Quanta part of QCS Staffing’s Post

«"Out of Specification" ( OOS )» Out of specification results are not rare in pharmaceutical industries but their investigation and finding the real root cause is time consuming process and includes many steps. Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the predefined limits for that particular product. The possible causes of the OOS can be 1. analytical error where a product doesn’t have any defect but it has a problem in its analysis and the other one is a manufacturing defect in the product where analysis is correct but the product actually has a problem. The following are the possible causes for out of specification results:- 1. Test analysis error in QC lab 2. Lab equipment malfunctioning 3. Production equipment malfunctioning 4. Operator/human errors in manufacturing 1. Test Analysis Error in QC Lab: Error in the QC lab is human or analyst error. This is the most probable cause of the OOS and should be investigated first during the investigation of OOS. During the analysis of the product, there may be an error during the handling of the sample or standard. There may be an error in sample weighing and its dilution. Errors are also possible in chromatography and titration or even in the calculation. 2. Lab Equipment Malfunctioning: Due to this problem analysis is also unaware of the occurrence of this error. Sometimes equipment or instruments are not calibrated at the due date and it shows the incorrect results due to which product results deviate the limits. While in some other cases it happens due to malfunctioning of the equipment or instrument used in the analysis. 3. Production Equipment Malfunctioning: This causes the actual defect in the manufactured product. Malfunctioning of equipment may include errors in timers or any other part of the equipment that is not noticed during the manufacturing process. 4. Operator/Human Errors in Manufacturing: Operators play an important role in the manufacturing of quality products. It happens when the operator doesn’t follow the instructions given in the batch manufacturing record. It is always very difficult to find a human error responsible for out of specification results because it may hide the errors done by him and sometimes it is done unintentionally and found correctly in documents. #OoS #Chemistry #Analytical_Chemistry #Pharmaceutical. #Laboratory

➡ Are you curious about the essential process of Commissioning and Qualification for analytical instruments in the pharmaceutical industry? 🧪💼 We have a must-read article that sheds light on this critical topic! At PQE Group, we understand the significance of ensuring 'fitness for purpose' for analytical instruments in pharmaceutical laboratories. 🏭💡 From simple instruments to complex HPLCs with computerized systems, each instrument plays a vital role in generating integral and reliable data. Our latest article emphasizes the importance of Qualification of Analytical instruments and how it impacts data quality. 📊🔬 Whether you're a seasoned professional or someone eager to learn, this article provides valuable insights into the validated state of instruments and the risk-based approach to conducting Analytical Instrument Qualification (AIQ). 🌐🤝 Join us in embracing this scientific journey to achieve robust, secure, and consistent data while adhering to compliance standards. 🚀📚 Let's explore the classification and categorization of analytical instruments and gain a deeper understanding of their significance in our industry. Read the full article here: https://lnkd.in/djbRrzpN. Equip yourself with the knowledge needed to excel in the world of analytical excellence! 🌈💼 #pqegroup #analyticalinstruments #aiq #dataquality #pharmaceuticalindustry #compliancestandards #scientificexcellence #AnalyticalExcellence #KnowledgeSharing #PharmaCommunity #StayInformed

💊MONDAY REFRESH ON PROCESS VALIDATION 💊 💠 Lifecycle approach to process validation 💠 Phase 2️⃣: Process performance qualification (PPQ) 💠CONTINUOUS PROCESS VERIFICATION 💠 #Continuousprocessverification is an alternative approach to #traditionalprocessvalidation in which manufacturing process performance is continuously monitored and evaluated #ICHQ8 (R2): Pharmaceutical Development. ‼️Note‼️ This term is different from the term #continuedprocessverification used by the US #FDA Process Validation: General Principles and Practices to describe the ongoing monitoring phase following formal process performance qualification. ➡️👀The term used by the US FDA corresponds with Phase 3 in this document - Ongoing process verification. ➡️ Continuous process verification” is not a “part of” process validation (as in the FDA description of “continued process verification”). ‼️Rather “continuous process verification” is done in place of process validation.‼️ To successfully implement a continuous process verification, you need: ✅ information to indicate that the manufacturing process is capable of consistently producing product meeting the #QTPP ✅ extensive process understanding: continuous process verification is appropriate when an enhanced development approach (e.g. quality by design) has been followed, or when commercial manufacture has led to extensive process knowledge ✅ suitable #controlstrategies: these can include on-line, at-line or in-line monitoring whether or not there is forward or backward feedback. Tools such as #ProcessAnalyticalTechnology and #multivariatestatisticalprocesscontrol are important to consider in the implementation of continuous process verification ‼️👀Ensure the rationale to use continuous process verification is clearly stated and justified within development reports, submission documents and qualification/monitoring protocols. ‼️👀You should determine and justify the number of batches to be assessed using continuous process verification using risk based principles. ‼️👀Clearly define the point at which a product will be considered to be qualified and the basis on which that decision will be made before release of batches. A #monitoringprogram should be implemented to monitor quality and to detect trends. A #riskassessment should be performed to determine which parameters to monitor and trend. It may be necessary to implement #additionalcontrols for a period of time, when less is known about the process or when an adverse trend is suspected. ‼️You can conduct continuous process verification following a #holisticapproach (entire manufacturing process) or #hybridapproach (where it is applied to a portion of a manufacturing process, together with a traditional validation approach). It can also be introduced at any time during the lifecycle of a product. If you like this post follow me on LinkedIn for part 3d:Phase 3️⃣: Ongoing process verification Picture:Pharmatechassociates

