Zamann Pharma Support’s Post

🔍 Discover the Power of Process Validation with Brayearst Validation Consulting! 🔍 Curious about the key to ensuring consistent quality in manufacturing processes, especially in the dynamic life sciences and medical device industries? Dive into our latest blog post on the significance of process validation! 🚀 Learn how process validation guarantees product safety, efficacy, and regulatory compliance, paving the way for seamless production that meets the highest standards. Want to delve deeper into the stages of process validation and its pivotal role in quality management? Click below to explore more insights! 🔎💡 Don't miss out on expert tips and statistics revealing the impact of process validation on reducing product recalls and enhancing operational efficiency. Brayearst Validation Consulting is your trusted partner for tailored process validation services—let's optimize your operations together! 💼💡 Ready to elevate your manufacturing processes? Click through to our blog for a detailed look at the world of process validation! 👇✨   https://lnkd.in/eQbA8CK4 #ProcessValidation #QualityAssurance #Regulatory

Ever wonder what goes into ensuring top-notch quality assurance? We're especially committed to exceeding expectations, particularly within the highly regulated pharmaceutical and biologics industries. Head over to our latest blog where our Director of Quality dives deep into our approach to QA, and describes how we integrate it into our company culture. #QualityAssurance #pharmaceuticals #biologics #LifeSciences

Validation Gap Analysis. Validation Gap Analysis is the process of comparing actual performance to an expected performance, to determine whether validation requirements and expectations are being met. Gap analysis seeks to answer the questions “where are we” (current state) and “where do we want to be” (target state). https://lnkd.in/eusD_EuY #validation #pharma #pharmaceutical

For EVERYONE in the manufacturing industry this is a MUST READ! DOWNTIME is an acronym for the eight wastes the Lean Six Sigma (LSS) methodology aims to eliminate. #foodforthought #MasterControl #manufacturing #pharmaceutical #leansixsigma #MES #QMS #Qualtitymanagement https://lnkd.in/greEmeYC

💊WEEKEND REFRESH ON PROCESS VALIDATION 💊 💠 Lifecycle approach to process validation 💠 Phase 1️⃣: Process design 💠Phase 2️⃣: Process performance qualification (PPQ)💠 ‼️Phase 2 involves confirming that the commercial-scale manufacturing process: ✅functions in a state of control ✅consistently produces product meeting its critical quality attributes Starting the PPQ study represents the end of development and beginning of #commercialmanufacture. 1️⃣ Conduct a #readinessassessment to verify that you are ready to start PPQ batch manufacture. Items to verify in a readiness assessment include the following: 💊adequate manufacturing understanding/controls have been established from the process design phase 💊manufacturing instructions are sufficiently detailed to ensure batches are manufactured in a reproducible manner 💊facility, equipment and systems are ready for commercial batch manufacture 💊analytical methods have been validated 💊 all manufacturing and validation personnel are adequately trained 2️⃣ Manufacture #PPQbatches at commercial scale, according to GMP requirements and the manufacturing process/parameter ranges established during Phase 1. 3️⃣Consider whether qualification batches should be enrolled into the ongoing stability program. ‼️ Although a three-batch qualification effort has long been the industry norm, your risk assessment may result in a recommendation to evaluate a different number of batches. ‼️ It is generally expected that you will conduct PPQ studies in a prospective manner. #Concurrentvalidation may be acceptable in exceptional circumstances, for example, where there is a strong benefit-risk ratio for the patient. ‼️ It is expected that the lots for PPQ will be made consecutively. items to consider challenging during the process qualification study execution include the following (if practical and relevant). ✅ Different API and critical excipient lots. ✅ Interchangeable equipment. ✅ Different personnel ✅ Production interruptions ✅ Hold times and process durations. ✅ Reprocessing ‼️👀 Ensure your Process Performance Qualification (PPQ) protocol clearly outlines and justifies all #sampling and #testingrequirements (including test methods). ‼️The PPQ study #acceptancecriteria should demonstrate the manufacturing process is adequately controlled and produces consistent results. ‼️👀 Summarize PPQ study results in a final report. Your report should also include a conclusion that clearly states that the manufacturing process is considered to be one of the following: ✅ Qualified ✅ Not qualified ‼️ An option you may use when planning for #processperformancequalification is continuous process verification, as introduced in ICH Q8 (R2): Pharmaceutical Development. If you like this post follow me on LinkedIn for part 3c:Phase 3️⃣: Ongoing process verification

