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Pharmaceutical Documentation

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Pharmaceutical Documentation

  1. 1. Pharmaceutical Documentation Presented By Dr.Safder Ali Bhatti AssistantManager Production
  2. 2. Content of Presentation  Introduction  Good Documentation needs  Why essential?  Types of documentation  Constitutes of Good documentation  Changes or Amendments in Documentation  Common Documentation Errors  Principles of Good Documentation Practice  Benefits of Good Documentation Practice
  3. 3. Introduction  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.
  4. 4. Introduction  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
  5. 5.  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
  6. 6. 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”
  7. 7. 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.
  8. 8. 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, potentially reducing patient safety.  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.
  9. 9.  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?
  10. 10. Types of Documentation  Documentation may be divided into; 1. Documents-procedural or instructional documentation  Benefits: o Reference for future use or a means to communicate information to others. o Particularly important to ensure that knowledge is not lost when employee leaves. o Ensure the Quality & Consistency of processed/activities/manufacturing
  11. 11. Types of Document Used Types of document used: MPs Training schedules change Control documents Calibration form Temperature & humidity Chart CAPA Daily Plans DPRs Emergency repair & maintenance form SOPs
  12. 12. Types of Documentation 2. Records-evidence of Compliance  Benefits: o Provide background history o Protects intellectual property(Evidence of an idea or a finding including the date and the responsible person) o Provide legally valid evidence
  13. 13. Types of Records used Types of Records used: ERP(OPM) Humidity and temperature control records Cal iberation records Emergency & maintenance records Training records BMRs Log Books
  14. 14. 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
  15. 15. 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.
  16. 16. Changes or Amendments are made in a Compliant manner A. Making a Legible Correction: If correction needs to be made, the original record must still be legible: 1. Make a single line through the error-never use correction fluid, multiple cross- marker pen to obscure the original record. 2. Provide a brief comment why the change is required(as appropriate) 3. Initial the change so that it is clear that the correction is deliberate. 4. Record the date of the correction next to the initials so that there is a record of when the change was made.
  17. 17. Making a Legible Correction:
  18. 18. Changes or Amendments are made in a Compliant manner B. Handling Omitted data: If an entry was omitted and must be made at a time later than the activity was performed then: 1. Clearly indicate the date the activity was performed and the date the activity is recorded on the documentation. 2. Document an explanation to substantiate the entry & reason for the delay in recording. 3. Sign & date the change.  Important: Back dating of entries is not permitted
  19. 19. Handling Omitted data:
  20. 20. 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
  21. 21. 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 e.g ditto marks or arrows to indicate repetitive and consecutive
  22. 22. 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.
  23. 23. 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

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