How to run operations as if the FDA is always inpecting. | Marc Kernodle posted on the topic | LinkedIn (2024)

⌚ In recent years, the CGMP manufacturing industry has experienced a significant shift in FDA inspection dynamics. At the height of the pandemic in FY2021, FDA conducted 7,147 onsite domestic inspections and 186 foreign inspections. In FY 2022, this grew to 12,203 domestic and 907 foreign inspections, and in FY 2023, increased to 13,305 domestic inspections and 2,716 foreign inspections. The COVID-19 pandemic and the subsequent increase in remote work resulted in a lull in on-site FDA inspections. While this has offered some breathing room, it's crucial to remember that inspection readiness is not a one-time event but a continuous state of preparedness. As manufacturing sites start to see a resurgence of in-person inspections, staying ready is more important than ever. 🤔 So what does it mean to be "inspection ready" at all times? It implies that the facility maintains a CONSISTENT state of compliance with all regulatory requirements, quality standards, and internal processes. Essentially, you are prepared to undergo an FDA inspection without the need for last-minute adjustments or panic. Here are 3 simple strategies to help:*Regular Internal Audits: Conducting regular internal audits can help identify potential issues before the FDA does. These audits should be thorough and mimic FDA inspections to ensure nothing is overlooked. Include individuals from level 1 operators to senior leadership.*Robust Documentation Practices: Ensure all records are up-to-date and easily accessible. Good documentation practices are the backbone of inspection readiness, providing clear evidence of compliance. Some of the commonly requested documents include, but are not limited to the following: Site Master File, Organization Chart (up to Operator or Analyst level), SOP Master Index, List of products, Training procedure, Recall procedure, Batch numbering procedure, List of deviations, change controls, OOS, complaints investigations and CAPAs since the last inspection, Responses and CAPAs to prior FDA 483 Observations*Training and Education: Continuous training for all staff members on current regulations and best practices is essential. This not only keeps everyone informed but also instills a culture of quality and compliance.What are some of your strategies to stay "inspection ready?"#manufacturing #fda #inspectionreadiness

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Compliance isn't just a checkbox! Be a part of our 2-Day Seminar by Expert John E. Lincoln to discover 7 critical cGMP systems and the 4 key focus areas to stay ahead and meet FDA standards effortlessly. https://lnkd.in/dJMZRsUT#Webinar #Seminar #FDACompliance #MedicalDevices #compliancetrainings #regulatorycompliance #audits #cGMP #21cfr #QSIT

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Discover the crucial role of #gmp audits in upholding safety and quality standards across the pharmaceutical industry.From facility cleanliness to #documentation accuracy, GMP audits leave no stone unturned.🏭 Dive into the multifaceted audit process, from on-site inspections to documentation reviews 👉🏼https://lnkd.in/dtiT4Emq andLearn how GMP audits safeguard public health by minimizing #risks Explore ZENOVEL's unique contributions to successful 3rd-party GMP audits:▪️ Unbiased assessments for credibility▪️ Vast industry #experience for expert insights▪️ Specialized knowledge for comprehensive evaluations▪️ #tailoredsolutions to meet unique client needsIn industries where product quality is paramount, GMP audits ensure #compliance and consumer trust.ZENOVEL's approach adds value by going beyond compliance, helping manufacturers enhance their processes. Get in touch with us now!#GMPAudits #QualityAssurance #ComplianceMatters #Zenovel