Managing tasks as a QA executive in a biopharmaceutical company involves ensuring product quality and compliance with industry standards, while also overseeing a range of critical activities. Here's a structured approach to effectively manage your tasks: 1. Prioritize Regulatory Compliance -Understand Guidelines: Keep up with GMP (Good Manufacturing Practices), FDA, and EMA regulations. Regularly review updates from relevant bodies. -Audit Readiness: Prepare for both internal and external audits by maintaining clean and accurate documentation. -Documentation Control: Oversee the maintenance of documentation related to quality systems, product testing, and validation reports. Implement an effective document control system to ensure compliance. 2. Batch Record Review -Ensure Accuracy: Review batch records to ensure that every production process meets quality standards and is properly documented. Verify that deviations are properly recorded and justified. -Investigate Deviations: Lead investigations into any deviations from production standards, such as batch failures or OOS results, and implement CAPA. 3. Coordinate with Cross-functional Teams -Collaborate with R&D and Production: Work closely with R&D, production & engineering teams to align quality control measures with the product development lifecycle. -Training: Develop and conduct training programs to ensure that employees across departments understand and implement quality procedures correctly. 4. Continuous Process Improvement -Data Analysis: Use quality metrics to identify trends in product quality and for improvement. Utilize statistical process control tools to analyze the data and suggest process improvements. -Risk Management: Conduct regular risk assessments to identify potential quality issues earlier. Use tools like FMEA (Failure Mode and Effects Analysis) to evaluate and mitigate risks in manufacturing and quality systems. 5. Supplier Quality Management -Supplier Audits: Perform audits and reviews of raw material suppliers & vendors to ensure they meet the required quality standards. -Raw Material Testing: Oversee the testing of incoming raw materials to ensure they meet specifications before being used in production. 6. Product Release -Release Authority: Having final authority to approve or reject products based on the test results and compliance with quality standards. -Review and Sign Off: Review final product reports, validation, and qualification reports before product release. 7. Handle Customer Complaints -Complaint Investigation: Investigate customer complaints related to product quality and use this feedback to drive continuous improvement. 8. Focus on Compliance Software -Electronic Systems: Manage quality management systems (QMS) software to streamline documentation, change control, deviation reporting, and audit trail reviews. Utilize tools like TrackWise or MasterControl for QMS management.

Change Control is a critical component of Quality Management Systems (QMS) in the pharmaceutical industry. It ensures that any changes to processes, equipment, materials, documentation, or facilities are systematically evaluated, documented, and approved before implementation to maintain compliance with regulatory requirements and ensure product quality and safety. Key Elements of Change Control in Pharmaceuticals 1. Purpose and Scope Ensure all changes are assessed for their potential impact on product quality, regulatory compliance, and patient safety. Apply to manufacturing, packaging, labeling, testing, and distribution processes. 2. Types of Changes Changes can be categorized based on their impact: Minor Changes: Minimal risk (e.g., editorial changes in SOPs). Major Changes: Significant impact on product quality or regulatory status (e.g., changing raw material suppliers). Critical Changes: High impact on product quality, requiring thorough validation and regulatory approval (e.g., changes to manufacturing processes or critical equipment). 3. Steps in the Change Control Process Initiation: Identify the need for change and provide a detailed description, rationale, and potential impact assessment. Impact Assessment: Evaluate the effect of the change on: Product quality. Regulatory filings and approvals. Manufacturing and validation processes. Risk Assessment: Use tools like FMEA (Failure Modes and Effects Analysis) to determine risks. Approval: Obtain authorization from the Change Control Board (CCB), which includes representatives from Quality Assurance (QA), Regulatory Affairs, and other relevant departments. Implementation: Carry out the approved change, ensuring all required training and updates to documentation are completed. Verification: Confirm that the change has been implemented as planned and is effective. Closure: Document the completion and review of the change. 4. Roles and Responsibilities Initiator: Proposes the change and provides initial details. Change Control Board (CCB): Reviews, assesses, and approves/rejects changes. Quality Assurance (QA): Ensures that the change complies with regulatory standards. Regulatory Affairs: Assesses if regulatory filings or notifications are required. 5. Documentation Requirements Change Control Form (CCF) to record all details of the proposed change. Risk assessments, validation plans, and any required regulatory submissions. Updated SOPs, batch records, and other relevant documentation. 6. Regulatory Expectations Compliance with regulatory guidelines from agencies like: FDA (21 CFR Part 211 - cGMP for Finished Pharmaceuticals). EMA (EU GMP Annex 15 - Qualification and Validation). WHO (Good Manufacturing Practices). 7. Examples of Changes Process changes (e.g., altering manufacturing parameters). Equipment updates (e.g., new machinery installation). Packaging design or material modifications. Software or IT system updates impacting manufacturing or quality.

