GMP Insiders’ Post

ICH guidelines for the validation of "Particle Size Measurement" #Validation #analyticalvalidation #particlesizemeasurement #qualityassurance #QA #qualitycontrol #qc #pharmaceuticalindustry #ich #USP

Why do we document? 📚 Good documentation practices (#GDP) are essential for maintaining a clear, objective record of actions and decisions. They act as a critical source of evidence, allowing us to confidently respond "yes" when asked "Did it happen?" by QA supervisors or during audits. However, their true value lies not just in proving an action occurred, but in providing thorough details about how and why it happened, offering valuable context for troubleshooting, learning, and informed decision-making. 💥 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭 𝐜𝐨𝐧𝐭𝐫𝐨𝐥𝐬 and its requirement are important. You must establish and maintain procedures to control all documents as required by the quality system regulation. The procedures shall ensure proper approval, controlled distribution, and a structured change management process for all versions.    💥 𝐂𝐡𝐚𝐧𝐠𝐞𝐬 to documents require review and approval by individuals from the same function or organization that performed the original approval unless specifically noted otherwise. Document changes must describe the change, identify the affected documents, have signatures of the approving individuals, the approval date, and date on which the change becomes effective. Changes must be communicated to appropriate personnel in a timely manner. It is important that the right people approve changes, and everyone affected knows about them. 💥 𝐑𝐞𝐜𝐨𝐫𝐝𝐬 required by the quality system regulation must be located at the manufacturing site or a location reasonably accessible to the manufacturer. All records must be legible and stored to minimize deterioration and prevent loss. Any records stored in an automated data processing system, electronically, must be backed up. What challenges are you facing in your daily work to comply or make others comply with these requirements❓ #regulatorycompliance #qualitysystem #gooddocumentationpractice #medicaldevices #510k #pharmaceutical #FDA #qa

Do you want to start a career as a Quality Assurance Specialist in Pharma? Well, in the world of Pharma, Quality Assurance (QA) is not just a role, but a mission. It's the silent guardian of health and safety, ensuring every medication we trust is up to the mark. 🛡️💊 QA in Pharma is where precision meets care. It's about maintaining the highest standards in every pill and potion. From rigorous processes to meticulous documentation, QA professionals are the unsung heroes behind every successful product. 🌟🔬 Discover the significance of QA in Pharma 📚 🔗www.pharmuni.com #QualityAssurance #PharmaHeroes #HealthcareSafety #PharmaceuticalQuality

We know very well, the critical role that a Quality Assurance Specialist plays in the world of #pharma. I have seen first hand the difference a good QA specialist can make and I have also seen some not so great examples. That is why all of our QA team go through a rigorous onboarding, complete the Pharmuni #qualifications for the QA specialist and receive regular upskilling. Just as we believe in the power of knowledge as a key driver to success, the QA leadership and Management team at Zamann Pharma Support also believe education and support to be foundations for growing your teams and developing them into experts. #educate #developers #nurture #qualityassurance #pharma

Deviation:- Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure. A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing. Purpose:- To Lay down a procedure to identify document, Investigate and determine root causes of all types of Deviation/Failure related to product or systems. In addition to ensure that product Quality, Safety and Purity is maintain and cGMP/Regulatory requirements and Regulatory Guidelines are met. Deviation or Failure Handling Procedure:- The Deviation/Failures will be evaluated using risk Management approach and the batches impacted will be released after closing deviation. Following Sequence will be adopted:- 1)Identification or Detection of Deviation or Failure. 2)Deviation/Failure Report. 3)Initial Risk Assessment & Classification of Deviation/Failure. 4)Failure Investigation:- *Investigation Purpose. *Investigation Strategy. *Conducting Investigation. *Investigation Report & Deviation/Failure Final Decision. *Closure of Deviation/Failure. *Tracking & Trending. *Deviation/Failure Investigation Report Arching. Minor:- *No impact on Product Quality. *CCP not Involved. *No Impact on GXP. *Immediate Action. *Record in BMR/BPR. *No Risk Assessment Required. *No Failure Investigation Required. *Close. Major:- *Potentially Impacts Product. *Potentially Impacts Certificate of Pharmacutical Product (CCP). *Potentially Impacts GXP. *Immediate Action. *Record in BMR/BPR. *Risk Assessment *Failure Investigation * Root Cause Analysis. *CAPA. *Close. Critical:- *Product Impacted. *Regulatory Compliance Impacted. *Record in BMR/BPR. *Risk Assessment. *Failure Investigation *Root Cause Analysis *CAPA. *Batch Disposition. *Close. Assigning of Deviation Report Number:- DEV= Deviation QA= Quality Assurance=Department XX= Year=2023 XXX= Deviation Number=000 Example of Deviation Number= DEV-QA-23-001 Fish Bone Diagram (Shikawi Diagram):- People:- *Technical Know How. *GXP Rules Know How. *Safety Rules Know How. *Training. *Medical Attitude. *Number Involved. *Attitude to Work. *Discipline. Machine:- *Condition. *Calibration. *Qualification. *Maintenance *Instrumentation *Utilities-Compressed Air System, Steam, Water & Electricity. Environment:- *Workplace Temperature & Humidity. *Workplace Noise & Light Level. *Working Atmosphere. *Workspace. Material/Process/Product:- *Raw Materials plus water. *Packaging Materials. *Manufacturing Process. *Packaging Process. *Semi Finished Product Testing. *Finished Product Testing. *Storage *Distribution Documents:- *Instructions of Manufacturing. *Instructions of Packaging. *Instructions for use of Equipment. *Analytical Methods. *Relevant SOPs. *Training on SOPs. Conclusion:- *People *Machine *Environment *Documents *Product/Material/Process.