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ISO 9001 and cGMP ISO 9001 is an international standard that sets out the criteria for a quality management system (QMS). It is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to their products or services. ISO 9001 provides a framework for organizations to establish, implement, maintain, and continually improve their quality management systems.Similarities between ISO 9001 and cGMP (Current Good Manufacturing Practices):1. Quality Focus: Both ISO 9001 and cGMP emphasize the importance of maintaining high-quality standards in manufacturing processes to ensure that products are safe, effective, and meet customer requirements.2. Documentation and Record-Keeping: Both ISO 9001 and cGMP require thorough documentation of processes, procedures, and quality records to ensure traceability and compliance with standards.3. Continuous Improvement: Both ISO 9001 and cGMP promote the concept of continuous improvement through the use of data-driven decision-making, corrective and preventive actions, and ongoing monitoring of processes.Implementing ISO 9001 in a manufacturing company involves several key steps:1. Leadership Commitment: Top management must demonstrate leadership and commitment to implementing and maintaining the QMS.2. Establishing a Quality Policy: The organization should define its quality policy, outlining its commitment to meeting customer requirements and complying with relevant regulations.3. Identifying Processes: The company should identify key processes and interactions within the organization and determine how they contribute to meeting quality objectives.4. Documentation: Develop and maintain documented information that defines the QMS processes, procedures, and work instructions.5. Training and Awareness: Ensure that employees are trained in the requirements of ISO 9001 and understand their roles in implementing the QMS.Creating documents for ISO 9001 involves several key considerations:1. Document Control: Establish a document control procedure to ensure that documents are approved, reviewed, updated, and accessible to relevant personnel.2. Process Mapping: Use process mapping techniques to identify key processes and their interactions within the organization.3. Work Instructions: Develop clear, concise work instructions that detail how specific tasks or activities should be performed to meet quality requirements.4. Quality Records: Establish procedures for creating, maintaining, and retaining quality records to demonstrate compliance with ISO 9001 requirements.When creating documents for ISO 9001, it's important to ensure that they are clear, concise, and aligned with the organization's quality objectives. Documents should be regularly reviewed and updated as necessary to reflect changes in processes or requirements. Additionally, #cdmo #pharmaceuticalindustry #pharmaindustry #pharma

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Supplier AuditingWe perform both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management programme. In addition, investigative audits following process concerns are also undertaken.We perform API and finished products manufacturers’ audit to check compliance with ICH,EU-GMP,US FDA ,WHO-GMP etc.#auditing #supplierAuditing #compliance

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GMP COMPLIANCE: Establishing a Culture of Inspection ReadinessPart II - FDA inspections #InspectionReadiness (IR) is a process of preparing for an inspection by a #regulatoryauthority such as the FDA. The #FDA conducts official reviews of documents, facilities, records, and any other resources they deem to be related to the clinical trial, manufacturing, and operations. Every pharma company is responsible for inspection readiness by providing #training to employees and ensuring their understanding and application of policies, standards, and procedures. Pharma organizations should allocate the resources to assure that inspection readiness teams are in place to manage activities before, during, and after inspections.FDA performs four different types of inspections at many different types of facilities, and your company’s response should be tailored to the specific type of event. FDA’s inspection authority also extends to #foreignmanufacturing and #processingsites for FDA-regulated products sold in the United States. Fall within these bounds, and you can anticipate an FDA inspection at your facility.The four different types of inspections conducted by FDA are pre-approval inspection, routine inspection, compliance follow-up inspection, “for cause” inspection. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.#PreApprovalInspections (PAI) are conducted after a company submits an application to FDA to market a new product. These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product. The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval.#RoutineInspections are mandated by law every 2 years for class II and class III device manufacturers. They follow a prescribed method known as #QualitySystemInspectionTechnique (QSIT). If a serious public health risk is identified during a routine inspection, the inspection type may then switch to a #forcauseinspection.#ComplianceFollowUpInspections review actions taken by a firm/manufacturer in response to a previous inspection that resulted in significant 483 observations or a #WarningLetter. “For Cause” Inspections investigate a specific problem that has been reported to FDA. The source of the report can be the manufacturer, consumer/user complaints, or even a disgruntled employee. This inspection usually is initiated at the request of CDRH, ORA, or regional directive. These inspections typically are more in-depth than routine inspections, and they may not follow a QSIT approach.FDA’s Guide to Inspections of Quality Systems describes the process in greater detail.https://lnkd.in/euqAst5HRegardless of the type of inspection, it is up to you to always be prepared for FDA to visit your facility. #FDA #ispections #readiness

