NutraStar’s Post

𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠 𝐢𝐧 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐢𝐞𝐬 plays a crucial role in quality assurance, regulatory compliance, and patient safety. By implementing robust sampling protocols and quality control measures etc. 𝐑𝐚𝐰 𝐌𝐚𝐭𝐞𝐫𝐢𝐚𝐥 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠: Raw materials, including active pharmaceutical ingredients (APIs), excipients, and packaging materials, undergo sampling to verify their identity, purity, and quality before use in manufacturing. Sampling methods such as random sampling and stratified sampling may be employed to ensure representative samples are obtained. 🧪 𝐈𝐧-𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠: During drug manufacturing, in-process sampling involves collecting samples at different stages of production to monitor critical process parameters (CPPs) and ensure product quality and consistency. In-process samples are tested for attributes such as potency, purity, uniformity, and dissolution rate. 🏭 𝐅𝐢𝐧𝐢𝐬𝐡𝐞𝐝 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠: Finished product sampling is conducted to assess the quality, safety, and efficacy of pharmaceutical products before release to the market. Samples are collected from batches for testing against predefined specifications, including identity, strength, purity, stability, and microbiological attributes. 📦 𝐄𝐧𝐯𝐢𝐫𝐨𝐧𝐦𝐞𝐧𝐭𝐚𝐥 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠: Sampling of the manufacturing environment, including air, surfaces, and water systems, is essential to assess the cleanliness, microbial contamination, and compliance with Good 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 (𝐆𝐌𝐏): Environmental monitoring helps prevent cross-contamination and ensure product safety. 🌿 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠:Quality control (QC) sampling involves routine testing of samples from different stages of manufacturing and storage to verify compliance with regulatory requirements and internal quality standards. Analytical techniques such as chromatography, spectroscopy, and microbiological assays are used for QC testing. 🔍 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠 𝐏𝐥𝐚𝐧𝐬 𝐚𝐧𝐝 𝐏𝐫𝐨𝐜𝐞𝐝𝐮𝐫𝐞𝐬: Pharmaceutical companies develop sampling plans and procedures based on regulatory guidelines, pharmacopeial standards, and internal quality systems. Sampling plans define sample sizes, sampling frequencies, acceptance criteria, and documentation requirements to ensure consistent and reliable sampling practices. 📝 𝐆𝐨𝐨𝐝 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 (𝐆𝐒𝐏): GSP encompass a set of principles and best practices for sampling in pharmaceutical industries to ensure the integrity, representativeness, and traceability of samples. GSP guidelines emphasize proper sample collection, handling, labeling, storage, and documentation to minimize errors and contamination risks. ✅ #PharmaceuticalIndustry #QualityControl #Manufacturing #SamplingTechniques #GoodManufacturingPractices #LinkedInPost

We are pleased to share Tamer Helmy, PhD's insights on the crucial role of quality culture in the pharmaceutical industry post-pandemic. Tamer is one of our Quality Consulting Partners for QxP, and his article on the PDA - Parenteral Drug Association website underscores the significance of robust quality management systems and strong leadership in ensuring patient safety and continuous improvement. At Quality Executive Partners (QxP) we are dedicated to upholding these principles to drive excellence in our industry. Read the full article by clicking on the image below. #pharma #biotech #qualityassurance

My latest article published in #PDA Letter. "Quality Culture Post Pandemic." Let me know what you think… #qualityculture #pharmaceutical #pharmaceuticalindustry #pharmaceuticals #qualityassurance #qualitymanagementsystem #quality #qualitymanagement #qms