Deviation:- Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure. A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing. Purpose:- To Lay down a procedure to identify document, Investigate and determine root causes of all types of Deviation/Failure related to product or systems. In addition to ensure that product Quality, Safety and Purity is maintain and cGMP/Regulatory requirements and Regulatory Guidelines are met. Deviation or Failure Handling Procedure:- The Deviation/Failures will be evaluated using risk Management approach and the batches impacted will be released after closing deviation. Following Sequence will be adopted:- 1)Identification or Detection of Deviation or Failure. 2)Deviation/Failure Report. 3)Initial Risk Assessment & Classification of Deviation/Failure. 4)Failure Investigation:- *Investigation Purpose. *Investigation Strategy. *Conducting Investigation. *Investigation Report & Deviation/Failure Final Decision. *Closure of Deviation/Failure. *Tracking & Trending. *Deviation/Failure Investigation Report Arching. Minor:- *No impact on Product Quality. *CCP not Involved. *No Impact on GXP. *Immediate Action. *Record in BMR/BPR. *No Risk Assessment Required. *No Failure Investigation Required. *Close. Major:- *Potentially Impacts Product. *Potentially Impacts Certificate of Pharmacutical Product (CCP). *Potentially Impacts GXP. *Immediate Action. *Record in BMR/BPR. *Risk Assessment *Failure Investigation * Root Cause Analysis. *CAPA. *Close. Critical:- *Product Impacted. *Regulatory Compliance Impacted. *Record in BMR/BPR. *Risk Assessment. *Failure Investigation *Root Cause Analysis *CAPA. *Batch Disposition. *Close. Assigning of Deviation Report Number:- DEV= Deviation QA= Quality Assurance=Department XX= Year=2023 XXX= Deviation Number=000 Example of Deviation Number= DEV-QA-23-001 Fish Bone Diagram (Shikawi Diagram):- People:- *Technical Know How. *GXP Rules Know How. *Safety Rules Know How. *Training. *Medical Attitude. *Number Involved. *Attitude to Work. *Discipline. Machine:- *Condition. *Calibration. *Qualification. *Maintenance *Instrumentation *Utilities-Compressed Air System, Steam, Water & Electricity. Environment:- *Workplace Temperature & Humidity. *Workplace Noise & Light Level. *Working Atmosphere. *Workspace. Material/Process/Product:- *Raw Materials plus water. *Packaging Materials. *Manufacturing Process. *Packaging Process. *Semi Finished Product Testing. *Finished Product Testing. *Storage *Distribution Documents:- *Instructions of Manufacturing. *Instructions of Packaging. *Instructions for use of Equipment. *Analytical Methods. *Relevant SOPs. *Training on SOPs. Conclusion:- *People *Machine *Environment *Documents *Product/Material/Process. #qa #qc #managers #deviation #validation #jobs

Deviation:- Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure. A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing. Purpose:- To Lay down a procedure to identify document, Investigate and determine root causes of all types of Deviation/Failure related to product or systems. In addition to ensure that product Quality, Safety and Purity is maintain and cGMP/Regulatory requirements and Regulatory Guidelines are met. Deviation or Failure Handling Procedure:- The Deviation/Failures will be evaluated using risk Management approach and the batches impacted will be released after closing deviation. Following Sequence will be adopted:- 1)Identification or Detection of Deviation or Failure. 2)Deviation/Failure Report. 3)Initial Risk Assessment & Classification of Deviation/Failure. 4)Failure Investigation:- *Investigation Purpose. *Investigation Strategy. *Conducting Investigation. *Investigation Report & Deviation/Failure Final Decision. *Closure of Deviation/Failure. *Tracking & Trending. *Deviation/Failure Investigation Report Arching. Minor:- *No impact on Product Quality. *CCP not Involved. *No Impact on GXP. *Immediate Action. *Record in BMR/BPR. *No Risk Assessment Required. *No Failure Investigation Required. *Close. Major:- *Potentially Impacts Product. *Potentially Impacts Certificate of Pharmacutical Product (CCP). *Potentially Impacts GXP. *Immediate Action. *Record in BMR/BPR. *Risk Assessment *Failure Investigation * Root Cause Analysis. *CAPA. *Close. Critical:- *Product Impacted. *Regulatory Compliance Impacted. *Record in BMR/BPR. *Risk Assessment. *Failure Investigation *Root Cause Analysis *CAPA. *Batch Disposition. *Close. Assigning of Deviation Report Number:- DEV= Deviation QA= Quality Assurance=Department XX= Year=2023 XXX= Deviation Number=000 Example of Deviation Number= DEV-QA-23-001 Fish Bone Diagram (Shikawi Diagram):- People:- *Technical Know How. *GXP Rules Know How. *Safety Rules Know How. *Training. *Medical Attitude. *Number Involved. *Attitude to Work. *Discipline. Machine:- *Condition. *Calibration. *Qualification. *Maintenance *Instrumentation *Utilities-Compressed Air System, Steam, Water & Electricity. Environment:- *Workplace Temperature & Humidity. *Workplace Noise & Light Level. *Working Atmosphere. *Workspace. Material/Process/Product:- *Raw Materials plus water. *Packaging Materials. *Manufacturing Process. *Packaging Process. *Semi Finished Product Testing. *Finished Product Testing. *Storage *Distribution Documents:- *Instructions of Manufacturing. *Instructions of Packaging. *Instructions for use of Equipment. *Analytical Methods. *Relevant SOPs. *Training on SOPs. Conclusion:- *People *Machine *Environment *Documents *Product/Material/Process.

Quality assurance in the pharmaceutical industry is more than just a job - it is a 100% commitment to quality.