Good documentation practices


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Good documentation practices

  1. 1. Good Documentation Practices Prepared By ׃ ­Rashid Khan Asst.Manager Quality Assurance
  2. 2. PURPOSE <ul><li>The purpose of good documentation practices is to provide basic guideline and standard ways for correction of errors in documentation </li></ul>
  3. 3. SCOPE <ul><li>This good documentation practices applies to all the documents prepared at Opal Laboratories. </li></ul>
  4. 4. RESPONSIBILITY <ul><li>It is the responsibility of all persons who are involved in preparation, completion or reviewing of documents to implement these practices. </li></ul>
  5. 5. BSIC PRINICIPLES OF DOCUMENTATION <ul><li>Check double check the entries to sort the mistakes in documents. </li></ul><ul><li>Be sure that document is correct and complete prior to forwarding for next process. </li></ul><ul><li>Look at the documentation that essential part of whole job and not as an inconvenience. </li></ul><ul><li>Write each word clearly and legibly. </li></ul><ul><li>Know the procedure for cross-out the wrong word or sentence. </li></ul><ul><li>Never use WHITO/BLANCO . </li></ul><ul><li>Proper completion of documentation is important to ensure the traceability and accountability. </li></ul><ul><li>Every process must be documented. </li></ul><ul><li>Never trust your memory and record all necessary information immediately. </li></ul><ul><li>The work is not completed until it is documented. </li></ul><ul><li>Don’t use pencil on document. </li></ul><ul><li>Back dating on any document is not allowed. </li></ul>
  6. 6. CORRECTION OF WRONG ENTRIES, WRITE OVERS, MISSPELLED WORDS <ul><li>Use a single line to cross out the mistake. </li></ul><ul><li>Never use WHITO/BLANCO. </li></ul><ul><li>Never erase or remove wrong written information. </li></ul><ul><li>Ensure that original entry is still legible. </li></ul><ul><li>Make the correction with initial and dates. </li></ul><ul><li>Write a short explanation, if required. </li></ul><ul><li>Initial must be done on cutting with date. </li></ul><ul><li>If any entry is made wrong in a document for example if batch # of any product is written like 389 instead of 398 then the wrong batch # should be cut as a whole and not partly. It should be initialed and dated. </li></ul><ul><li>38­ 9 -> Wrong practice </li></ul><ul><li>389 -> Correct practice </li></ul><ul><li>In case if an option is given in production BMR such as a.m/p.m, then one option can be omit/cut without any sign. </li></ul><ul><li>Spellings of words in documents are critical especially in case of ingredients, equipments names and technical data. Such information if spelled wrong should be corrected, initialed and dated. </li></ul>
  7. 7. INSTRUCTION <ul><li>Only the person responsible for the error should be notified to correct the error. In case the person is absent or has left the company only then supervisor/ manager of the person responsible for the error should be contacted to do the correction. </li></ul>
  8. 8. USE OF COMMENTS/REMARKS <ul><li>Whenever comments or remarks column is given in the document, comments should be entered with initial and date. </li></ul>
  9. 9. BLANK SPACES <ul><li>No column space, box should be left blank in document. It should be marked as dash (-). </li></ul>
  10. 10. MISSING ENTRIES <ul><li>Missing information in a document should be filled only by a person responsible for the job. It should not be done a second person. If the person responsible is absent or has left the company the supervisor/ Manager of person should fill relevant information along with initial and date. </li></ul>
  11. 11. SIGNATURES AND INITIALS <ul><li>Signatures are required such as BMR, SOP, change control forms, protocols and procedures. In case of working documents Initials can be done such as batch record sheets, in process sheets, QC reports etc. </li></ul>
  12. 12. USE OF INK COLORS <ul><li>Blue ink color should be used by production/ QC/ QA for documentation. It should be used for all entries and signatures on original documents such as master BMR, SOP, Change control form, and protocols to distinguish the original signatures. </li></ul><ul><li>QA should use different color ink such as green to mark errors in batch record sheets while auditing the documents and also during in process checks. </li></ul>
  13. 13. GRAMMER CHECKS <ul><li>If a document such as a log guide or a SOP is under review, corrections related to grammar can be done at this stage. If grammar correction is required in an approved document, it should be done whenever next revision is due. </li></ul>
  14. 14. DATE ENTRY <ul><li>All the dates in a document should be entered in a consistent manner such as DD/MM/YY </li></ul><ul><li>(30-07-2010). </li></ul>
  15. 15. FINAL APPROVALS <ul><li>Final approval in all QC reports such as test reports, stability reports, validation and calibration reports should be dated. </li></ul>
  16. 16. ON TIME ENTRIES <ul><li>All the entries must be completed at the time the task is completed. Don’t depend on memory or memory of others. </li></ul>
  17. 17. FINAL WORDS <ul><li>It is the responsibility of everyone who complete or review a document to ensure its accuracy. </li></ul><ul><li>Documentation error that have not been properly corrected should be reported to the immediate supervisor. </li></ul>
  18. 18. <ul><li>Thank you, </li></ul>
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