Research Support & Regulatory Affairs Quality Assurance Unit

1. WRITING STANDARD OPERATING PROCEDURES (SOPs) Raymond C. Anderson, PhD When: Wednesday, August 23, 2006 9:00 – 11:00 am Where: Biomed I – Room 205/207 Research Support & Regulatory Affairs Quality Assurance Unit

2. WHAT IS AN SOP?

3. WHY WRITE SOPs?

5. GOALS • Define what is an SOP • State reasons for writing SOPs • Describe the different formats for SOPs • Describe how to write an SOP

6. WHAT IS AN SOP?

7. WHAT IS AN SOP? Standard operating procedures are a set of instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. en.wikipedia.org/wiki/Standard_Operating_Procedures

8. WHAT IS AN SOP? An SOP is a set of instructions or steps someone follows to complete a job safely, with no adverse impact on the environment (and which meets regulatory compliance standards), and in a way that maximizes operational and production requirements. Kenneth A. Friedman, PhD Department of Journalism and Communication Lehigh University, Bethlehem, PA

9. WHAT IS AN SOP? An SOP is a set of written instructions that document a routine or repetitive activity. EPA Quality System Frequent Questions – Standard Operating Procedures (SOPs) www.epa.gov/quality/faq7.html

10. WHAT IS AN SOP? SOPs: Detailed written instructions to achieve uniformity of the performance of a specific function. ICH E6 Good Clinical Practice: Consolidated Guidance

11. WHY WRITE SOPs? To provide people with all the information necessary to perform a job properly (i.e. a training tool) To ensure that the procedures are performed correctly and consistently To ensure compliance with university and government regulations

12. WHY WRITE SOPs? To serve as a checklist for auditors To serve as an explanation of steps in a process so they can be reviewed in accident investigations. To serve as a historical record of the how, why and when of steps in an existing process occurred (for inspectors and attorneys)

13. WHY WRITE SOPs? To Ensure Safety Maximize operational and production requirements

14. WHY WRITE SOPs? To Ensure Consistent Training To Ensure Correct and Consistent Performance To Ensure Regulatory Compliance

15. WHY WRITE SOPs? To Ensure Consistent Training To Ensure Correct and Consistent Performance To Ensure Regulatory Compliance Just Because It Makes Good Sense

16. WHY WRITE SOPs? Because historically many have not exercised good sense and failed to provide adequate training and consistency in performance, product or process failures have resulted in harm to animals, research subjects and patients.

17. WHY WRITE SOPs? The FDA Has Placed Us In An Environment of Regulatory Compliance!!!!

18. WHY WRITE SOPs? Most regulatory and accrediting agencies require that those who perform procedures have the education, experience and training to do so.

19. WHY WRITE SOPs? SOPs are the foundation of training!

20. REGULATORY REQUIREMENTS Good Manufacturing Practice 21 CFR 211.100 There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

21. REGULATORY REQUIREMENTS Good Laboratory Practice 21 CFR 58.81(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.

22. REGULATORY REQUIREMENTS Good Tissue Practice 21 CFR 1271.180 You must establish and maintain procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps. You must design these procedures to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases through the use of HCT/Ps.

23. REGULATORY REQUIREMENTS ICH Guidance For Industry E6 Good Clinical Practice: Consolidated Guidance Principles of ICH GCP § 2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.

24. FOCUS OF FDA INSPECTIONS BIORESEARCH MONITORING BIMO Compliance Program Guidance Manual Chapter 45 – Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848

25. Six Key Systems: Quality System Process Facilities and Equipment Materials Packaging and Labeling Laboratory Control Three Critical Elements: SOPs Training Records FOCUS OF FDA INSPECTIONS

26. Common Elements GLP & GMP & GTP QA Unit Processing SOPs Records Personnel Facilities Equipment Reagents

27. REGULATORY REQUIREMENTS Strive to create a culture of compliance

28. FORMATS FORSOPs There are almost as many different formats as there are institutions, agencies and companies that write them. Pick One Document It Enforce It You Need and SOP on SOPs

29. AN IMPORTANT POINT An SOP is not a Policy A policy tells you WHAT you will do, An SOP tells you HOW you will do it!

30. A Policy UAMS ADMINISTRATIVE GUIDE NUMBER: 3.1.15DATE: 03/05/2002REVISION: 08/15/2005 SECTION:ADMINISTRATION AREA:GENERAL ADMINISTRATION SUBJECT: CONFIDENTIALITY POLICY

31. A Policy UAMS prohibits the unlawful or unauthorized access, use or disclosure of confidential and proprietary information obtained during the course of employment or other relationship with UAMS.   As a condition of employment, continued employment or relationship with UAMS, UAMS workforce shall be required to sign the UAMS Confidentiality Agreement approved by the UAMS Office of General Counsel.  

32. A Policy UAMS will provide training for each of its workforce members on the importance of maintaining confidentiality and the specific requirements of state and federal law, including the HIPAA Privacy Regulations and laws protecting the privacy of students and employees. This policy applies to information maintained or transmitted in any form, including verbally, in writing, or in any electronic form.

33. UAMS Administrative Guide This Administrative Guide contains sections for Both Policy and Procedure. It also includes Scope, Purpose and Forms associated with the procedure.

34. SOP FORMATS THREE MAJOR TYPES Standard List Outlined List Playscript

35. WRITING “GOOD” SOPs Accurate Up to Date Easy To Understand and Follow Accomplishes the purpose for which it is written

36. SUGGESTED FORMAT PURPOSE SCOPE RESPONSIBILITY REFERENCES DEFINITIONS PROCEDURE ATTACHMENTS REVISION HISTORY

41. WHERE TO START Why Is An SOP Needed? Who Is The Target Audience? Will The SOP Be Inter-Departmental? Who Will Write The SOP?

42. WHERE TO START Just Get Something On Paper (Writers Block) Use A Flow Chart

43. TITLE This must describe in sufficient detail the focus of the SOP so that anyone can tell from the title the content of the SOP when searching a list of SOPs This More Important Than You Think!

44. PURPOSE What You Want To Accomplish This often will duplicate the title of the SOP: Title: Writing, Review and Approval of Standard Operating Procedures The Purpose of this procedure is to define the process used to write, review and approve standard operating procedures of the Quality Assurance Unit or To define the process used to write, review and approve standard operating procedures of the Quality Assurance Unit

45. SCOPE The scope defines the area to which the SOP applies: This procedure applies to all policies and procedures used by the Quality Assurance Unit

46. RESPONSIBILITY This states who has responsibility for training and execution of the SOP: It is the responsibility of the Quality Assurance Manager or designee to assure that all Quality Assurance Specialists are trained on and comply with this standard operating procedure

47. RESPONSIBILITY You may want to include other statements in the responsibility section as suggested by your accrediting body. You must state this in your SOP on SOPs

48. REFERENCES List all references that serve as the basis for the SOP Do not list regulations, text books, standards, or articles, etc. without reference to sections or page numbers!

49. REFERENCES 4.0 REFERENCES 4.1 ORC SOP 100.01 Policy and Standard Operating Procedure, Creation, Revision, and Implementation Standards 4.2 21 CFR 58.35(c) 4.3 21 CFR 211.22(d) 4.4 21 CFR 820.20(a) 4.5 21 CFR 820.20(e) 4.6 21 CFR 1271.160(b)(1) NOT 21 CFR 211

50. DEFINITIONS List all definitions that are essential to an understanding of the SOP including all acronyms