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MEDVACON has a New Blog Post! Today we take a dive into Key Performance Indicators, or KPIs. What are they? Why are they so important? Quality metrics and KPIs provide valuable insights into the effectiveness of quality systems and processes, enabling you to identify trends and head off problems before they happen. Today’s Post: Part 8 of 10 - 𝐄𝐬𝐭𝐚𝐛𝐥𝐢𝐬𝐡𝐢𝐧𝐠 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐞𝐭𝐫𝐢𝐜𝐬 𝐚𝐧𝐝 𝐊𝐞𝐲 𝐏𝐞𝐫𝐟𝐨𝐫𝐦𝐚𝐧𝐜𝐞 𝐈𝐧𝐝𝐢𝐜𝐚𝐭𝐨𝐫𝐬 (𝐊𝐏𝐈𝐬) “In 2012, with the passage of the Food and Drug Administration Safety and Innovation Act, FDA was given the authority to collect pharmaceutical manufacturing records and information from regulated industry as part of FDA’s risk-based oversight.” Come read the article now! https://lnkd.in/eMSbuvtT #discovery #lifescience #pharma #pharmaceutical #pharmaceuticals #biopharma #biopharmaceuticals #biopharmaceutical #biotech #biotechnology #biotechnologies #biotechindustry #biotechnologyindustry #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharmaceuticalcompanies #pharmaceuticalresearch #pharmaceuticaltechnology #pharmaceuticalpackaging #pharmaceuticalsales #pharmaceuticaljobs #pharmaceuticalinnovation #pharmaceuticalsciences #biotechnologist #compliance #qualitycontrol #computersystemvalidation #cleaningvalidation #processvalidation #dataintegrity #technologytransfer #meddevice #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicemanufacturing #medicaldevicesales #medicaldevicedevelopment #medicaldevicedesign #medicaldeviceresearch #laboratoryequipment #laboratories #laboratorymedicine #laboratoryservices #laboratoryprofessionals #capa #qualification #validationengineer #engineering #engineeringservices #engineeringsolutions #processengineering #processengineer #engineeringdesign #heretohelp #gettingthejobdone #gettingthingsdone 

MEDVACON has a New Blog Post! Today we take a dive into Key Performance Indicators, or KPIs. What are they? Why are they so important? Quality metrics and KPIs provide valuable insights into the effectiveness of quality systems and processes, enabling you to identify trends and head off problems before they happen. Today’s Post: Part 8 of 10 - 𝐄𝐬𝐭𝐚𝐛𝐥𝐢𝐬𝐡𝐢𝐧𝐠 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐞𝐭𝐫𝐢𝐜𝐬 𝐚𝐧𝐝 𝐊𝐞𝐲 𝐏𝐞𝐫𝐟𝐨𝐫𝐦𝐚𝐧𝐜𝐞 𝐈𝐧𝐝𝐢𝐜𝐚𝐭𝐨𝐫𝐬 (𝐊𝐏𝐈𝐬) “In 2012, with the passage of the Food and Drug Administration Safety and Innovation Act, FDA was given the authority to collect pharmaceutical manufacturing records and information from regulated industry as part of FDA’s risk-based oversight.” Come read the article now! https://lnkd.in/eMSbuvtT #discovery #lifescience #pharma #pharmaceutical #pharmaceuticals #biopharma #biopharmaceuticals #biopharmaceutical #biotech #biotechnology #biotechnologies #biotechindustry #biotechnologyindustry #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharmaceuticalcompanies #pharmaceuticalresearch #pharmaceuticaltechnology #pharmaceuticalpackaging #pharmaceuticalsales #pharmaceuticaljobs #pharmaceuticalinnovation #pharmaceuticalsciences #biotechnologist #compliance #qualitycontrol #computersystemvalidation #cleaningvalidation #processvalidation #dataintegrity #technologytransfer #meddevice #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicemanufacturing #medicaldevicesales #medicaldevicedevelopment #medicaldevicedesign #medicaldeviceresearch #laboratoryequipment #laboratories #laboratorymedicine #laboratoryservices #laboratoryprofessionals #capa #qualification #validationengineer #engineering #engineeringservices #engineeringsolutions #processengineering #processengineer #engineeringdesign #heretohelp #gettingthejobdone #gettingthingsdone 

