21 cfr sop. "Pursuant to Section 11.

21 cfr sop. The template also includes an example of a typical approach for assessing a system for Part 11 compliance. Key provisions and compliance checklist. Standard Operating Procedures (SOP) The University of North ISO 13485 and 21 CFR 820, CFR 4 Standard Operating Procedure Templates – SOPs Our main expertise is the Quality Management field for drug products, drug substances (active pharmaceutical ingredients, API), medical devices and the ISO regulated industry. Bring your questions and prepare to interact with the instructor and your peers in the industry. Batch records, and training logs remain current, accessible, and version-controlled, aligning directly with FDA expectations for 21 CFR Part 211 compliance. Jun 29, 2025 · 21 CFR Part 211 compliance necessitates comprehensive, version-controlled standard operating procedures that are regularly reviewed. "Pursuant to Section 11. 21 CFR Part 11. The purposed of this procedure is to (define, describe, identify, provide, outline, establish) (guidance, guidelines, and Sep 20, 2017 · I think your initial premise is incorrect: "SOPs are reviewed and revised/updated at some frequency" (emphasis added). Jul 30, 2013 · PIs are required to follow the U. (a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. 2) Scope 58. Understand 21 CFR Part 11 requirements for electronic records and signatures, plus common mistakes and how to stay compliant in FDA-regulated industries. 6 Sanitation standard operating procedures. 3(y)] Product 21. Learn key requirements, validation tips, and best practices for regulatory success. Designed for human food processors, co-packers, and private labelers, these templates support key quality system functions Get easy-to-understand answers to some of the most common questions about 21 CFR Part 11 compliance for clinical trials. 1 PURPOSE This SOP and the attached “Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in Clinical Research at NIH,” (referred to hereinafter as “the Guide) (Appendix A) describe how financial and non-financial conflicts of interest in the conduct of clinical research, involving NIH researchers, will be disclosed, resolved or effectively managed. , unit, division, department, institution, etc. 2011 FDA defines 25 SOP provisions required by CFR Register now for ECA's GMP Newsletter The latest edition of the Federal Register* (Vol. In clinical research, SOPs help define the group’s (e. Also included on this page is information about proposed regulatory reforms, and UNC comments to these proposals. The Principal Investigator will not implement any changes to the protocol without sponsor approval and prior review and documented approval from the IRB, except when necessary to eliminate apparent immediate hazards to human subjects (21 CFR 312. 2. Feb 12, 2025 · Discover all you need to know about FDA 21-CFR Part 211 for pharmaceuticals to stay informed and ensure regulatory compliance in drug manufacturing. Feb 21, 2019 · Understanding 21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions This FAQ paper is a follow up to the webinar, “Understanding 21 CFR Part 11 and Data Integrity Regulations”. 1) This part describes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research Downloads GMP Regulation Handbook: Dietary Supplements, 21 CFR Part 111 (396. Many thoughtful questions were asked about the specific guidelines of 21 CFR Part 11 relating to data integrity, and how they impact operations. Browse cGMP SOP LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A—GENERAL PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Subpart E—Testing Facilities Operation § 58. This procedure establishes the process to create and update standard operating procedures and associated checklists and worksheets. (b) The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human use; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue-based products (HCT/Ps) and that are drugs 21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can use electronic records and digital signatures in their quality management systems to replace paper-based documents and ‘wet signatures’. Customize these standard operating procedure (SOP) templates to help comply with cGMP requirements. Jun 10, 2023 · A Final Word on 21 CFR Part 11 Compliance Compliance with 21 CFR Part 11 is an ongoing process, not a one-time event. 108, describe requirements for writ-ten procedures. 3: Definitions and Interpretations University of Utah Clinical Research UUSOP-06: Study Records Management. Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter F Part 606 —Current Good Manufacturing Practice for Blood and Blood Components Subpart F § 606. 