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US 21 CFR Part 11 and EU GMP Annex 11📜💻 Let's dive into a simplified comparison table that outlines the key features and requirements of each regulation:🔀 Scope:US 21 CFR Part 11 ➡ Applies to all FDA regulated industries. 🇺🇸EU GMP Annex 11 ➡ Applies to the pharmaceutical industry in the European Union. 🇪🇺🎯 Objective:US 21 CFR Part 11 ➡ To define the criteria for electronic records and electronic signatures.EU GMP Annex 11 ➡ To define the criteria for computerized systems used in the manufacture of pharmaceutical products.💾 Electronic Records:US 21 CFR Part 11 ➡ Defines requirements for electronic records' reliability, integrity, and security.EU GMP Annex 11 ➡ Specifies requirements for controlling computerized systems' design.✍️ Electronic Signatures:US 21 CFR Part 11 ➡ Defines requirements for equivalent electronic signatures.EU GMP Annex 11 ➡ Focuses on data integrity and security, not specifically addressing electronic signatures.💯 Validation:US 21 CFR Part 11 ➡ Requires system validation for accuracy, reliability, and consistent performance.EU GMP Annex 11 ➡ Requires validation of computerized systems for data integrity and traceability.⏰ Audit Trails:US 21 CFR Part 11 ➡ Uses secure, time-stamped audit trails to track changes.EU GMP Annex94issem*nt Avec La Reforme De Modernisation Hospitaliere194➡ Requires audit trails recording all relevant changes when it comes to Good Manufacturing Practices (GMP).👩🏫 Training:US 21 CFR Part 11 ➡ Requires educated, trained, and experienced personnel.EU GMP Annex 11 ➡ Demands trained personnel for tasks performance.💾 Data Backup:US 21 CFR Part 11 ➡ Protects and retrieves records when needed.EU GMP Annex 11 ➡ Mandates backed up data in a usable format for official checks.📝 Documentation:US 21 CFR Part 11 ➡ Establishes written policies holding individuals accountable for actions under their electronic signatures.EU GMP Annex 11 ➡ Emphasizes clear documentation impacting product quality.🔐 System Access:US 21 CFR Part 11 ➡ Limited access restricted to authorized individuals only.EU GMP Annex 11 ➡ Prevents unauthorized alterations by limiting system access to authorized users.This table offers a high-level comparison between the two regulations. Although there are similarities, each regulation brings its own unique features and focus areas. 💼To ensure compliance, it is crucial to explore and grasp the specific requirements of each regulation. 📚US 21 CFR Part 11: CFR - Code of Federal Regulations Title 21 (fda.gov)EU GMP Annex 11: Annex 11 Final 0910 (europa.eu) #gmp #compliancematters #usa #eu #21cfrpart11 #validation #dataintegrity #gmp #regulatoryaffairs #regulatory #knowledgesharing #learning Regulatory Affairs Professionals Society (RAPS) #kaust #mhra #europeanunion

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How to develop &manage robust Quality Matrix?··Developing &managing a robust Quality Matrix to meet regulatory requirementsrequires careful attention to detail, adherence to stringent standards, and a focus on patient safety. Here's a tailored guide for the same:1. Understand Regulatory Landscapes:Familiarize yourself with regulatory bodies governing the pharmaceutical industry such as the US FDA , EMA (in Europe), and other regional regulatory authorities. Understand relevant regulations and guidelines such as GMP, GCP, and GLP.2. Identify Critical Quality Metrics:Determine key quality metrics specific to the pharma industry. These may include product quality attributes, manufacturing process parameters, compliance with pharmacopeial standards, adverse event reporting, and adherence to regulatory submission timelines.3. Define Quality Objectives:Establish quality objectives aligned with regulatory requirements. Objectives should focus on ensuring product efficacy, safety, and compliance with regulatory standards. 4. Create a Quality Matrix Framework:Develop a structured Quality Matrix framework. Include sections for critical quality attributes, manufacturing processes, analytical methods, documentation requirements & regulatory compliance. Ensure clarity on roles, responsibilities & escalation procedures.5. Implement Risk-Based Approach:Utilize a risk-based approach to prioritize quality activities & allocate resources effectively. Identify high-risk areas in the product lifecycle such as formulation development, manufacturing, packaging & distribution. Focus quality efforts on mitigating risks.6. Utilize QMS:Implement a robust QMS to manage documentation, deviations, CAPA, change controls & other quality-related processes. Ensure the QMS complies with regulatory requirements & facilitates traceability & accountability.7. Ensure Supplier Quality Management:Establish procedures for evaluating & monitoring the quality of raw materials,APIs, and third-party suppliers. Conduct supplier audits, qualification assessments & ongoing monitoring to ensure compliance with regulatory standards & product quality requirements.8. Implement Validation & Qualification:Validate critical processes, equipment, analytical methods & computer systems in accordance with regulatory guidelines such as ICH Q7, Q8, Q9, and Q10. Ensure thorough documentation to demonstrate compliance with regulatory requirements.9. Maintain Data Integrity:Implement measures to ensure the integrity, accuracy, and reliability of data generated throughout the product lifecycle. Adhere to principles of ALCOA + &implement controls to prevent data manipulation or falsification.10. Conduct Regulatory Compliance Audits:Regularly conduct internal audits to assess compliance with regulatory requirements, quality standards & established procedures. By following these tailored steps, you can develop & manage a robust Quality Matrix.#qualitymatrix #compliance