🅷🅰🅿🅿🆈 🅻🅴🅰🆁🅽🅸🅽🅶 👉🏽𝗛𝗼𝘄 𝘁𝗼 𝘀𝗲𝘁 𝘁𝗵𝗲 𝗣𝗗𝗘 𝗹𝗶𝗺𝗶𝘁𝘀 𝗳𝗼𝗿 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗰𝗿𝗼𝘀𝘀-𝗰𝗼𝗻𝘁𝗮𝗺𝗶𝗻𝗮𝗻𝘁𝘀 𝗶𝗻 𝘀𝘂𝗯𝘀𝗲𝗾𝘂𝗲𝗻𝘁 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀?➡️ 𝗘𝗠𝗔 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 💊The process of establishing limits for potential cross-contaminants in subsequent products is a fundamental aspect of cleaning validation. The traditional criteria of 1/1000 dose and 10 ppm, while once prevalent, are now obsolete due to amendments in GMP regulations. 💊The acceptance criterion of "visibly clean" is no longer deemed sufficient; instead, it has been replaced by the science-based Permitted Daily Exposure (PDE) limit. This limit is derived from scientific data, including toxicological studies, and involves risk assessment. ⚡️The comprehensive cleaning validation process involves multiple steps: ❇️Deriving a health-based limit (PDE) for cross-contaminants, encompassing residues of active substances, detergents, and potential degradation products. ❇️Validating the purification of specific starting materials, with their limits and purification success assessment being distinct from this process. ❇️Incorporating principles from the "EMA PDE Guideline" for determining PDE values across all active substances and cleaning agents, regardless of toxicity levels. ❇️Considering risk-based selection of other starting materials, such as odour- or colour-intensive excipients, for hygienic or visual reasons, even though they are not explicitly mentioned in the EU GMP Guidelines. 💊The "EMA PDE Guideline" provides flexibility in determining threshold values as long as they are scientifically justified. Occupational Exposure-Banding or the Threshold of Toxicological Concern (TTC) concepts are permissible alternatives for deriving these limits. 💊The core components of the cleaning validation process include identifying critical substances, calculating maximum safe carryover (MSC), pinpointing critical equipment sampling points, conducting residue analysis, and drawing overall conclusions about the equipment's effectiveness. Collaborative interdisciplinary teams, led by a validation coordinator, play a key role in executing cleaning validation projects, ensuring comprehensive expertise is leveraged. 💊Cleaning validation is paramount for product contact surfaces, while non-contact parts must also be considered. Preclinical development does not warrant validation, but cleaning success is verified through visual inspection and swab tests. 💊Validation scope for investigational medicinal products is risk-based. Ultimately, the PDE value signifies a substance's property, which may evolve based on new data. The cleaning validation process significantly contributes to quality assurance and compliance. Dr. Pari Subash Source: EMA #pharma #pharmaceutical #pharmaceuticalindustry #cleaning #pde

key concepts of Modern Quality System. 1. Quality : Every pharmaceutical product has established identity, strength, purity safety and effectiveness.which leads to quality product. 2. Quality by design and Product Development : It means designing and developing a product and its associated manufacturing operations that will be used during product development to ensure that the product consistently achieve a predefined quality at the end of manufacturing process. 3. Quality Risk Management: It is a important component of an effective quality system framework.It help in guide the setting of specifications and process parameters for drug manufacturing i.e. API (Active Pharmaceutical Ingredient) and drug product , assess and mitigate the risk related to changing a process or specification. 4. CAPA ( Corrective action and preventive action): It focuses on investigating, understanding and correcting discrepancies while attempting to prevent their recurrence. And preventive action to avert recurrence of a similar potential problem. 5. Change Control: It mainly focuses on managing change to prevent unintended consequence. changes like specification revision, process parameters and procedures etc. are handled through change control. 6. Quality unit: It contains both Quality assurance (QA) and Quality unit (QC). It ensure various operations associated with the modern quality system are appropriately planned , approved, executed and monitored. To ensure quality product, Quality should be built into the product and testing alone cannot be relied on to ensure product quality.

