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Documentation Management and Control

What is Documentation ?

 “Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use.”

Documentation provides Both;

  1. Information on when, where, who, why & How to Complete tasks
  2. Evidence providing that the tasks have been completed as they should be.

Good Documentation Practice (GDP) “GDP describes the standards by which documentation is Created and Maintained in the pharmaceutical industry”

The basics of GDP

  • To meet industry Standards, it is critical that all documentation follow GDP when it effects
  • GMP processes
  • Materials or product identity, quality, strength & safety
  • The validated state of GMP product manufacture, facilities, equipment, computer

Document “is information (meaningful data) and its supporting medium, in form of paper, CD, Computer file, microfilm, x-Ray film etc” Documents provides information or evidence or may serve as an official record.

Record “is a document stating results achieved or provide evidence of activities performed” Introduction

Guidelines “is a document that provides recommended practices and instructions”

Policy “is a plan or adopted course or principle of action intended to influence and determine the decisions or actions of an organization”

Good Documentation needs?

  • Approve, review & update documents
  • Change & current revision status of document identified
  • Relevant versions of applicable documents available at point of use
  • Document remain legible and readily identifiable
  • Documents of external origin identified, and their distribution controlled
  • Prevent unintended use of obsolete documents, and archiving.

 Why Good Documentation is essential?

  • In a GMP Environment, Documentation needs to meet certain requirements to ensure Product Quality & Product Safety.
  • If an instruction or record is poorly documented, then the manufacturer or Quality assurance/control of a product can be negatively impacted.
  • Consequently, the standards of documentation within a company can directly impact the level of success in manufacturing quality products that are safe as well as success during audit situations.
  • Ensures documented evidence, traceability, provide records and audit trails for investigation
  • Ensures availability of data for validation, review and statistical analysis. — Control of Process - Ensures all staff knows what to do and when to do it.
  • To improve performance
  • Regulatory requirements. Why Good Documentation is essential?

Types of Documentation

Documentation may be divided into;

  1. Documents-procedural or instructional documentation

Benefits:

  • Reference for future use or a means to communicate information to others.
  • Particularly important to ensure that knowledge is not lost when employee leaves.
  • Ensure the Quality & Consistency of processed/activities/manufacturing
  1. Records-evidence of Compliance

Benefits:

  • Provide background history
  • Protects intellectual property (Evidence of an idea or a finding including the date and the responsible person)
  • Provide legally valid evidence

Types of Records used Types of Records used: ERP(OPM) Humidity and temperature control records Calibration records Emergency & maintenance records Training records BMRs Log Books

What constitutes Good Documentation

  • Clearly Written documentation: All documents must be accurate & written in a manner that prevents errors and ensure consistency.
  • Using indelible ink: All records must be filled out in indelible ink for long term legibility. Don’t use pencil or ink that can be erased
  • Legible hand-written entries
  • Reviewing & approving
  • Staff Signatures: Hand written Signature must be unique to the individual and listed within the site signature register to ensure that signature is traceable to a member of staff. Staff are not permitted to sign for another member of staff unless delegated.
  • Page Numbering

What constitutes Good Documentation

  • Concise: The document must provide clear information that is understood by all customers
  • Traceable: Who recorded it, where and why
  • Contemporaneous: The information should be documented at the correct time frame along with flow of events
  • Enduring: Long lasting and durable
  • Accessible: Easily available for review.

Common Documentation Errors

  • Missing signature and dates at the time of activity performed.
  • The write-over
  • Non-uniform date and signature entry
  • Writing a note that activity was performed on one day and signed for on other day.
  • Blank spaces
  • Illegible writing
  • Too many corrections

Principles of Good Documentation Practice

  • A document bearing original signatures should never be destroyed.
  • Never falsify information
  • Never you a White-out and cover-over-tapes
  • Never obliterate information or record
  • Never over-write a record.
  • Never use pencil – all information should be completed in permanent Black or Blue ink
  • No spaces, lines or fields are to be left blank
  • Never use symbols like ditto marks or arrows to indicate repetitive and consecutive

Benefits of Good Documentation Practice

  • Build confidence in the Quality of product
  • Reduce efforts to compliance with regulatory bodies
  • Allows for achievements of required results.
  • Correct, complete, current and consistent information effectively meets customers and stakeholders’ requirements.
  • Enables the Production activities to be arranged into functional patterns for specific action.
  • Create structures so that staff can systematically coordinate to conduct business.

Benefits of Good Documentation Practice

  • Training of production staff.
  • Solve complicated problems
  • Reduce or eliminate assumptions and second- guessing
  • Eliminate the need to re-ask the same questions
  • Specify clear instructions for staff