Short note: Companies often find it confusing to choose between quality management methods like Quality Assurance (QA), Six Sigma, and Kaizen because each serves a different purpose and may not fit every industry. For example, QA is commonly used in the pharmaceutical industry to ensure products meet strict safety standards, while Six Sigma is popular in manufacturing to minimize defects in production. On the other hand, Kaizen is widely applied in retail and service industries to improve processes through employee involvement. However, it’s important not to overwhelm employees with too many concepts or unnecessary complexity. Instead, businesses should focus on making their approach lean and effective by selecting the method that best aligns with their specific needs, industry, and quality goals.

Performance Qualification Experience | Pharmaceutical Manufacturing 💊⚙️ It's crucial to conduct Performance Qualification (PQ) before moving to Process Validation to ensure machinery functions correctly and consistently. Recently, I had the opportunity to document the Performance Qualification Protocol (PQP) and Performance Qualification Report (PQR) for the Octagonal Blender and Auto Coater of our 25 kg Oral Solid Dosage (OSD) production line. Through this experience, I not only engaged in the processes of blending and coating, but I also collaborated with the Quality Assurance (QA) and Quality Control (QC) teams to ensure compliance with relevant standards. I also had the pleasure of working closely with our QA executive, Buddhini Samaranayake, who supported me throughout the entire process. As an engineer, I focused on controlling key process variables such as pressure, temperature, and Rotations Per Minute (RPM) to achieve the desired outcomes. Thorough testing was conducted to confirm that the machinery performed optimally under the required conditions. This hands-on experience enriched my understanding of the pharmaceutical production process while reinforcing the importance of cross departmental collaboration for successful project outcomes. #PerformanceQualification #PharmaceuticalEngineering #OSDProduction #BlendingProcess #CoatingProcess #QualityAssurance #QualityControl #ManufacturingEngineering #ProcessValidation #PharmaTech #GMPCompliance

🔍 Process Performance Qualification (PPQ) in Biopharma: Key Phases, Components, and Steps for Quality Excellence 🧬 PPQ ensures that each biopharma production process consistently delivers safe, effective products that meet regulatory standards. Here’s a concise breakdown of its phases, components, and key execution steps: 1️⃣ PPQ Phases: 🛠️ Process Design: Defines a robust process with Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensure reproducibility. 🔍 Process Qualification: Confirms that equipment and the entire process meet specifications through: 📝 Installation Qualification (IQ): Verifies equipment setup. ⚙️ Operational Qualification (OQ): Confirms operational consistency. ✅ Performance Qualification (PQ): Validates that the full process meets quality standards. 📊 Continued Process Verification (CPV): Monitors CPPs and CQAs to ensure ongoing compliance and product consistency. 2️⃣ PPQ Key Components: 🔧 Critical Process Parameters (CPPs): Conditions (e.g., temperature, pH) that affect product quality and are strictly controlled. 📈 Critical Quality Attributes (CQAs): Final product attributes (e.g., purity, potency) essential for safety and efficacy. ⚖️ Balancing CPPs and CQAs is where the art of PPQ comes into play. By identifying and testing these critical points, PPQ helps ensure that scale-up doesn’t introduce variability that compromises product integrity or safety. 3️⃣ Steps in PPQ Execution: 1. 🎯 Define Acceptance Criteria: Establish control limits for CPPs and CQAs based on regulatory standards. 2. 🔄 Execute PPQ Runs: Conduct and test batches to confirm reproducibility. 3. 📉 Analyze and Document: Use statistical tools to confirm compliance. 4. 🗂️ Review and Submission: Compile data into a regulatory report to demonstrate process control. 5. 🔎 Ongoing Monitoring: Transition to CPV to sustain process stability and enable continuous improvement. ✨ Why PPQ Matters: PPQ is vital for regulatory compliance, product integrity, and patient safety. By emphasizing careful design, rigorous testing, and proactive monitoring, PPQ supports quality excellence and helps bring life-saving therapies to patients. A Well-executed PPQ ensures compliance with FDA and EMA standards, enables seamless batch reproducibility, minimizes the risk of deviations, and optimizes manufacturing efficiency. In short, PPQ isn’t just a regulatory requirement—it’s a cornerstone of operational excellence and patient safety in the biopharma industry.🌍💊 #PPQ #BiopharmaManufacturing #QualityControl #GMPCompliance #ProcessValidation #Biotech #Biopharma #GMP #ManufacturingExcellence #Quality