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Good Documentation Practice
Good Documentation Practice is important to ensure activities are properly documented. GDP defines documents as instructions that guide how activities are executed, while records provide evidence activities were performed. Documentation must be accurate, concise, legible, traceable, contemporaneous, enduring and accessible. It is important to never falsify, obliterate or improperly correct information in records. All activities should be fully documented at the time they are performed. Reviews are necessary to check for completeness and compliance. Maintaining proper documentation is important for regulatory compliance, building confidence, meeting requirements, and solving problems.
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Good Documentation Practice
- 1. Good Documentation Practice Dr.A. Amsavel
- 2. Index Introduction Definition Documents required Records tobe maintained Good Documentation practice
- 3. Why GDP isimportant Proverb: “IF YOU HAVE NOT DOCUMENTEDAN ACTIVITY, YOU HAVE NOT DONE IT”. Document all the activities performed Do not perform the activity if it is not documented.
- 4. Definition Documents: An approved instructioneither in paper or electronic form which guides about how an activity shall be executed. Records: • Records provide evidence that activities have been performed or results have been achieved. A record is often considered as document. They always document the past.
- 5. Documentation must be; Accurate: true / precise, error free, Concise: short & clear information that is understood by all Legible: shall be readable , undertanadable. Traceable: who recorded it, where, when and how Contemporaneous: documented at the time activity done Enduring: Long lasting and durable Accessible: Easily available / retrievable What is Good Documentation Practice Shall be Complete & Authentic:
- 6. Principles of GDP Adocument with original signatures should never be destroyed. Never falsify information Never do white-out and cover-over-tapes Never obliterate information or record Never over-write a record. Never use pencil – use permanent ink for writting No spaces, lines or fields are to be left blank Never use symbols e.g ditto marks or arrows to indicate repetitive and consecutive entry
- 7. Observations on PoorDocumentation Practices Missing signature and dates at the time of activity performed. Non-uniform date and signature Activity was performed & writing on one day and signed on another day. Blank spaces Illegible writing Too many corrections Write-overs, multiple line-through "White-out" or other masking device Error correction not signed/dated, and reason for the correction not written Not traceable Data integrity
- 8. Benefits of GDP Complianceto regulatory requirement- No observation / warning letters/Import Alert/ ban Build confidence on System & practice Correct, complete, current and consistent information Effectively meets customers and stakeholders’ requirements. Ensure the traceability Useful for review , investigation & CAPA Solve complicated problems Reduce or eliminate assumptions and second-guessing. Eliminate the need to re-ask the same questions Specify clear instructions to staff Consistent quality, yield and performance of staff.
- 9. Q7: DOCUMENTATION ANDRECORDS (6) A. Documentation System and Specifications (6.1) 1. All documents should be prepared, reviewed, approved, and distributed. 2. The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining revision histories. 3. A procedure should be established for retaining until specified retention periods 4. When entries are made in records, these should be made indelibly in spaces provided for such entries, directly after performing the activities, and should identify the person making the entry. 5. Corrections to entries should be dated and signed and leave the original entry still legible. 6. During the retention period, originals or copies of records should be readily available
- 10. Q7: DOCUMENTATION ANDRECORDS (6) B. Equipment Cleaning and Use Record (6.2) 1. Records of major equipment use, cleaning, sanitation, and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment and the person who performed the cleaning and maintenance. 2. If equipment is dedicated to manufacturing one intermediate or API, individual equipment records are not necessary 3. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use can be part of the batch record or maintained separately.