Basic Rules of GMP: The Good Manufacturing Practices (GMP) regulations in the pharmaceutical industry, as outlined in 21 CFR (Code of Federal Regulations) Part 211, establish basic rules to ensure the quality, safety, and efficacy of pharmaceutical products. Here are some key points from these regulations: Quality Control: Manufacturers must establish and maintain a robust quality control system to ensure products consistently meet their specifications and quality standards. Personnel: Employees involved in manufacturing, processing, packaging, and holding of drugs should have the necessary qualifications, training, and experience. Facilities and Equipment: Adequate facilities and equipment should be used to manufacture, process, pack, and store drugs. These facilities must be designed to prevent contamination and cross-contamination. Control of Components and Drug Product Containers/Closures: Raw materials and components used in manufacturing should be tested and verified for their identity, strength, quality, and purity. Containers and closures should also be controlled to prevent contamination. Production and Process Controls: Manufacturing processes should be well-defined, documented, and controlled to ensure consistent product quality. Critical steps in the manufacturing process should be validated. Packaging and Labeling Control: Proper controls should be in place for labeling and packaging materials. Labels should accurately represent the contents of the product. Holding and Distribution: Drugs should be held and stored under appropriate conditions to prevent deterioration or contamination. Distribution should be controlled to prevent mix-ups and errors. Laboratory Controls: Quality control laboratories should be equipped and staffed to perform testing and analysis to ensure product quality and compliance. Records and Reports: Accurate and complete records should be maintained for all aspects of production, testing, and distribution. These records should be retained for a specified period. Complaints: Procedures should be in place to handle and investigate complaints related to product quality and safety. Out-of-Specification Results: If any batch of drug product fails to meet specifications, it should not be released for distribution until an investigation is conducted. Validation: Processes, equipment, and systems critical to product quality should be validated to ensure consistency and reliability. Quality Audits: Regular internal and external audits should be conducted to ensure compliance with GMP regulations. These are just some of the fundamental rules outlined in 21 CFR Part 211. Adhering to these regulations helps ensure that pharmaceutical products are manufactured in a consistent and controlled manner, leading to products that are safe, effective, and of high qualiity.

GMP REFRESH: Hold time Management in Pharma Manufacturing- Part II Manufacturers should ensure that the products are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to #validatedprocesses and to defined procedures. #Manufacturingprocesses should be shown to be capable of consistently manufacturing pharmaceutical products that are of the required quality and that comply with their specifications. #GMP require that arrangements should be made to ensure that the dispensed raw materials and packaging materials, intermediate products, bulk and finished products are stored under appropriate conditions. Storage arrangements should not have deleterious effects on starting materials, intermediate products and bulk products prior to final packing. #Maximumacceptableholdingperiods should therefore be established to ensure that intermediates and #bulkproduct can be held, pending the next processing step, without producing results outside the acceptance criteria for the quality of the material. Normally, #intermediate and bulk products should not be stored beyond the established hold time. The choice of maximum holding period should be supported by relevant data. Hold-Time Studies #Holdtimestudies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not produce results outside the acceptance criteria during the hold time. The design of the study should reflect the holding time at each stage. Justification of Time-Limit Deviation How can minor or gross deviation from the specified time limit be justified when the time limit selected is somewhat arbitrary? Why would holding a bulk biopharmaceutical drug substance for 24 hours be allowable but 25 hours would not? Is repeating a process step a reasonable response to exceeding the time limitation? Avoidance of Holding In-Process Materials Many strategies are being implemented to avoid the holding of in-process material. The drivers are controlling risk, lowering manufacturing costs and shortening the manufacturing, time and decreasing in-process intermediate inventories, work-in-progress and prevent potential back orders. These strategies include continuous manufacturing, clean- and sterilize-in-place, and continuous sterile filtration and aseptic filling. Reliability Is the application of reliability tools a useful approach? #reliability is “the probability that a product, system, or service will perform its intended function adequately for a specified period of time, or will operate in a defined environment without failure”. Although stochastic parameters may define and affect reliability, multivariate inputs with wide ranges of uncertainty largely invalidate quantitative methods of reliability, especially as applied to #pharmaceuticaldrugproducts. If you like this post follow me on LinkedIn

Correcting the Most Common Causes of #Pharma Process #Deviations, https://lnkd.in/dd4THByu 💡 Tip: Manage deviations with the pharmaceutical BPAQuality365® https://lnkd.in/ejeCdA4a , it benefit companies in the pharmaceutical sector by supporting #quality management, document control, #compliance management, #risk management, training and competency management, and #change control processes, https://lnkd.in/ejeCdA4a Using tools and processes designed to identify and overcome process deviations can help you keep all your product production processes in compliance, https://lnkd.in/dd4THByu BPAQuality365® https://lnkd.in/ejeCdA4a supports #pharmaceutical companies in adhering to strict regulatory requirements. It helps document and manage compliance processes, including regulatory #audits and #inspections. The software assists in maintaining compliance with industry standards and regulations such as Good Manufacturing Practices (#GMP) and Good Laboratory Practices (#GLP). This ensures regulatory compliance, reduces risk, and strengthens the company’s reputation, https://lnkd.in/ejeCdA4a #regulatoryaffairs #bpa #excellence #medical

“Quality management is important in every business, but it is critical to the pharmaceutical industry.” Read more about QMS in the following article: https://lnkd.in/d9xyi7Me While on the subject you can also check our Good Laboratory Practice online course: https://lnkd.in/eXnjXHnF #pharmalessons #glp #training #courses #qms

