Srinivasulu Ale

Naveen Agarwal, Ph.D. My humble opinion, on FDA gibberish. What does "FDA expects that correction and prevention of unacceptable QS practices should result in nonconformities related to the product” mean? Not all, in fact many NC don’t rise to the level of a CAPA. NC are related to the manufacturing process from bad raw materials to bad execution of a WI. Trending will ultimately reveal how bad etc. The nonconformity is related to the process of making the device, not the final device. If the final device does not meet validated and approved specs than you a faulty issue in the manufacturing from design to finished device release processes. It’s nonconformity related to the process and it’s materials that resulted in a bad product. It wrong to word it by saying NCs related to the product. Quite simply by saying the NC related to the product is too late to baptize it as a NC it’s a CAPA. FDA as always complicates things by its own verbiage, call it a NC or call it it a CAPA but don’t mix them up. If you do you’re disrespecting a CAPA. This is how you managed bad product by addressing how it ended up being bad. One of FDA favorite "got you” items on a 483 is not executing set criteria to elevate a NC to a CAPA. Yes ultimately to prevent those NC s from reoccurring to end up with a bad product. It’s about the process.

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The Central Drugs Standard Control Organization (CDSCO), in collaboration with the Food and Drug Control Administration (FDCA) Gujarat and the Indian Drug Manufacturers Association (IDMA), is set to conduct an insightful one-day workshop focusing on "Vendor Validation/Audit as per the Revised Schedule M Guidelines." The workshop will be held on November 30, 2024

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The Central Drugs Standard Control Organization (CDSCO), in collaboration with the Food and Drug Control Administration (FDCA) Gujarat and the Indian Drug Manufacturers Association (IDMA), is set to conduct an insightful one-day workshop focusing on "Vendor Validation/Audit as per the Revised Schedule M Guidelines." The workshop will be held on November 30, 2024 in Ahmedabad

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FDA Issued Warning Letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd. On July 11, 2024, the FDA issued a warning letter for critical data integrity issues, Inadequate Facility Design, and Aseptic Processing Problems. 🔍 Critical Data Integrity Observations are: 1. Serious QA Deficiencies: Discarded original CGMP records were stacked in a bag underneath a vehicle and in a nearby trash can. 2. Unrestricted Access: The production manager had unrestricted access to blank production batch records and other CGMP documents without QA issuance. 3. Uncontrolled Document Handling: The production manager repeatedly accessed and printed uncontrolled blank copies of production records, media fill records, visual inspection records, process validation batch records, and cleaning validation records. When production employees reported an “error” in a record, the production manager printed a blank copy, had the employee transcribe the information onto the new record, and discarded the old one. This practice severely compromises the assurance that archived data is original or accurate. This warning letter underscores the importance of stringent data integrity and compliance with CGMP regulations in the pharmaceutical industry. Ensuring accurate and original records is crucial for maintaining trust and safety in pharmaceutical manufacturing. For details, please take a look at the attached warning letter. .....and what is your practice on similar issues? #Pharmaceuticals #FDA #DataIntegrity #QualityAssurance #Compliance #CGMP

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FDA DRAFT GUIDANCE: Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics. Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. #fda #guidance #expedite #drugs #biologics

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In January 2024, the USFDA issued revisions to the cGMP requirements for finished medical devices, now referred to as the Quality Management System Regulation (QMSR). The QMSR aligns more closely with the ISO 13485:2016 standard. The QMSR replaces the 21 CFR Part 820, which was the regulatory framework for CGMP for Medical Devices. While Part 820 focused on ensuring consistency in manufacturing practices, QMSR incorporates broader quality management principles by embedding risk management and continuous improvement processes from ISO 13485.

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Aseptic filling is crucial for ensuring the sterility and safety of drug products in addition to being compliant with regulatory agencies. Following procedures can be taken to ensure Proper Filling 1. **Controlled Environment and closed system:** Use cleanrooms with HEPA filters to maintain sterile conditions. 2. **Personnel Training and proper PPE:** Train staff in aseptic techniques and hygiene practices. 3. **Equipment Sterilization and calibration:** Regularly sterilize and ensure equipment is within calibration. 4. **Process Validation:** Validate aseptic processes through media fill tests. By adhering to these practices, the risk of contamination can be minimized, ensuring the safety and effectiveness of the drug product.

