1. DOCUMENTATION: THE FOUNDATION OF QUALITY

2. Lab Workers Prepare Their Documentation

3. Documentation Is Important!
“Do what you say; say what you do”.
“If it isn’t documented, it wasn’t done”.
“Companies make two products, the one that is sold and the documents that go with it”.

4. Function of Documentation
Ensure traceability
History and location of a product
The components of a product
Helps ensure that if problems arise, origin of the problem can be traced to components

5. Traceability Continued
Product can be found and recalled if necessary
Legal and accountability issues arise often many years after product was made
Traceability depends on an organized, well-designed system of documentation

6. Audit
FDA inspector comes to the facility!!!

7. First thing they check is that all documentation is present
That documentation is internally consistent
Documentation reflects what people really do
Auditors look closely at documentation

8. Types Of Documents: Laboratory notebooks.
Standard Operating Procedures (SOPs)
Batch records
Equipment/Instrument logbooks
Electronic documents
Training logs

9. More Documents Numbering systems Labels Chain of custody forms
Regulatory submissions
Release of final product record

10. Example Technician in a company prepares a 1 M solution of NaCl:
The technician will follow an approved standard operating procedure.

11. 2. The raw materials -- clean glassware, NaCl, and purified water -- will all have documents associated with them that show they were tested and satisfactory.
3. The instruments used to weigh NaCl and measure water have logbooks showing they were properly maintained.

12. 4. The technician will record information about the solution.
Preparer’s name
Date
Steps

13. Quantities and sources of raw materials
Storage location and conditions
Amounts of components
ID number of solution

14. 5. Solution will have an identifying number and documentation associated with assigning the number.
6. Solution will have a distinguishing label.
Label

15. Laboratory Notebooks Assigned to individuals.
Chronological log of everything that individual does and observes.
Primary form of documentation in a research laboratory.

16. Legal document
Used to establish a patent claim
Assign credit for a discovery
Document the honesty and integrity of data
Trouble-shooting
Can be subpoenaed
Can be examined by regulatory agency

17. A Lab Notebook Is Not A Report
A laboratory notebook is not the same as a report.
Lab notebook is chronological
May not be entirely “neat”
May have procedures materials mixed with results

18. Mistakes
Sometimes people record information on separate sheets of paper
Forgot lab notebook
Want to keep the lab notebook neat and orderly
DON’T!!

19. Annotated
Lab Notebook
Page

20. SOPs Are Very Important
Phrase often repeated in GMP: “there shall be procedures for…”
This means that by law, companies that are compliant with GMP must have SOPs
SOPs are documents that spell out how to do something, procedures

21. Production facilities and many laboratories use documents SOPS
Instruct personnel in how to perform particular tasks.
Step-by step outline of how a task is to be performed.
Indicate in which situations the task is done
Who is qualified or responsible for the work
Etc.

22. Since everyone follows the same SOPs, they help ensure that work is performed correctly and consistently over time.

23. Some Types Of SOPs Administrative SOPs
Such as how to assign lab notebooks
Processes
Such as how to investigate problem
Tasks
Such as how to operate a balance

24. Writing SOPs
What is the purpose of the procedure? What will be the outcome or product of the procedure?
What resources and materials will the person performing the SOP require in order to achieve the desired result?

25. Batch Records Document that accompanies product as it is made
Directs operators in how to make product
Provides blanks that are filled in as product is made
For critical steps, witness watches and signs

26. Moral Of The Story Keep good records, wherever you work
Don’t obscure problems or mistakes
Dating is critical, keep records chronological, that is, in order by date