DOCUMENTATION: THE FOUNDATION OF QUALITY

Lab Workers Prepare Their Documentation

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”.

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

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

Audit FDA inspector comes to the facility!!!

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

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

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

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

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.

4. The technician will record information about the solution. a)Preparer’s name b)Date c)Steps

a)Quantities and sources of raw materials b)Storage location and conditions c)Amounts of components d)ID number of solution

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

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

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

A Lab Notebook Is Not A Report A laboratory notebook is not the same as a report.  Lab notebook is chronological 1.May not be entirely “neat” 2.May have procedures materials mixed with results

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

Annotated Lab Notebook Page

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

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.

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

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

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?

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

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