21 CFR 820 definitely calls out for a review but no updates are mandated unless warranted. Procedures must be written clearly for operational staff to follow and should address all aspects of manufacturing covered by the regulation. 06 KB) 1 April 2017 GMP Regulation Handbook 21 CFR Part 111 Code of Federal Regulations US Food and Drug Administration Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 21 CFR - Part 111 Revisions as of April 2017 FDA-regulated studies conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application require that, in the absence of wet signatures, electronic signatures be obtained using a 21 CFR Part 11 (Part 11) compliant system; however, in the absence of a Part 11 compliant system and in the current circumstances Oct 15, 2025 · “headline”: “SOP for IDE-Specific Safety Reporting and Device Deviations (21 CFR 812)”, “description”: “This SOP defines procedures for IDE-specific safety reporting and device deviation management under 21 CFR 812. Template includes a 37 question checklist. Common SOP Topics: Jan 21, 2025 · Regulations help to ensure quality drug products. 103, companies that manufacture, package, label, or hold dietary supplements are required to “…establish and follow written procedures for the responsibilities of the quality control operations. 81 Standard operating procedures. Chapters II and III of Title 21 are related to oth Subchapter A: Part 11 falls under “Subchapter A – General” of Chapter I. Jul 25, 2025 · Master FDA 21 CFR Part 11 to avoid compliance pitfalls. 100 Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Introduction A small meat processor must understand the basic principles behind Sanitation Standard Operating Procedures (SSOPs) and Good Manufacturing Practices (GMPs) and how to comply with them. Official Sample (21 CFR 2. 35 (b-d)) - Review QAU SOPs to assure that they cover all methods and procedures for carrying out the required QAU functions, and confirm that they are being followed. Feb 4, 2025 · References 21 CFR Part 312: Investigational New Drug Application 21 CFR Part 312, Subpart D: Responsibilities of Sponsors and Investigators 21CFR Part 312. 3(b)(8) Jun 1, 2025 · A Comprehensive Guide to 21 CFR Parts 210 and 211 for GMP Compliance Compliance with the US FDA’s Good Manufacturing Practice (GMP) regulations is essential for any pharmaceutical manufacturer seeking to operate within or export to the United States. 100 of Title 21 of the Code of Federal Regulations, this is to certify that [name of organization] intends that all electronic signatures executed by our employees, agents Medidata offers a new standard when addressing these challenges: Introducing SOP Management — a 21 CFR, Part 11 compliant, validated, content integrity and collaboration platform for the modern digital workplace, and the first end-to-end collaboration platform that actively maintains inspection readiness. Ongoing education is vital to ensure that personnel remain updated on regulatory demands and best practices. This ensures that all processes involved in the design, production, and distribution of medical devices meet regulatory requirements for quality and safety. Title 21 was last amended 9/25/2025. Establish and maintain means For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). 188 / Wednesday, September 28, 2011) shows a very good summary of SOPs required by 21 CFR Part 211: "Written procedures (standard operating procedures - SOPs), are required for many Part 211 This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations The essential IT SOP's that you will need to have in place to meet the procedural control requirements of 21 CFR Part 11. Aug 22, 2014 · The SOP reflects the FDA’s approach for scope and application of 21 CFR Part 11 according to Reference 4. This guide offers tactics, insights, and a roadmap for robust electronic record and signature integrity. 263a) and Sep 13, 2021 · Identifying Electronic Records (21 CFR part 11) in the system’s URS and in the Global Procedures and SOPs that govern the business processes using Electronic Records. edu Feb 28, 2025 · 21 CFR Part 11 is a regulation established by the U. Food and Drug Administration (FDA): A three year old Notice focusing on specific recordkeeping requirements in the Federal Register also gives a very good summary of SOPs required by 21 Life sciences startup? Don't wait on quality. § 416. Currently the FDA is reexamining Part 11 and plans to initiate a new rule. Similarly, requirements for written SOPs are frequently mentioned in the The documents listed below are commonly needed regulatory or informational documents for the University of North Carolina at Chapel Hill Office of Human Research Ethics (OHRE) and the Institutional Review Boards (IRBs). Our Quality Management documents and standard operating procedure templates are built on the industry specific requirements and regulations Displaying title 21, up to