting the control strategy applied and how regulatory requirements are met to ensure the quality of the substance, and providing assessors with a clear understanding of the substance’s specification and manufacturing process. The QOS is a mandatory component of the CEP application and should be treated with utmost importance and consistency with Module 3. A *poorly crafted* or *incomplete QOS* can hinder the assessment process and *lead to delays* , potentially jeopardising the overall timelines to obtain a CEP. The updates concerning the *Module 3* include for example new *requirements for CEP 2.0,* encouragement to *apply for a re-test period* with possibility to refer to *all ICH climatic zones* and introduction of Post-Approval Change Management Protocol(s). Other notable changes include amongst others, *detailed expectations* for sections related to the *manufacturing process, starting materials and* *intermediates* facilitating the understanding of the control strategy proposed. The need to build a comprehensive *risk assessment based on ICH M7* and taking also into account the *potential risk for formation and carry-over of nitrosamines* has been added. Changes regarding submission of applications for sterile active substance are mentioned but will be covered by specific EDQM guidance. The EDQM document “Top ten deficiencies in New Applications for Certificates of Suitability for chemical purity” (Shared in my earlier post) helps also applicants to avoid deficiencies by giving expanded details on specific points of Module 3. To enable an efficient treatment of CEP applications the EDQM will implement a *stricter validation of applications* *at receipt* Refer enclosed document for brief.