🏆 #Cleaning_Validation #1🏆 #Cleaning Objectives❗❗ Why do #pharmaceutical facilities want to clean❓ 🎯 To protect product #integrity 🎯 To reuse the #equipment 🎯 Because of #regulatory authorities’ requirement   ✨  PRODUCT INTEGRITY 📚Maintaining product integrity first includes preventing #cross_contamination, in which one drug #active from the product just cleaned becomes an unacceptable #contaminant in the next drug product “with a different active” manufactured in the cleaned equipment. Several issues arise here. 1️⃣ The possible #pharmacological effect of the contaminating #residue in the subsequently manufactured #product. 2️⃣ Possible #drug interactions between the contaminating drug active and the intended drug active in the contaminated product.   📚 Another issue in product integrity involves contamination not necessarily with another drug active but with drug #excipients, #cleaning_agents, and/or #equipment_residues (such as rouge and particulates from equipment wear). 📚 The third issue in product integrity involves #microbial and/or #endotoxin contamination, Clearly, this can present safety concerns, especially with parenteral products.   ✨  Special case of product integrity To maintain #lot_integrity on a dedicated product line or in a product campaign. ✔️ #Cleaning between lots of the same product is done for several reasons. 1️⃣ It may be required for proper equipment #function. 💡 For example, the buildup of residues may interfere with proper #tablet formation. 2️⃣ The second reason is to maintain lot integrity. 💡 If residues of the previous lot are not adequately removed, it may be difficult to maintain lot or batch integrity. Failure to maintain lot integrity may be a #significant issue if any one lot in a #campaign is involved in a potential #recall.   ✨  EQUIPMENT REUSE. 📚 If all #pharmaceuticalmanufacturing equipment were disposable, cleaning and #cleaning_validation would be of little concern; #imagine a future scenario in which all manufacturing equipment is disposable: After manufacturing a pharmaceutical product, the equipment is #crushed and sent to an incinerator for disposal. 👇 For most equipment today, this ideal situation is #rare; Most manufacturing equipment is #stainless_steel or #glass_lined and is relatively #expensive. 👇 High #capital costs require that the equipment be reused. 👇 Such equipment should be adequately #cleaned (at least the product contact surfaces) in a validated process. #quality #validation #pharmaceutical #contamination #drug #productdevelopment #pharmaceuticalindustry #qualification #cleanroom #cleanliness #pharma #manufacturing #environment #design #cleaningvalidation #processdevelopment #qbd #processvalidation #pharmaceuticalengineering #pharmaceuticalmanufacturing #qualityassurance

𝙒𝙝𝙖𝙩'𝙨 𝙩𝙝𝙚 𝙗𝙚𝙨𝙩 𝙨𝙤𝙪𝙧𝙘𝙚𝙨 𝙛𝙤𝙧 𝙤𝙗𝙩𝙖𝙞𝙣𝙞𝙣𝙜 𝙞𝙣𝙛𝙤𝙧𝙢𝙖𝙩𝙞𝙤𝙣 𝙞𝙣 𝙢𝙞𝙘𝙧𝙤𝙗𝙞𝙤𝙡𝙤𝙜𝙮 𝙦𝙪𝙖𝙡𝙞𝙩𝙮 𝙘𝙤𝙣𝙩𝙧𝙤𝙡?🤔 📝Best sources for obtaining information in microbiology quality control: - The **🔮ATCC** : 📒website, which offers a variety of resources on microbiological quality control, such as white papers, webinars, and products. You can find more information on their website or download their PDF on Microbiological Quality Control as Described in the Compendia. - The **🔮BioPharm International**: 📒website, which publishes articles on best practices in the QC micro laboratory, such as how to design and implement a quality control program, how to perform method validation and suitability testing, and how to use reference materials and standards. You can read their article on Best Practices in the QC Micro Laboratory or browse their other topics on microbiology. - The **🔮Pharmacopeia** : 📒documents, which provide official standards and guidelines for microbiological quality control of pharmaceutical products, such as microbial enumeration testing, antimicrobial effectiveness testing, and sterility testing. You can access the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), or the Japanese Pharmacopoeia (JP) online or in print. #Microbiology #QC #pharmaceutical #food #chemistry #Bacteria #Fungi #USP

𝗛𝗼𝘄 𝘁𝗼 𝗽𝗲𝗿𝗳𝗼𝗿𝗺 𝗥𝗶𝘀𝗸 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁?🔻🔻 To perform risk assessment in EM, you need to follow these steps:🥼🥼 ▪️Identify the potential sources of contamination, such as air, surfaces, personnel, equipment, utilities, etc. ▪️Evaluate the probability and impact of contamination on the product quality and patient safety ▪️Define the monitoring methods, locations, frequencies, and acceptance criteria based on the risk level ▪️Perform the monitoring activities and collect the data ▪️Analyze the data and identify any trends, deviations, or alarms. ▪️Investigate the root causes and implement corrective and preventive actions. ▪️Review and update the risk assessment and the monitoring plan periodically or when changes occur. #Pharmaceutical #Microbiology #QC #QA #Bacteria #Fungi #Food #Risk_Assessment #Production #Environmental_Monitoring

In order to keep your area dust free and to practice GMP standards, our team has locally developed dust collecting unit to extract small dust or powder particles. We have solutions depending upon your room size and you are most welcome to share your particular requirement with us. #pharmaceutical #food #pakistan #Industry #dustcollector #hospitals #manufacturing #industrial #supportlocal #localmanufacturing