Documentation and Good Documentation Practices

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).

 

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