SeerPharma’s Post

Help me to get 100 subscribers in June 2024 for the YouTube GMP Detox Channel.... currently the channel has 96 subscribers. So only 4 are missing for this month. Find 31 clips on YouTube with more than 2000 views in the last 3 month, for example: 💬 GMP Detox Master Batch Record and Batch Production Record:This session delves into master batch records and batch production records, exploring terms and definitions according to EU GMP Chapter 4 and US-FDA CGMP 21 CFR Part 211. It’s a fascinating look at the intricacies of GMP processes. 💬 GMP Detox All about Audit Trails:In this session, you’ll learn about audit trails, their definition, and their significance according to US-FDA CGMP 21 CFR Part 11 and EU GMP EudraLex Vol. 4. Dive into the world of data integrity and record-keeping. Find all videos here: https://lnkd.in/e5u7v2yG 💬 GMP Detox CAPA - and what are corrections? Explore Corrective and Preventive Actions (CAPA) in this session. Discover whether CAPA requires root cause analysis, how to apply Quality Risk Management (QRM), and whether CAPA is always necessary.

📢 Take a look at our blog post: "QC Labs - The Three Ways Our New Compliance Package Can Help". Discover how our PURELAB® Pharma Compliance package provides a tailored, easy-to-use combination of equipment and services to ensure a reliable supply of ultrapure water for quality control (QC) laboratory processes. Read more: https://lnkd.in/ez_Uy2hC ⚙️ Our intuitive software ensures seamless integration of the PURELAB® equipment into your lab, with no disruption to water supply or quality. It meets global regulators' best practices for data management and provides evidence for FDA and EU standards. 📝 We offer different levels of purified water validation, from water dispenser systems to GLP validation and FDA 21 CFR part 11 compliance. Installation Qualification (IQ) and Operational Qualification (OQ) documents are included in the package. #ultrapurewater #QClabs #waterpurity #compliance

GMP REFRESH‼️ Deviation Management Flow in Regulated Industry- Part III Risks evaluation for classifying the deviations 💠FOREWORD💠 #Deviations are categorized based on #risk levels to assess their potential impact on product #quality, #patientsafety, and the #regulatoryrequirements companies are subject to. 💠CATEGORISATION💠 The categorization of deviations may vary based on the nature of the product, industry requirements, and the company’s #riskmanagement needs. The first step is to identify if the event has a significant impact on the manufacturing process parameters, SOPs, or cGMP. If the event does not have a significant impact, then the event is considered an incident. The risk-based deviation categories usually include: ✅Incidents ✅ Minor deviations ✅ Major deviations ✅ Critical deviations 💠Incident (or opportunity for improvement)💠 "You might like to think about..." An #OFI is an unplanned or uncontrolled event that does not directly affect the manufacturing process parameters or product quality. However, its occurrence may merit a change in process to secure future efficiencies and further minimise risk. Examples of incidents are reported below: ➡️ Accidental material spillage occurred in the cleanroom. ➡️ Personnel not appropriately dressed inside the production area. 💠Minor💠 "Fix when you can" A minor deviation involves divergences from established procedures or standards that have a noticeable but limited impact on product quality or compliance capabilities. Examples of minor deviations are reported below: ➡️ A slight variation in the size or appearance of a product that does not affect its efficacy or safety. ➡️ Documentation errors that do not compromise data integrity. 💠Major💠 "Make this a high priority" A major deviation indicates a significant departure from required procedures or standards that impacts a product’s quality, safety, or efficacy but may not directly impact patients. Examples might include: ➡️ A deviation in the manufacturing process results in an out-of-specification (#OOS) product requiring investigation and corrective actions to prevent further occurrences. ➡️ A failure of critical equipment during production leads to a potential impact on product quality. 💠Critical💠 "Drop everything and fix this immediately" A critical deviation is a severe non-conformance from established procedures or standards that poses urgent risks to product quality, patient safety, or compliance with regulatory requirements. Examples might include: ➡️ Contamination of raw materials. ➡️ Failure of clean room protocols. ➡️ Detection of an OOS product requiring investigation and correction.

📑As we continue on our GMP journey, another common mistake I see often is documentation errors. This includes incomplete or inaccurate documentation of cleaning logs, laboratory records and batch documents - to name a few. These oversights can snowball into compliance issues, rejected batches, and delays. 🌱 Head over to the RegPartners page to read our latest post with practical tips on avoiding these mistakes and ensuring your records are always audit-ready! #QualityCompliance #Documentation #QualityTips #GMPBasics