date as of 9/29/2025. Aug 20, 2014 · The ECA Academy is receiving a lot of questions on SOPs (Standard Operating Procedures) needed in a GMP environment. S. 4 A valid electronic signature for consent and HIPAA authorization could be the subject's typed name or it could even be as simple as a check mark or an X or any other symbol in a box on a form. The process begins when the Office of IRB Administration (OIA) director, institutional official or designee determines that a standard operating procedure needs to be created or modified. If you're searching for a 21 CFR Part 11 compliance checklist, you're likely looking for a clear, practical guide to help ensure your systems, processes, and documentation align with FDA expectations. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. 3) Specification any requirement with which a product, process, service, or other activity must conform [21 CFR 820. § 58. C. Designs and maintains quality systems that ensure compliance to CGMP (21 CFR 211 and 21 CFR 600) and applicable GLP (21 CFR 58) regulations, guidance’s, and industry standards relating to the manufacture and testing of biologics and biopharmaceuticals for pre-clinical and Phase I & II clinical use. This dietary supplement GMP training course provides an overview of subparts A-P of the 21 CFR 111 regulation, including Guide to 21 CFR Part 11 Compliance: Electronic Records and Signatures in pharma, biotech, and medical devices. 116; FDA: 21 CFR 50. Where process controls are needed they shall include: (1) Documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production; (2) Monitoring and control of process parameters and component and device characteristics during production; (3) Compliance with specified reference standards or May 7, 2025 · Ensure FDA compliance with 21 CFR Part 11 for electronic records & signatures in pharmaceuticals, biotech, and medical devices. 40. 21 CFR Part 11 applies to Do you need Standard Operating Procedures? Our turnkey quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard and 21 CFR 820, 21 CFR 803, and 21 CFR 806 for the FDA. The ability of employees to electronically sign documents is vital to day-to-day operations. Creating and complying with SSOPs can be challenging for the small processor. 30 and 56. Here is an Overview: U. Food and Drug Administration (FDA) that outlines the detailed requirements for the manufacturing, processing, packing, and holding of finished drug products intended for human use. 11 General rules. 10; UNC CRSO: Guidance and Tips, Required Elements of Informed Consent) Provide prospective participants with information that a “reasonable person” would want to have to make an informed decision to participate Electronic signature and record-keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in Agency regulations, including parts Inactive ingredient (excipient) any component other than an active component, 21 CFR 210. 47- Donor Eligibility SOPs for all steps that you perform in testing, screening, determining donor eligibility and complying with all other requirements. 21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic Records (ER), and Part 11 of Title 21 of the Code of Federal Regulations (referred to as 21 CFR Part 11)1 was released August 20, 1997 and revised April 1, 2005. 100 - Standard operating procedures. 1 111. They are designed to ensure drug products’ identity, strength, quality, and purity. Given that, the “21 CFR Part 11” d, Drug, and Cosmetic Act from 1938. The Management Review is typically where I've seen the "periodic review" occurs (which lines up with 820. Oct 26, 2011 · 26. Title > Chapter > Subchapter > Part. Code of Federal Regulations 21 CFR 11: Electronic Records and Signature 21 CFR 1271. Establish and maintain procedures to control all documents required by 21 CFR Part 820 Procedures shall provide for: Document Approval Document Distribution Document Changes Document Approval Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A Part 58 —Good Laboratory Practice for Nonclinical Laboratory Studies Subpart E Electronic signature and record-keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in Agency regulations, including parts The purpose of this SOP is to define a structured approach for achieving and maintaining compliance with the FDA’s Quality System Regulation (QSR) outlined in 21 CFR Part 820. The most interesting is the one on which SOPs are required by law. This 21 CFR Part 11 Assessment template has been designed to verify and document a system’s compliance with FDA 21 CFR Part 11. 10) - An official sample is one taken from a lot for which Federal jurisdiction has been established. 