CAD (Clean & Aseptic Design) valves were created by experienced pharmaceutical process and operations engineers. These engineers were convinced that some non‐productive but extremely necessary processes (especially CIP & SIP) in our industry have potential for improvement which can result in substantial overall productivity increases for pharmaceutical facilities. #Rodesta #CAD #Valves #Aseptic #Pharma #Installation #Valves #StainlessSteel #RVS #Pharma #Foodindustry #CIPcleaning

☝️4️⃣🅰️ Document control in the pharmaceutical industry is crucial for ensuring compliance with regulatory requirements, maintaining quality standards, and managing the vast amount of documentation generated throughout the product lifecycle. 📋✅Regulatory Compliance: Pharma companies must adhere to strict regulations set by authorities such as the USFDA, EMA and similar agencies worldwide. 📚✅Document Types: Various types of documents are generated in the pharmaceutical industry, including standard operating procedures (SOPs), protocols, batch records, validation reports, regulatory submissions, documentation, manufacturing instructions, and quality control records. 📒✅Document Lifecycle: Documents in the pharma industry typically go through a lifecycle that includes creation, review, approval, distribution, use, periodic review, and obsolescence. 📝✅Document Control Systems: Pharma companies employ document management systems (DMS) or electronic document management systems (EDMS) to facilitate document control. 🛂✅Version Control: Maintaining control over document versions is critical to ensure that users are accessing the most up-to-date information. 👉✅Access Control: Access to documents is usually restricted based on roles and permissions. Only authorized personnel should have access to certain types of documents, and access levels may vary depending on job responsibilities and the stage of the document lifecycle. 🔍✅Audit Trails: Document management systems maintain detailed audit trails that track all actions taken on documents, including creation, modification, review, approval, and distribution. 📓✅Training and Awareness: Pharma companies provide training to employees on document control procedures and the proper use of document management systems. Employees must understand their roles and responsibilities regarding document creation, review, approval, and storage. 🔄✅Change Control: Changes to controlled documents must be managed through a formal change control process to ensure that changes are properly evaluated, approved, implemented, and documented. 🔍✅Periodic Review and Retention: Documents must be periodically reviewed to ensure that they remain accurate, up-to-date, and relevant. Connect IncepBio or visit www.incepbio.com for ensuring compliance with regulatory requirements and maintain the quality standards. #pharmaceutical #biopharmaceuticals #biotechnology #medicaldevices #documentcontrol #regulatoryrequirements #maintaining #quality #standards #compliance #documents #types #sops #protocols #batch #records #reports #policy #manual #instruction #manufacturing #qc #lifecycle #controlsystems #edms #dms #review #approvals #versioncontrol #accesscontrol #audi #trail #traning #changecontrol #periodic #review #implementation Ajith K Jose Prashanth Hugar Ambarish Ghali Asish Kumar ANAND R PILLAI

The Importance of Calibration in the Pharmaceutical and Life Science Industries- Part 7 How to use and evaluate calibration certificates for ongoing process control and monitoring❓ ⏩Calibration certificates are like the compass guiding our ship of accurate measurements in the complex pharmaceutical manufacturing industry. ⏩They play a pivotal role in ensuring the precision and reliability of our measurement instruments, critical for maintaining quality and compliance. ⏩Here's a quick guide on how we can effectively use and evaluate calibration certificates for ongoing process control and monitoring. · Understand the Contents: Dive into the details of the calibration certificate. Know the instrument's specifications, calibration standards, and the date of calibration, etc. · Comparison with Specifications: Cross-reference the instrument's readings with its specifications to ensure they're still within the required tolerances. · Consider Uncertainty: Take into account the measurement uncertainty provided in the certificate. It helps define the range within which the true value lies. · Update Records: Keep meticulous records of calibration certificates for each instrument. Organized documentation is your best friend during audits and quality assessments. · Trend Analysis: Track the calibration history to identify trends in measurements. Consistent shifts might signal the need for adjustments or maintenance. · Corrective Action: If deviations are observed, swiftly take corrective actions – be it adjustments, repairs, or replacements – to maintain accuracy. · Regular Schedule: Follow a well-defined calibration schedule based on criticality, environment, and recommendations. Regular calibration keeps the ship on course. · Personnel Training: Educate your team on interpreting calibration certificates. Informed decisions are built on a strong foundation of accurate measurements. · Continuous Improvement: Use insights from calibration certificates to continually enhance your measurement processes. Every step towards precision counts! ⏩Remember, accurate measurements are the cornerstone of operational excellence and delivering quality pharmaceuticals. Let's harness the power of calibration certificates to navigate our quality journey with confidence. Like👍, comment🔠, repost🔃 Follow me 👈👈 & ring the 🔔 to get updates on my latest posts. Let's connect and discuss how I can support the implementation of an integrated QMS across the lifecycle to meet all regulatory expectations. #calibration #validation  #pharmaceuticalmanufacturing #qualityassurance #qualification 