- 11. Q7: DOCUMENTATION ANDRECORDS (6) C. Records of Raw Materials, Intermediates, API Labeling and Packaging Materials (6.3) Records should be maintained including: • The name of the manufacturer, identity, and quantity of each shipment of each batch of raw materials, intermediates, or labeling and packaging materials for API's; and date of receipt. • Inspection & test, status of incoming materials; • Records tracing the use of materials; • Documentation of testing and review for conformity with specifications; • Status: approved / rejected • Master (approved) labels should be maintained for comparison
- 12. Q7: DOCUMENTATION ANDRECORDS (6) E. Batch Production and Control Records (6.5) (i) Actual results recorded for critical process parameters, time, quantity measured, equipment used, sample, (ii) Process parameters- temperature, pressure, pH etc (iii) Signatures of the persons performing and directly supervising or checking each critical step in the operation, (iv) In-process and laboratory test results, (v) Actual yield at appropriate phases or times, vi) Description of packaging and label vii) (vii) Any deviation noted, its evaluation, investigation conducted (if appropriate) or reference to that investigation
- 13. Q7: DOCUMENTATION ANDRECORDS (6) F. Laboratory control records (6.6): Laboratory control recordsshould include complete data derived from all tests conducted to ensure compliance •A description of samples received for testing, including the material name or source, batch number or other distinctive code, date sample was taken, and, where appropriate, the quantity and date the sample was received for testing; •Statement of or reference to each test method used; •Statement of the weight or measure of sample used for each test as described by the method; data on or cross-reference to the preparation and testing of reference standards, reagents and standard solutions; •Complete record of all raw data generated during each test, in addition to graphs, charts and spectra;
- 14. Q7: DOCUMENTATION ANDRECORDS (6) F. Laboratory control records (6.6): contd •A record of all calculations performed in connection with the test, including, for example, units of measure, conversion factors, and equivalency factors; •The signature of the person who performed each test and the date(s) the tests were performed; •The date &signature of a second person who is reviewed for accuracy, completeness, and compliance with established standards. •Complete records should also be maintained for: • Any modifications to an established analytical method; • Periodic calibration of laboratory instruments, apparatus, gauges, and recording devices; • All stability testing performed on APIs; • Out-of-specification (OOS) investigations.
- 15. GMP- Documentation Requirements •Keepin mind, after the product is released and shipped to the customer, what remains behind is the Document. •Documentation / record is useful to us ONLY if it is 100% accurate. •So it is important for us to understand and •follow the Good Record Practice. Records Batch 500507
- 16. Poor documentation Whydo people sometimes fail to document activities or events properly? ??
- 17. Why dopeople sometimes fail to document activities or events properly? People don’t clearly understand what or when to document. Procedures may not be completely understood or followed. People aren’t always held accountable. People will make mistakes. People don’t always make corrections properly. People do not relate records to auditing. People don’t understand the legal role of documentation
- 18. Record Keeping System Howdo maintain the record Bound notebook pre-numbered loose sheets (Pre-numbered, the printing have to be controlled and also the storage as control records) Every register Forms shall have Format / control number / header Date of opening Date of closing Table of content where applicable
- 19. Record writing /DataEntry Enter complete and accurate information at the time work is performed. Enter signature or initials (according to procedure) When one or more person complete the task, all person must sign. Never sign your name for performance of a job for work actually performed by someone else. Limit the use of abbreviations and acronyms.
- 20. Record writing /DataEntry Use Ball point pens of blue or black colored inks to make entries. Don’t use pens like gel pens, ink pens for making entries. Don’t use pens like red, green color ink. Use a non-water soluble pen for writing on any official document.
- 21. Record writing /DataEntry Spaces and cells cannot be left “blank”! When spaces or cells do not contain information, EACH must contain the appropriate “not applicable” entry. Or N/A This rule applies to all product-related documents - electronic and written.
- 22. Record writing /DataEntry Never use ditto Never use lines (with or without arrows) to show a continuation of values or entries in a column or row.
- 23. Record writing /DataEntry Corrections to written records must be made properly. NEVER mask the original entry. NEVER USE “correction” liquid, tape, or material.
- 24. Record writing /DataEntry Corrections to written records must be made properly. DO NOT USE “write- overs” (Don’t turn a “6” or “9” into an “8”.) Never vary your initials or signature
- 25. How to makeCorrections When an entry or calculation must be corrected, follow these steps: •Draw a single line through the incorrect entry. •Enter correct information above or to the side of the incorrect entry. •Write your initials and date of correction. Write justification if possible •When two people signed the original entry, and then another changes the entry, the second person must also sign for the change. Here’s how a corrected entry might look: Weight of ingredient 14.5 kg 14.75 kg Ams 19.08.2016 Don’t Deface the original Entry!
- 26. GDP: Error Description Thefollowing are the example of notations that may be used to describe error corrections. Calculation error Transposition Illegible entry Wrong entry
- 27. GDP: Illegible Clearly Recordthe Data What’s that number? 27? 29? 24? 2% Hmmmm. What do we do now?
- 28. Suppose this isa final product, and the specification is 27 29 is acceptable. But what if it’s 24? Now what? We might have to reject the entire experiment and redo This consumes time and resources. Avoid sloppy writing Similarly try to write in Caps where possible Consequence of illegible writing:
- 29. Good Documentation Practice Computer print outs taken on thermal paper or easily fading inks should be photocopied and maintained. Original shall be destroyed after verification Use polyvinyl alcohol base gum or white glue for pasting of graphs etc Use clear transparent tape for mending (patch-up).