150(a)(4)). ” One fundamental document that your organization should develop to fulfill this requirement is a Quality Unit Roles and Responsibilities standard For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Each official establishment shall develop, implement, and maintain written standard operating procedures for sanitation (Sanitation SOP's) in accordance with the requirements of this part. 21 CFR Part 11, regarding electronic records and electronic signatures outlines the criteria for Dietary Supplement GMP SOP Templates for 21 CFR 111 Compliance INTRODUCTION Our Dietary Supplement Good Manufacturing Practice (GMP) Standard Operating Procedure (SOP) Templates are meticulously crafted to ensure your compliance with 21 CFR 111 regulations. Jul 24, 2025 · 21 CFR Part 211, titled Current Good Manufacturing Practice for Finished Pharmaceuticals, is a core regulation enforced by the U. Jul 14, 2025 · Documentation control under QMS ensures that Standard Operating Procedures (SOPs). Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within a business organization. The SSOP shall address: 21 CFR 111 and SOP Requirements Under 21 CFR 111. This article breaks down the regulation into plain Purpose/Policy State the objective or reason for the procedure. LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F—BIOLOGICS PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Subpart F—Production and Process Controls § 606. FDA monitors drug manufacturers' compliance with Current Good Manufacturing Practice (CGMP) regulations. Part 11, ‘Electronic Records; Electronic Signatures’ states the rules, definitions and guidelines under which the FDA, Train personnel by providing thorough training for all employees on the new SOPs and emphasizing the significance of adhering to 21 CFR Part 211. The Principal Investigator (“PI”) retains CFR responsibility unless the investigator has specifically delegated this duty to another research team member and the delegation is documented on a study specific Delegation of Authority Log. Code of Federal Regulations TITLE 21--FOOD AND DRUGS PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Subpart A--General Provisions 111. It also includes procedures for Canadian Medical Device Licensing and European CE Marking. FDA inspections. e. We have a proprietary process by which we obtain immediate access to all world-wide FDA inspection information on a real-time basis. Procedural controls establish a framework for validating and maintaining the computer system and for ensuring that users understand how to use the system. We understand the critical importance of adhering to the Good Manufacturing Practices outlined in 21 CFR 111 when manufacturing dietary Definitions (21 CFR 820. With ever-evolving technological advancements, continuous education, training, and robust quality assurance systems are crucial for maintaining compliance. To establish FDA-compliant standard operating procedures (SOPs) for the acceptance, inspection, release, and distribution of imported food products in accordance with 21 CFR 117 Subparts B and E, this documentation set provides a comprehensive SOP package for importers, distributors, or warehouse operators seeking to verify product conformity prior to market entry. View the most recent version of this document on this website. Aug 4, 2025 · References 21 CFR Part 312 Subpart D: Responsibilities of Sponsors and Investigators 21 CFR Part 50: Protection of Human Subjects research 21CFR Part 56: Institutional Review Boards ICH Guidance for Industry E6 (R2): Good Clinical Practice FDA Guidance for Industry – Investigator Responsibilities (October 2009) Document Approval Erin Rothwell SOPs are Required by Law Many parts of Title 21 in the Code of Federal Regulations (CFR), such as 21 CFR Parts 11. ) standard practices and daily processes conducted to assure execution of research tasks in When you automate collection, processing, and analysis of research information, you are creating an electronic record. (a) In all instances, except clinical investigations, standard operating procedures shall comply with published additional standards in part 640 of this chapter for the products being processed; except that, references in part 640 relating to licenses, licensed establishments and submission of material or data to or approval by the Director § 120. (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. If violative, the official sample provides a basis for an Oct 24, 2024 · Learn everything you need to know about 21 CFR Part 11 compliance, including electronic signatures, electronic records, and implementation requirements for FDA-regulated industries. For 21 CFR Part 11 compliance, organizations can use SOP templates tailored to electronic record management, electronic signatures, and audit trail reviews. AHPA cGMP SOP Templates The dietary supplement current good manufacturing practice (cGMP) rule (21 CFR part 111) requires supplement manufacturers to establish and follow federally mandated current good manufacturing practice to ensure the quality of the dietary supplement. The purpose of 21 CFR Part 11 is to enable industries to transition from paper-based systems to electronic data management while maintaining compliance with FDA regulations. It implements 21 CFR Part 7 Subpart C – Recalls (Including Product Corrections) – Guidelines on Policy, Procedures, and Industry Responsibilities. 