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Industry Institute partnership- Need of hours Academica is the source of Human Resources. Teach, Train and Skill what industry is needed. This is one of my favourite topic. This should be looked more practical solutions then a academic discussion. Few companies like Tata Consultancy Services have MoU with universities and help to bring Life Science skilled resources. Question is who has to initiate first? Industry or academic? SCDM India Sarvesh Singh Shrishaila Patil K and others

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📢 IPO GMP Update as of Dec 15 📢 ✨ Vishal Mega Mart: ₹18-19 (+23%) ✨ Mobikwik Systems: ₹161-165 (+28%) ✨ Sai Life Sciences: ₹60-63 (+11%) ✨ IGI: ₹90-92 (+22%) ✨ Inventurus Knowledge: ₹400-405 (+30%) ✨ Mamata Machinery: ₹90-92 (+37%) 💡 GMP is based on market rumors and NOT a guaranteed indicator of listing price. For educational purposes only—do your own research before investing! ⚠️ Disclaimer: @stock.insighthub posts are purely for educational purposes and do not promote any specific IPO or stock. We’re not responsible for financial decisions taken by investors. 👉 Follow us on LinkedIn, Instagram, Threads, Telegram, Facebook, Twitter, Quora, Pinterest, Snapchat, Blogspot, and YouTube for more newsletters & updates! #IPO #GMP #StockMarket #Investing #StockUpdates #StockInsights #InvestmentTips #StockMarketIndia #FinancialPlanning #IPONews

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🔍 FDA guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products 📝 The FDA has issued draft guidance for manufacturers of biosimilar and interchangeable biosimilar products regarding postapproval manufacturing changes. This guidance provides recommendations for holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs), as well as holders of drug master files (DMFs) and veterinary master files (VMFs). If you’re involved in drug substance manufacturing, this information is crucial during the postapproval period. #FDA #biosimilars #manufacturingchanges #pharmaceuticals 👩‍⚕️🔬

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ICH Q3C (R9) Guideline on impurities: guideline for residual solvents Step 5 Change history: Adoption of Minor revision to section 3.4. including consideration of solvent volatility for analytical methods, (section 3.4., page 4) by the Regulatory Members of the ICH Assembly under Step 4, following the ICH minor revision procedure. #medicinalproducts #produktylecznicze #pharma #gmp #ich #impurities #ffp

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A deficiency that I often see as a GMP auditor is to 21 CFR Part 820.250 Statistical Techniques. The FDA has purposely been vague here as there are only a few sentences dedicated to this clause, which allows manufacturers to be flexible with realizing this requirement. Below are common statistical techniques that can be applied and scenarios in which they may be suitable: ✅ Statistical Process Control - Suitable as a monitoring tool to measure process capability (i.e. Cp/K) and proactively identify trends such as out-of-tolerance drifting. For example, I want to measure, in real-time, the seal strength of a sterile pouch to ensure integrity of the sterile barrier. ✅ Acceptance Sampling - Suitable as a risk-based sampling methodology for evaluating the quality of a product lot. For example, I've received 1000 widgets from my supplier and I want to determine if it's a "good lot" without having to inspect each widget. ✅Regression Analysis - Suitable for determining whether there is a relationship between "X" and "Y." For example, I want to show that a process change (X) I've made does not adversely affect the product specifications (Y). ✅ Hypothesis Testing - Suitable for proving whether a certain claim is true. For example, I want to show that Drug "A" has a therapuetic effect on reducing colon cancer tumor size compared to the placebo. #FDA #GMP #StatisticalTechniques

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Rational Statistical Analysis Practice in Dissolution Profile Comparison for Product Quality Assessment of Similarity through Real Case Studies: Industry Perspective

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Relationship between CQA and CPP In pharmaceutical manufacturing, critical quality attributes (CQAs) are the characteristics of a drug product that are essential for ensuring its safety, efficacy, and quality. Critical process parameters (CPPs) are the variables that can affect the CQAs during the manufacturing process. Establishing a relationship between CQAs and CPPs is crucial for maintaining product quality and consistency. The following steps can be taken to achieve a relationship between CQAs and CPPs in pharmaceutical manufacturing: 1. Identify the CQAs: The first step is to identify the critical quality attributes of the drug product. This can be done by analyzing the product specifications, regulatory requirements, and customer needs. 2. Identify the CPPs: Once the CQAs are identified, the next step is to determine the critical process parameters that can affect these attributes. This can be done by conducting a risk assessment and analyzing the manufacturing process. 3. Establish a relationship: After identifying the CQAs and CPPs, it is important to establish a relationship between them. This can be done by conducting experiments to determine how changes in the CPPs affect the CQAs. Statistical tools such as Design of Experiments (DOE) can be used to analyze the data and establish a correlation between the two. 4. Develop control strategies: Based on the relationship established between CQAs and CPPs, control strategies can be developed to ensure that the manufacturing process is within acceptable limits. This can include setting control limits for CPPs, monitoring process parameters in real-time, and implementing corrective actions when necessary. 5. Validate the process: Once the control strategies are in place, it is important to validate the manufacturing process to ensure that it consistently produces a product that meets the desired quality attributes. This can be done by conducting process validation studies and analyzing the data to ensure that the process is robust and capable of producing a consistent product. By establishing a relationship between CQAs and CPPs, pharmaceutical manufacturers can ensure that their products are safe, effective, and of high quality. This can help to reduce the risk of product recalls, improve customer satisfaction, and ensure compliance with regulatory requirements.