- 30. Good Documentation Practice Don’tdo …. Don’t remove any pages or portions from a note book Don’t make any temporary entries in a bit of paper of hand Preserve the notebooks intact. Do Not Use “Sticky” Notes. Do Not Back-Date Or Post-Date. Do Not Use Asterisks That May Cause Confusion (Such As Using The Same Asterisk For Different Footnotes). Do Not Transcribe Data. Avoid Use of Unbound Laboratory Notebooks
- 31. Recreating And RewritingRecords Recreating or rewriting records should be avoided. If necessary to do this; The supervisor and QA Approvals are required when recreating records. It is important to identify the recreated document as “rewrite” and to reference the sources of the information. Records can be recreated only when: 1. The original record is illegible 2. An incorrect form or document was used 3. The record is reparable 4. The original was in A format that would not keep (thermal paper strips)
- 32. Good Documentation Practice Labrecord: Enter enough details so the document can be understood in the future. Documents should be signed and dated by the person who performed the test. A reference to the identification of the sample analysed should be included.
- 33. Good Documentation Practice Witnessed/ Checked/ reviewed by • The second check : When one person performs the task and the second person verifies that it has been performed correctly. • Double checking our work provides additional assurance that no mistakes were made. • The person who is the “verifier” must be clear as to what they are verifying by affixing their signature to the document. • Examples: charging of raw materials ; Monitoring critical parameters
- 34. Good Documentation Practice Reviewer: Mustbe verified by a second person Signature of the person verified Verify within a time frame Review he documentation: • BPRs, Test record, material issue, Cleaning records, calibration and equipment records, raw data, yield & Calculations etc
- 35. Good Documentation Practice Reviewof the original records when the records are complete / after complete analysis of a sample has been performed. All raw data, all printed / electronic data Chromatogram, spectrum weight prints, This can be done on a sheet/record where all results have been summarized If a notebook is no longer used and unused pages are remaining Draw a line across the first unused page Indicate “the remainder of the note book is not used” Sign with date
- 36. Good Documentation Practice Checkthe following during review: Missing records and out-prints Incomplete entries Illegible corrections Cross References Deviations, if any investigation the impact on the product Valid calibrations and service intervals of test equipment Compliance with specifications, parameter ranges or acceptance criteria including tighter customer specifications
- 37. Good Documentation Practice Examplesof deviations are: Incorrect charging of raw materials. Temperature, pressure, vacuum parameters outside defined limits. Operating instructions not correctly followed. Breakdown of equipment or failure of utilities. Equipment out of calibration. Records not adequately completed. Temporary alteration to defined instructions In Process Control Limits not achieved. Extraneous contamination of API and intermediates Any other unplanned event.
- 38. Good Documentation Practice Errorsor mistakes are possible – person recording is human Correction, corrective action and preventive action List the documentation errors /mistakes/ deviation Classify and trend Train the persons Correction where possible Report the deviation to QA Investigation & root cause Understand issue & take CAPA
- 39. Good Documentation Practice ICHQ7: 6 Documentation And Records 21CFR 211.180(d) …These records or copies…shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph.” Store the documents & records in secured place until retention period Document Retention & Retrieval:
- 40. GDP Implementation Swear torecord the actual information/ data Be honest Strengthen the review Report the deviation Train the operators or chemists on common / identified mistakes or errors
- 41. All this isachievable through Positive attitude Positive thoughts Removal of mental blocks Open or willing to change Understand the need of business Destruction of Ego
- 42. Good Documentation Practice Documentation is a record of our product history. GMP documents are legal documents & requirement. The “double check” (review) assures that our work is correct. All work should be documented at the time work is performed. Correct the errors properly Report the deviations if any and implement the CAPA Train all the staffs on GDP and explain the consequences. Summary
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Editor's Notes
- #16 INSTRUCTOR’S NOTES: Welcome to GMP Training on the topic of Documentation Requirements. We will look at - FDA view of documentation - Specific and UCP documentation practices - and practice proper documentation exercises What is the FDA’s view of documentation? NOT WRITTEN, DIDN’T HAPPEN Documentation includes any records having to do with the manufacture of a drug product from Raw Material arrival to Distribution. What are some examples of records where we document? - Batch Production Recordchange request forms - test resultsdeviation reports - shipping, receiving recordslab notebooks - training records Analytical Data sheets