Regulatory Issues in Laboratory Management 1/18/2007 Subpart E: Testing Facilities Section 58.81 Standard Operating Procedures [SOPs] Marilyn Marshall

Standard Operating Procedures [SOPs] Subpart E: Testing Facilities Section 58.81 Standard Operating Procedures [SOPs] (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 study. All deviations in a study from the SOPs shall be authorized by the study director and shall be documented in the raw data. Significant changes in established SOPs shall be properly authorized in writing by the management.

Subpart E: Testing Facilities 58.81 SOPs…. (c) Each laboratory area shall have immediately available laboratory manuals and SOPs relative to the laboratory procedures being performed. Published literature may be used as a supplement to SOPs. (d) A historical file of SOPs and all revisions thereof, including the dates of such revisions, shall be maintained.

SOPs Standard Operating Procedures….. Backbone of the laboratory Gives specific instructions of how to do a method Uniform….everyone does it the same way Lab manager and Study Director sign and date indicating approval

Standard Operating Procedures Purpose Consistency between lab personnel Consistent procedures Can be referenced in protocol Reconstruct facility practices at time of study conduct

Standard Operating Procedures Should be…. Written by individuals completely familiar with the process; based on experience and scientific expertise Reviewed by newest trained person for clarity and thoroughness Function as an adjunct to training in a procedure or function

Standard Operating Procedures Benefits Serves as guidelines in training new staff Reduce time spent documenting routine procedures Checklists are in the SOP Minimize errors/repeats Allows management to assure correct scientific practices

Standard Operating Procedures Terms & Phrases to Avoid Timely As needed As soon as practical Immediately Appropriate Adequate Approximately

Standard Operating Procedures Terms & Phrases to Avoid (cont) Frequently…. if used give minimum acceptable time frames Reference operators manuals only for troubleshooting and operation Limit subjectivity and therefore conflicts of opinion Keep in mind, revisions will be a never ending process

SOPs Should cover all aspects of Laboratory Management Administrative Policies General Laboratory Procedures Ordering Time Sheets Bench top cleaning Lab clothing requirements Chemical Record/Inventory SOP format Laboratory definitions

SOPs Administration Personnel Training Records Training of new lab personnel Evaluation of personnel Responsibility of updating training records

SOPs Administrative Safety Biosafety Issues Chemical Safety issues Reporting of Lab Accidents Safety Plan

SOPs Administrative Data handling, storage and retrieval Handling of raw data sheets Handling of QC checklists Handling of forms Lab note books

SOPs Technical Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles logs Test system observations Checklists Laboratory tests Reporting raw data/logs/forms Collection and identification of specimens Chain of Custody forms

SOPs Technical Maintenance of equipment Maintenance time schedule for: Centrifuges Biosafety hoods Microscopes Incubators Archiving of maintenance records

SOPs Technical Calibration of equipment Calibration schedule for: Pipettors Scales instruments

SOPs Technical Preparation of solutions Cell culture media preparation Enumeration of cells or organisms Data sheets for all calculations Use of centrifuge or pH meter Staining of slide

SOPs You need a SOP to established a format of how to prepare a SOP….so AA 01 should be Preparation of SOP

Sample format for SOPS Preparation of SOP

Format of SOP Identification and control Each classification shall be assigned a unique identification code using 2 letters and 2 numbers AA 01 Administration RG 01 Reagents MT 01 Molecular Techniques TC 01 Tissue Culture

Identification and control Heading of each page Format of SOP Identification and control Heading of each page Unique ID number and revision # Effective date of the SOP Pagination [page x of x] AA01 Rev.# 00 Date: 01/18/04 Page 1 of x

Format of SOP 1.0 Purpose is …. describes ….. 2.0 Applicability …applies to …state who performs the procedure associated with the SOP 3.0 Safety and handling …. Describes any chemical or infectious materials [gloves need to be worn]

4.0 Equipment and Materials…. list equipment [Ph meter] Format of SOP 4.0 Equipment and Materials…. list equipment [Ph meter] list chemicals/reagents list glassware checklists or log books

Format of SOP 5.0 Procedure Identify the step by step sequence of activities to be followed for this procedure Include specific instructions for each reagent used Include clear explanation as to how the final result is determined and the units of the result to be reported Include instruction to validate results

6.0 Supplemental Documents Format of SOP 6.0 Supplemental Documents Include all forms and documents which are applicable to the procedure and where these forms will be archived List forms/checklists 7.0 References List appropriate references for procedure

8.0 Substantive Revisions Format 8.0 Substantive Revisions For all revisions to an original SOP, this section will describe what changes have been made in each section of the document SOP will be reissued after review and approval by Study Director and Lab manager…signed and dated

Format 9.0 Signature and indication of record control A signature and date is required by the laboratory manager and study director after review and approval of SOP The date on the heading of the page will be changed to reflect the date of approval by placing a line through the typed date and correcting in ink the date of approval. Initials will be placed by the ink date.

Sample format for SOPS Freezers and Refrigerators

Class Assignment: SOPs due January 30 2007