GMP inspections are critical in upholding quality, safety, and regulatory compliance in the pharmaceutical world. Here’s a quick roadmap to keep your team ready and confident: 1️⃣ Conduct Internal Audits: Identify gaps early and proactively address non-conformities. 2️⃣ Document Everything: Keep SOPs, batch records, and logs current and accessible. 3️⃣ Ensure Cleanliness: Maintain clean, organized facilities to prevent contamination. 4️⃣ Form an Inspection Team: Designate roles for efficient interaction with inspectors. 5️⃣ Review Past Reports: Learn from previous inspections to continuously improve. 6️⃣ Train Staff: Equip employees with the skills to handle inspection protocols. 7️⃣ Set Up a Readiness Plan: Organize tasks, timelines, and responsibilities. 8️⃣ Practice with Mock Inspections: Prepare your team under real inspection scenarios. 9️⃣ Plan an Inspection Route: Map out an efficient path for inspectors. 🔟 Establish a War Room: Centralize coordination and quick responses on inspection day.

As we continue our GMP journey, let's dive into Common GMP Mistake #3: Documentation Errors 📂 Errors in documentation, like incomplete cleaning logs or batch records, can lead to compliance gaps, regulatory findings, and delayed batch releases. In our latest post, we explore how these errors happen, why they’re a problem, and actionable tips to prevent them. 👉 Don’t let documentation derail your compliance. Read now to learn how to stay on top of it. #GMPCompliance #Documentation #QualityTips #GMPBasics

Common challenges in cleaning validation i 1. *Residue identification*: Detecting and identifying residues, especially at low levels. 2. *Sampling methods*: Ensuring representative sampling, covering all critical areas. 3. *Analytical methods*: Selecting suitable analytical techniques for residue detection. 4. *Recovery studies*: Demonstrating adequate recovery of residues during sampling. 5. *Equipment complexity*: Validating complex equipment with hard-to-reach areas. 6. *Regulatory compliance*: Meeting diverse regulatory requirements (e.g., FDA, EU GMP). 7. *Documentation*: Maintaining comprehensive, accurate documentation. 8. *Operator training*: Ensuring personnel understand cleaning procedures and validation. Addressing these challenges requires careful planning, execution, and ongoing monitoring to ensure effective cleaning validation and compliance.

🚀 WHO GMP Audit Checklist! An exclusive checklist based on WHO GMP Guidelines. 🔑 Key Areas Covered in the Checklist: 1️⃣ Personnel & Training – Job descriptions, qualifications, and GMP training programs. 2️⃣ Facility & Equipment – Cleanroom classification, HVAC, water systems, and calibration. 3️⃣ Production & Documentation – Batch records, validation, and deviation management. 4️⃣ Quality Control & Assurance – Sampling plans, in-process checks, and laboratory compliance. 5️⃣ Packaging & Labeling – Label reconciliation, segregation, and traceability. 6️⃣ Storage & Distribution – Quarantine, cold chain management, and product recall systems. 7️⃣ Sanitation & Pest Control – Waste management and contamination prevention. 📄 Check out WHO GMP Checklist Let’s connect and discuss how I can help your team ensure seamless FDA/EU GMP compliance! ✔️ By identifying and addressing GMP compliance gaps. Share your thoughts & comments. Tag your peers who can benefit from this resource. #AnalyticalMethodValidation #PharmaceuticalCompliance #GMPCompliance #FDA483 #QualityControl #RegulatoryAffairs #PharmaExcellence #Pharmaindustry #Biotech #Training #Compliance #PharmaQuality #DataIntegrity #PharmaCompliance #QualityControl #WHOChecklist #PharmaQuality

cGMP (current Good Manufacturing Practice) 1. Facility Design: Cleanroom environments, controlled temperature, and humidity. 2. Equipment Validation: All equipment must be validated for consistent performance. 3. Quality Control: Rigorous testing of raw materials and finished products. 4. Documentation: Comprehensive record-keeping for traceability and accountability. 5. Training: Regular training for personnel on cGMP regulations and practices. 6. Contamination Control: Protocols to minimize risks of contamination. 7. Process Validation: Ensuring that manufacturing processes consistently produce products meeting quality specifications.

What is a major deviation in GMP? A major deviation in Good Manufacturing Practice (GMP) refers to a significant departure from established procedures or standards that can potentially impact the quality, safety, or efficacy of a product. These deviations could arise from various sources, including: Process Errors: Failure to follow standard operating procedures (SOPs) during manufacturing. Equipment Malfunctions: Breakdowns or inappropriate maintenance that affect the production process. Material Issues: Use of non-conforming raw materials or components that do not meet specifications. Documentation Errors: Inaccurate or incomplete recording of critical manufacturing data that hinders traceability and accountability. Major deviations require immediate investigation and corrective action, as they can lead to significant risks, including product recalls, regulatory penalties, and compromised patient safety. Typically, they must be documented in a deviation report, which outlines the nature of the deviation, its impact, the root cause, and the corrective actions taken to prevent recurrence. #GMP_Deviation https://lnkd.in/dyRSQFhj