GMP - GOOD DOCUMENTATION PRACTICES
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The document outlines good documentation practices (GDP) required for quality management systems (QMS) and Good Manufacturing Practice (GMP). It emphasizes the importance of clear, accurate, and precise documentation methods, including various prohibitions on materials and practices such as the use of erasable ink and correction fluid. Key responsibilities for adherence and oversight are assigned to department heads and quality assurance personnel.
GMP - GOOD DOCUMENTATION PRACTICES
- 1. WHY??? 1 GOOD DOCUMENTATION PRACTICES Because, If you did not document it, it did not happen! QMS & GMP REQUIREMENT
- 2. Describe: • Methods of recording of data • Rectification of written data Includes: • Documentation on paper • In electronic form • Photocopy of another document 2 GOOD DOCUMENTATION PRACTICES
- 3. SOP is applicable to: • Master documents • Records being maintained • Training, validations, qualifications, calibrations and maintenance of manufacturing equipment & utility systems, etc. 3 GOOD DOCUMENTATION PRACTICES
- 4. Responsibility: • Department heads Strict adherence of personnel to GDP • Executive QA / designee Monitoring of documentation procedures • Head quality Overall control over documentation 4 GOOD DOCUMENTATION PRACTICES
- 5. 5 GOOD DOCUMENTATION PRACTICES Document should be: • Clear • Precise • Accurate • Legible • Unambiguous Prohibitions • Erasable ink • Correction fluid • Use of Pencils
- 6. GOOD DOCUMENTATION PRACTICES CLEARLY RECORD THE DATA What is that? 29? 27? No I think its 24? Ummm.. What do we do now???
- 7. 7 GOOD DOCUMENTATION PRACTICES When Documenting: • Direct transcription onto Document • Legible writing • Blue indelible ball point pen • Put initials to authenticate • Justify overwriting • Date format: DD/MM/YYYY • Time format: 24:00 Hrs …
- 8. 8 GOOD DOCUMENTATION PRACTICES When Documenting: • No rounding off in BOM & Dispensing records • Documents with boxes or spaces: Each one will be completed without exception, If not applicable: ‘-’ or ‘NA’ as appropriate • Data in margin: Initialed, dated and linked to respective data …
- 9. 9 GOOD DOCUMENTATION PRACTICES When Documenting: • Page/ part of page not applicable Diagonally cross, sign and date • Data to be repeated: Write it, No ditto signs • Do not write on backside of page • No Backdating
- 10. 10 GOOD DOCUMENTATION PRACTICES Annexure or attachment: • Initialed and signed • Reference No. of principle document • Filed or affixed with principle document • Binary page numbering system “Page X of Y”
- 11. 11 GOOD DOCUMENTATION PRACTICES Photocopying: • Same record to be used for several documents • Original record not immediately available • No hiding of information while photocopying • Reference No. of original document
- 12. 12 GOOD DOCUMENTATION PRACTICES Rectification of Data: No modification without QA approval To be done by person who recorded or supervisor Blue indelible ball point pen Strikethrough with single line DATA Allow easy reading of cancelled data Prohibitions: •Erasable ink •Correction fluid •Use of Pencils
- 13. 13 GOOD DOCUMENTATION PRACTICES Rectification of Data: • Corrected information Near as possible to the crossed out information Initialed and dated Brief but clear explanation • Insufficient space Use blank space on page Link by distinctive sign * …
- 14. 14 Rectification of Data: • Numerous corrections or spoilt document Re-transcript on new document after QA approval Initial document to be attached to new document New document shall bear following remark: "Document recopied from the original attached in annex". By : and after acceptance by Quality Assurance Date : Sign : GOOD DOCUMENTATION PRACTICES
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Editor's Notes
- #3: PIC/S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS
- #16: REFERENCES: QAD-005 Title: Good Documentation Practices WHO technical report series 823 (Thirty second report) Eudralex “The Rules Governing Medicinal Products in the European union” Volume 4. ABBREVIATIONS: SOP Standard operating procedure No. Number e.g. Example NA Not Applicable EU European Union WHO World Health Organization Sign Signature