Documentation and Good Documentation Practices

Common Documents

There are over two dozen different types of documents used when working in a controlled environment. Although the contents vary from document to document, the majority of documents contain some similar information. One example is a header (see sample image below).

Doc Header.png

 

Document Types

Records

  • Batch Records (BR’s) and Test Records (TR’s)
    • Directs operators on how to make or test the product
    • Accompanies product/test as it is made/performed. Must be followed exactly
    • Contains blank spaces that are filled in as each task is performed, then signed by operator
    • Critical steps are witnessed & signed
    • A controlled copy is issued by QA each time a new batch of the product is made
    • Data is recorded on them in “real time”
  • What is in a Batch or Test Record? Components of Batch/Test Records:
    • Header
    • Procedure
      • Details what operator will do in chronological order
      • Includes monitoring specifications so operator will know if process is proceeding properly
      • Blanks to collect raw data
      • Materials and equipment listed & Lot #’s/ID’s recorded
      • Signatures to identify operators
    • Label Information
      • Specific instructions for labeling in-process samples and final product
    • Storage
      • Total number of containers
      • Conditions

Logs

  • Equipment Cleaning and Use Log
    • Written record of major equipment cleaning, maintenance & use
  • Must show: date, time, product, lot number of each batch
  • Persons doing the cleaning or maintenance date & sign (or initial)

Standard Operating Procedures

  • Primary documents of Process Control
  • Typically followed for:
    • Equipment use, cleaning & maintenance
    • Department responsibilities
  • The first SOP written should be a procedure for writing SOP’s, which should include
    • Format & contents of procedures to be written
    • Responsibility for writing, numbering, approving, distributing, controlling, revising, and archiving SOP’s
  • What’s in a SOP?
    • Header
    • Purpose and Scope: What it is about and who it applies to
    • Definitions/Principle: Definitions of technical terms- Why it is done, why it is important, and how it works
    • Responsibilities: Technician (following procedure), Supervisor (training, reviewing, compliance), Manager (reviewing & compliance), QA (Audits & Archives)
    • Material/Equipment/Reagents: Identity of material, Concentration, pH, Sterile?
    • References: Other SOPs, Forms, Literature, Manuals (Equipment)
    • Procedure
      • Step by step, reasonably detailed
      • Use specific numbers only if required; otherwise use ranges
      • Write in active voice
      • “Wash the tray” instead of the “tray is washed”
      • Include what to record and where to record it
      • Include what to do if something doesn’t work
      • If a form is to be submitted, say to whom or to where

In the FDA’s view, it is much worse to not follow a written procedure, than to improvise on a procedure that could be improved

Reports

  • Receiving Report
    • Documents raw materials entering facility
    • Raw materials are assigned a receiving number, which is recorded on the report
    • Receiving report and Certificate of Analysis (COA) given to QA
      • QA notifies QC to sample material and begin testing if necessary
    • Deviation Report
    • Investigation

Specifications

  • Types of specification sheets: facility, equipment, raw materials, reagents, process intermediates, products
  • Raw Materials Specification Sheet
    • Describes the specifications raw material must meet to be suitable for use in production, e.g., pH 7.00-7.50
    • Tested by QC to confirm meets spec.
  • Final Product Specification Sheet
    • Describes the attributes the final product must meet to be released by QA, e.g., purity > 90%
    • Tested by QC to confirm

 

Document Control

  • Completed by Quality Assurance (QA)
  • QA establishes organized systems for: master documents, document numbering, document storage, document distribution, revision/ “change” control, archival
  • Note: A controlled document is any document in the Quality Management System

Document Numbering System

  • Used to control documents
  • Should be logical, traceable, unique
  • Controlled SOP written to describe the numbering system & personnel responsible for administering it