Good Manufacturing Practice (GMP) in the Pharmaceutical Industry **Quality Assurance**: GMP ensures that pharmaceutical products are consistently produced and controlled to meet quality standards, reducing the risks of contamination, mix-ups, and errors. **Compliance Requirements**: Adhering to GMP regulations is essential for obtaining marketing authorization and ensuring the safety and efficacy of pharmaceutical products. **Regulatory Oversight**: GMP guidelines are enforced by regulatory authorities to maintain the integrity of the pharmaceutical supply chain and protect public health Key Elements of GMP Compliance **Facility Standards**: GMP requires pharmaceutical facilities to maintain proper cleanliness, sanitation, and environmental controls to prevent cross-contamination and ensure product safety. **Documentation and Record-Keeping**: Accurate and comprehensive documentation of manufacturing processes, testing, and quality control measures is crucial for GMP compliance. **Personnel Training and Hygiene**: GMP mandates training programs for employees to ensure proper handling of materials, equipment, and adherence to hygiene standards. GMP and Product Quality **Consistency and Uniformity**: GMP practices aim to ensure that each pharmaceutical product meets the required quality standards and specifications. **Risk Mitigation**: GMP helps in identifying and mitigating potential risks associated with the manufacturing, packaging, and distribution of pharmaceutical products. **Continuous Improvement**: GMP encourages the implementation of quality management systems to drive ongoing improvements in product quality and manufacturing processes.

🔬 In the pharmaceutical industry, Quality Control (QC) and Quality Assurance (QA) are two critical aspects of quality management. They ensure that medications are manufactured correctly, safe to use, and have the desired effect. 📊 QA is a systematic approach that ensures quality throughout a product’s lifecycle. It starts with well-defined and documented development processes, providing a foundation for consistent, high-quality outcomes. QA establishes standards and guidelines, serving as benchmarks for expected quality levels. It focuses on defect prevention by identifying and mitigating potential risks early in the process. 🔎 On the other hand, QC involves inspecting and testing the final product against predetermined criteria to identify and correct deviations from quality standards. Immediate corrective actions are taken during QC to rectify defects, and detailed documentation of inspection results is kept for record-keeping. 🔁 The key difference between QC and QA lies in their purpose and objectives. While QA sets the standards and processes to prevent defects, QC checks the final output to ensure it meets those established standards. Read our blog "QC vs QC in a Pharmaceutical Setting" here --> https://vist.ly/3bk8c #QualityControl #QualityAssurance #Pharmaceuticals #QualityManagement

Quality Metrics for Drug Manufacturing:: What are Quality Metrics? For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data may lead to higher levels of safety, efficacy, delivery, and performance. Quality metrics are used throughout the drug and biological product industry to monitor processes and drive continuous improvement efforts in manufacturing. Effective use of quality metrics is one characteristic of robust site Quality Management Maturity (QMM). Why are Quality Metrics Important? The minimum standard for ensuring that a manufacturer’s products are safe, effective & of sufficient quality is compliance with current good manufacturing practice (CGMP) requirements. CGMP compliance alone, however, does not indicate whether a Mfr. is investing in improvements and striving for sustainable compliance, which is the state of having consistent control over manufacturing performance and quality. Sustainable compliance is difficult to achieve without a focus on continual improvement. An effective Pharmaceutical Quality System (PQS) ensures both sustainable compliance and supply chain robustness. Quality metrics can contribute to a mfr’s ability to develop effective PQS because these data provide insight into mfg. performance & enable identification of opportunities for updates & innovation to mfg. practices. Quality metrics also play an important role in supplier selection and can inform the oversight of contract activities and material suppliers, as well as help determine appropriate monitoring activities to minimize supply chain disruptions. Quality metrics data from establishments can also have utility to the FDA. Assist in developing compliance and inspection policies and practices. Improve prediction and possibly mitigation of future drug shortages, while encouraging the pharmaceutical industry to implement innovative quality management systems for manufacturing. Enhance FDA’s risk-based inspection scheduling, reducing the frequency and/or length of routine surveillance inspections for establishments with quality metrics that suggest sustainable compliance. Provide ongoing insight into an establishment’s operations between inspections. How Can Quality Metrics be used at FDA? As part of FDA’s ongoing adoption of risk-based regulatory approaches, agency is proposing to develop and implement a Quality Metrics Reporting Program to support its quality surveillance activities. Under this program, the FDA intends to analyze the quality metrics data submitted by establishments to: obtain a more quantitative and objective measure of manufacturing quality and reliability at an establishment; integrate metrics n resulting analysis into FDA’s comprehensive quality surveillance program n apply the results of the analysis to assist in identifying products at risk for quality problems (e.g., quality-related shortages and recalls).

“Quality management is important in every business, but it is critical to the pharmaceutical industry.” Read more about QMS in the following article: https://lnkd.in/d9xyi7Me While on the subject you can also check our Good Laboratory Practice online course: https://lnkd.in/eXnjXHnF #pharmalessons #glp #training #courses #qms