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

2. 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.

3. 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.

4. 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

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

6. 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

7. 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

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

9. 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

10. 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

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

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

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

14. 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

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

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

17. 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

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

19. Sample format for SOPS
Preparation of SOP

20. 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

21. 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

22. 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]

23. 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

24. 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

25. 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

26. 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

27. 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.

28. Sample format for SOPS
Freezers and Refrigerators

33. Class Assignment:
SOPs due January