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DataIntegrity most important Guidlines💡💡💡💫💫💫➖➖➖1. #FDA Guidance for Industry: Data Integrity and Compliance with #cGMP2. #MHRA #GXP Data Integrity Guidance and Definitions3. #WHO Technical Report Series No. 996, Annex 5: Guidance on Good Data and Record Management Practices4. PIC/S PI 041-1: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments5. #EMA Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in #Clinical Trials6. #ISPE Good Practice Guide: Records and Data Integrity7. #PDA Technical Report No. 82: Data Integrity in #Laboratory Systems8. USP General Chapter <1058> Analytical Instrument #Qualification and <1210> Statistical Tools for Procedure Validation9. #ICH Q10 Pharmaceutical Quality System, Section 2.5 on Management Responsibility for Quality and Section 6 on Continual Improvement of Process Performance and Product Quality.10. ISO/IEC 27001 Information Security Management System Standard, Section A12 on Information Security Incident #Management➖➖➖Join to #Pharmatalks #Telegram channel and groupt.me/pharmatalksTo join you can also search @Pharmatalks in Telegram search section

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Our 2024 "Compliance Issue" is now available for paid subscribers to our Insider Newsletter.In this special 90-minute deep dive, we examine the top-cited CGMP CFRs in the drug and device spaces from FDA's FY2023, identifying trends and offering practical insights for proactive compliance assurance in the problem areas FDA is most often seeing and citing.Here’s a quick top-line look at the FY2023 numbers in each space, as gathered from the FDA’s Data Dashboard:𝐃𝐫𝐮𝐠 𝐂𝐆𝐌𝐏:———1. — 21 CFR 211.192 - Recordkeeping - 98 citations2. —21 CFR 211.22(d) - Quality Control Unit Responsibilities - 93 citations3. — 21 CFR 211.100(a) - Production and Process Controls - 60 citations4. — 21 CFR 211.160(b) - Laboratory Controls - 48 citations5. —21 CFR 211.68(b) - Equipment Cleaning and Maintenance - 47 citations𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐆𝐌𝐏:———1. — 21 CFR 820.100(a): Corrective and Preventive Action - 190 citations2. — 21 CFR 820.198(a): Complaint Handling Procedures - 164 citations3. — 21 CFR 820.184: Device History Record (DHR) Procedures - 85 citations4. —21 CFR 820.22: Quality Audit Procedures - 84 citations5. — 21 CFR 820.90(a): Nonconforming Product Control - 83 citationsIn addition to dissecting these trending problem areas, we offer lengthy checklists for self-assessment on some of the acute indicators we see most often in the field.For example, in the pharma space:• Is there a documented process for logging all discrepancies and failures, regardless of their immediate perceived impact?•Are investigations conducted for all discrepancies and failures to identify root causes?• Does the documentation for each discrepancy include a detailed investigation report and the implementation of corrective and preventive actions?• Is there a mechanism to ensure that lessons learned from discrepancies are integrated into operational practices?And in the device space:• Does the CAPA process include provisions for escalating issues that require management attention?• Are employees across relevant departments trained on the CAPA process and their specific responsibilities?• Is there a system for tracking audit findings to closure, including verification of implemented corrective actions?• Is there a clear process for reviewing and approving the disposition of nonconforming products, including rework, scrap, or return to the supplier?🔗 Paid subscribers can watch and read our entire breakdown along with the slide decks: https://lnkd.in/ghYeHXk5———Need compliance assistance? Contact us for auditing/mock inspection and remediation support.#fda #cgmp #gmp

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