65(f) provides an exemption for transfusion services which are a part of a facility that is certified under the Clinical Laboratory Improvement Amendments of 1988 (42 U. Can someone help please? Policies, Procedures & Guidance Standard Operating Procedures (SOPs) for Clinical Research Standard Operating Procedures (SOPs) for Clinical Research are established to ensure we articulated our expectation for clinical research execution standards that adhere to federal and state regulations and institutional policies. QAU Operations - (21 CFR 58. 3(y)] Product Jul 23, 2021 · any future questions or concerns (Common Rule, 2018 Requirements: 45 CFR 46. Each question is cross-referenced to a requirement within 21 CFR Part 11. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing. Learn why a proactive, compliant QMS from day one is essential for faster market entry, investor confidence, and avoiding costly regulatory pitfalls. The 21 CFR 111 GMP training is interactive, with hands-on exercises including case studies from recent warning letters. 21 CFR Part 11 exists to give the agency assurance that electronic records are the same as paper records. May 21, 2025 · The Ultimate Comparison: ISO 13485 vs. Clinical Research Support Office, IND Specialist webpage: https://ctsi. 25; ICH E6 Guideline for GCP, 4. 5 Who is subject to this part? What definitions apply to this part? Do other statutory provisions and regulations apply? To establish foundational compliance with FDA’s current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for human food, this documentation package provides fully editable SOP templates aligned with 21 CFR Part 117. May 8, 2025 · Meeting 21 CFR Part 11 requirements is a critical concern for teams managing electronic records and signatures in FDA-regulated environments. utah. g. PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Standard Operating Procedures (SOPs) Standard Operating Procedures (SOPs) are essential for ensuring consistent and compliant processes within an organization. At the heart of these regulations are 21 CFR Parts 210 and 211, which outline the minimum requirements for the manufacturing, processing The Ultimate Resource for Pharmaceutical SOPs and Best Practices. 14) in SPL format, and may include electronic rendering/images (. 66 and/or 21 CFR 812. 20 (c)). Feb 7, 2012 · I need some guidance on how often company SOPs need to be reviewed per FDA regulations. 10. , SOPs, with documentation to support conformity with the same. For meat and poultry processors, SSOPs are the foundation of the plant’s many food safety programs. Approval of access requests and periodic review of users’ accounts and privileges. Procedural controls usually take the form of standard operating procedures (SOPs) and user manuals. 76, No. Food and Drug Administration (FDA) to ensure the integrity, reliability, and authenticity of electronic records and electronic signatures. 3. FDA 21 CFR OpenRegulatory Guidance on FDA Title 21 CFR Part 11 regulations for electronic documentation and electronic signatures and how it impacts Clinical Trials. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. 4 days ago · GMP Trends® was created to provide relevant, real-time, unbiased information derived from actual U. 100 Standard operating procedures. May 23, 2025 · Tractian’s 21 CFR guide breaks down how to keep your maintenance audit-ready with 10 proven tips, from SOP control to CMMS-driven execution. 3 111. Final content of labeling (21 CFR 601. Jul 19, 2022 · Scope of GLP Regulations (21 CFR 58. Is it annually? There is no reference under 820. 1 21 CFR 607. The regulations describe that a facility must have written procedures, i. Definitions (21 CFR 820. 10, 11. (a) Sanitation controls. And understanding RESPONSIBILITY: This SOP sets forth responsibilities of research team members involved with completing and correcting CRFs and resolving CRF queries/edits. jpeg) of cartons and containers. Apr 1, 2003 · 21 CFR 606. What is 21 CFR Part 11? 21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Sep 4, 2023 · The FDA 21 CFR Part 211 defines SOPs as written procedures describing how to perform specific tasks or operations in producing pharmaceutical products. Establishing a procedure for linking handwritten signatures to their electronic records. 8. sqqp0 od cbb1f lefx35p jqvjnqtq hbtqu rj5 qzov metu smb2j9