GMP REFRESH: Pharmaceutical Technology Transfer - Part II: Planning & Readiness A #transferplan should cover all proposed activities, deliverables and their respective timelines. Technology Transfer Strategy (TTS) The purpose of the #technologytransferstrategy is to clarify the technology transfer in sufficient detail for all the involved functions at the #sendingunit and the #receivingunit to understand the timing, their role and the resource. The TTS should be agreed by both the sending unit and the receiving unit. Process Failure Mode Effect Analysis (#pFMEA) FMEA is used for establish the impact of any potential #failure and to identify and prioritize the action items with the aim of #mitigating any #risks. FMEA is a living document that should be initiated prior to process of production and maintained through the #lifecycle of the product. Bill of Material (#BOM) This is not just a list of the materials that will be used in the process, but also their cost, vendors etc. Comparability protocol #ComparabilityProtocol is a written plan for demonstrating that a product manufactured as part of the technology transfer will be substantially the same as the product produced by the sending unit in terms of strength, quality, purity, and potency. Validation Master Plan (#VMP) The core of the VMP being the list / inventory of the items to be validated and the planning schedule. Cleaning validation plan At this stage a detailed cleaning plan is not necessary, but which parts of the process will use stainless steel / reusable equipment and will thus need cleaning validation and which parts will use “single-use-system” and thus not require cleaning validation should be defined. Material specifications It is important that the exact specifications of the materials used are defined and agreed. #pilotbatches These are also sometimes called #engineeringruns. These are manufacturing runs performed (often under non-GMP conditions) to confirm the #feasibility of the process, #capability of the equipment used, #effectiveness of process parameters and controls. These runs can also be used to confirm the #sampling and #analyticalmethods used as well as being an operator training opportunity and confirmation of procedures and SOPs being used. Control Strategy The #CriticalProcessParameters (CPP) and their values will have been confirmed and these should be detailed in the products #ControlStrategy document and approved by both the sending unit and receiving unit. Readiness review Prior to starting the #PPQbatches, a #readinessreview should be performed in order to demonstrate that all functions have completed their tasks, all documents and protocols are available and approved, all supporting validation & supporting studies have been completed and approved and all preventative maintenance plans are in place. This includes all third party (e.g. outsourced analytical laboratories) as well.

Pharmaceutical Technology transfer flowchart

At DDL,………. Setting up a #pilotplant for pharmaceuticals involves designing a scaled-down version of a production facility to test and develop processes and formulations. It typically includes: 1. Facility Design: Plan the layout, cleanrooms, utilities, and equipment required for pilot-scale operations. 2. Equipment: Select and install equipment like reactors, mixers, filtration systems, and analytical instruments. 3. GMP Compliance: Ensure Good Manufacturing Practices (GMP) are followed to maintain product quality and safety. 4. Process Validation: Validate the manufacturing process to ensure it's reproducible and meets quality standards. 5. Quality Control: Implement a robust quality control system to monitor and analyze product quality. 6. Documentation: Maintain detailed records and documentation of all activities for regulatory compliance. 7. Staff Training: Train personnel on GMP, safety protocols, and the operation of equipment. 8. Regulatory Compliance: Comply with regulatory requirements, and be prepared for inspections. Pilot plants are essential for pharmaceutical companies to optimize production processes and test new formulations before full-scale manufacturing.

👉 Equipment Qualification is a crucial step for any new pharmaceutical plant. An Equipment Qualification (IQ OQ PQ) Protocol is a written plan stating how equipment qualification will be conducted. It details factors such as product characteristics, production equipment, test scripts and methods, test parameters and acceptance criteria, test checksheets, and final approval. The typical objective of a protocol is to prove “fitness for use ” of an equipment system. The high-level goal or purpose of a qualification protocol is to define the test scripts that must be followed to ensure that the equipment is ‘fit for purpose’ to manufacture safe medicines at an affordable cost. The protocol notes all the equipment that you’d test and all the piping and instruments that are connected to the equipment (i.e. the equipment system). It also documents how the tests are going to be carried out, who is going to do them, and records whether the equipment and its piping and instruments pass or fail the test. Determine the Qualification Requirements Most validation projects will take an existing blank template and modify it for the project at hand rather than create a new blank template from scratch every time. But there may be times where you’d need to create key pieces of the protocol from scratch. The protocol will detail the following elements. 🎯  Product characteristics – showing what your system is looking to achieve/produce 🎯 Production equipment – detailing the equipment necessary 🎯  Test scripts and methods – telling you the steps involved in conducting a test 🎯 Test parameters and acceptance criteria – defining acceptable test results 🎯  Test checksheets – documenting and recording the test results 🎯  Final approval – documenting that the validation process has been successfully carried out 👉 The following links describe what an equipment qualification protocol for a Clean-In Place system should contain. https://lnkd.in/gjUuqpEe #iqoqpp #cqv #pharmaceuticalvalidation #riskmanagement #pharmaceuticalmanufacturing #cqvjobs #getreskilled