Documentation & Batch Documentation Review - Oct 2019
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This document appears to be a presentation on batch documentation review and evaluation. It discusses the importance of batch history for product quality, viability, and safety. It also notes that batch documentation review is important to track operations and identify any errors or deficiencies. The presentation outlines the standard operating procedure and scope for documentation review. It then provides examples of commonly recorded errors and the proper way to correct documentation errors. Finally, it discusses some of the challenges of manual batch documentation recording.
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Documentation & Batch Documentation Review - Oct 2019
- 1. Batch Documentation Review & Evaluation A Last Opportunity to Whistle Roohi B. Obaid 05th Oct 2019, Karachi
- 3. It reflects the views and understanding of presenter & may not be construed to represent the views or policies of organization or association to which speaker has ties Documents of US-FDA, Papers from Pharmaceutical Technology & Review Scientific Articles are used to construct presentation Oliver Wolf, April 2017 Disclaimer Reference
- 4. Batch history is imperative to tracking, sustaining product quality, viability & safety It’s a high risk data It’s a matter of life & lives
- 9. Scope
- 10. The purpose of documentation is limited to tracking and tracing the operation (describe reason for both): Yes No
- 11. Why do we review Batch Record?
- 12. Why we do not believe on real time data? Why do we review Batch Record?
- 13. Why we do not believe on real time data? Why do we review Batch Record? What we expect from Batch Record Review?
- 14. How it is performed?
- 15. Lets have a hypothesis outline to make decision clear & consistent
- 16. Minor health or regulatory suffering Reversible life crisis Irreversible life crisis Limited to discussion on today’s session 2 1 3
- 17. Certificate of Analysis of API Review
- 42. Compression & Packaging Document Review
- 43. Compression & Packaging Document Review
- 44. Compression & Packaging Document Review A
- 45. Compression & Packaging Document Review L
- 46. Compression & Packaging Document Review C
- 47. Compression & Packaging Document Review O
- 48. Compression & Packaging Document Review A
- 49. Compression & Packaging Document Review Complete
- 50. Compression & Packaging Document Review Consistent
- 51. Compression & Packaging Document Review Enduring
- 52. Compression & Packaging Document Review Available
- 54. Bulk Holding Document Review
- 55. Bulk Holding Document Review
- 56. Bulk Holding Document Review A
- 57. Bulk Holding Document Review L
- 58. Bulk Holding Document Review C
- 59. Bulk Holding Document Review O
- 60. Bulk Holding Document Review A
- 61. Bulk Holding Document Review Complete
- 62. Bulk Holding Document Review Consistent
- 63. Bulk Holding Document Review Enduring
- 64. Bulk Holding Document Review Available
- 80. Handwritten change but date of change was not traceable
- 81. Use of ditto mark
- 82. Use of signature stamp
- 83. Ink color is not specified & multi color is used without reason
- 84. Log book correction failed to identify the person who made the change
- 85. Use of pencil
- 86. Traces of erasing pencil marks
- 88. Meta data not available for verification
- 89. Correction of documentation error should include
- 90. Correction of documentation error should include Draw a single line through the error1
- 91. Correction of documentation error should include Draw a single line through the error Make the correction next to the error2 1
- 92. Correction of documentation error should include Draw a single line through the error Make the correction next to the error Write an explanation for the error 2 1 3
- 93. Correction of documentation error should include Draw a single line through the error Signature & date the correction Make the correction next to the error Write an explanation for the error 2 1 4 3
- 95. Manual recording are inherently slow & prone to error
- 96. Manual recording are inherently slow & prone to error Incorrect data entry
- 97. Manual recording are inherently slow & prone to error Blindness & failure to recognize OOS Incorrect data entry
- 98. Manual recording are inherently slow & prone to error Blindness & failure to recognize OOS Missing signatures Incorrect data entry
- 99. Manual recording are inherently slow & prone to error Blindness & failure to recognize OOS Missing signatures Used incorrect form Incorrect data entry
- 100. Manual recording are inherently slow & prone to error Blindness & failure to recognize OOS Sending wrong form to wrong person Missing signatures Used incorrect form Incorrect data entry
- 101. Manual recording are inherently slow & prone to error Blindness & failure to recognize OOS Sending wrong form to wrong person Missing signatures Used incorrect form Incorrect data entry Form left incomplete
- 102. Data located in separate positions
- 103. What documentation was missed & what reviews missed. List the deficiencies Pakistan 150 deaths case
- 104. Thank You