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A protocol for the validation of qualitative methods of detection https://lnkd.in/gFtzeUYc #analytguru #analytical #analyticalchemistry #analyticalchemistry #analyticalconsultant #analyticaldevelopment #analyticalexpert #AnalyticalMethodValidation #chromatography #ChromatographyTalk #cleaningvalidation #cphi #gcms #hplc #lcms #liquidchromatography #methoddevelopment #methodvalidation #methodverification #nitrosamines #pharma #pharmaceutical #pharmaceuticalconsultant #pharmaceuticals #researchanddevelopment #residualsolvents #responsive #smallmolecules #stability #USP #validation #capacity #customerservice #fast #quickturnaround #resources #responsive #services #turnaroundtimes #consulting #business #marketing #consultant #coaching #entrepreneur #management #leadership #smallbusiness #training #success #startup #strategy #managementconsulting #businessconsulting #accounting #work #innovation #entrepreneurship #projectmanagement #excellence #highperformance #quality #qualitycontrol #qualityassurance #manufacturing #laboratory #laboratoryservices #leanmanufaturing #GMP #audit

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#secret The secret to being great at sales? It’s simple – we believe in what we’re selling. When we truly trust our product or service, it shows in every conversation. Our energy becomes contagious, and clients can feel that authenticity...... #people don’t just buy products, they buy the confidence and passion we have for them. selling with heart is the need, not by just words...... keeping it real & genuine is the need.... #SalesTips #SalesLife #BelieveInYourProduct #AuthenticitySells #SalesMindset #TrustTheProcess #CustomerConnection #BeGenuine #SellWithConfidence #SalesJourney #SalesHustle #SalesSuccess #PassionForSales #RelationshipBuilding #SalesSkills #PositiveVibes #RealTalk #SalesStrategy #SalesGoals #WinWithConfidence #KeepItReal

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Honey fraud detection based on sugar syrup adulterations by HPLC-UV fingerprinting and chemometrics https://lnkd.in/gMb8s8tF #analytguru #analytical #analyticalchemistry #analyticalchemistry #analyticalconsultant #analyticaldevelopment #analyticalexpert #AnalyticalMethodValidation #chromatography #ChromatographyTalk #cleaningvalidation #cphi #gcms #hplc #lcms #liquidchromatography #methoddevelopment #methodvalidation #methodverification #nitrosamines #pharma #pharmaceutical #pharmaceuticalconsultant #pharmaceuticals #researchanddevelopment #residualsolvents #responsive #smallmolecules #stability #USP #validation #capacity #customerservice #fast #quickturnaround #resources #responsive #services #turnaroundtimes #consulting #business #marketing #consultant #coaching #entrepreneur #management #leadership #smallbusiness #training #success #startup #strategy #managementconsulting #businessconsulting #accounting #work #innovation #entrepreneurship #projectmanagement #excellence #highperformance #quality #qualitycontrol #qualityassurance #manufacturing #laboratory #laboratoryservices #leanmanufaturing #GMP #audit

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EI (emotional intelligence) in the world of AI (artificial intelligence) In the world fascinated with AI, the role of EI is becoming more & more relevant. Emotional Intelligence is the ability to understand and manage your own emotions, as well as to recognize and influence the emotions/ feelings of others. It enhances mental health, relationships, and of course performance. Here's how you can cultivate emotional intelligence:   Practice Mindfulness - Remaining present in the moment is essential for getting into the state of awareness. Awareness that helps you understand your emotions and observe its influence on your mind and body.   Foster Empathy - Showing compassion to others when they express their feelings is not just a sign of emotional intelligence; it's a powerful tool for building trust and rapport.   Learn Self-Regulation - Responding to any situation rationally, based on logic, is not just a skill; it enables you to express your thoughts clearly and respectfully. Train yourself to stay calm, breathe deep and take breaks to respond instead of react.   Master Communication - Speaking simply and directly will ensure that you convey your message clearly without any dilution. Consider the context, purpose, and goal of your communication. Choice of words matter. Develop Social Skills - Seeking feedback from others will be an important step for improving your interpersonal interactions. Ask for suggestions, listen actively, understand different viewpoints and be open to learn from various perspectives and experiences.   Focusing on these strategies can cultivate EI (emotional intelligence) and significantly boost your workplace joy as well as success. #EI

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