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Good Documentation Practices

Good manufacturing practices.

ganeshgaonkar
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Good Documentation Practices

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  1. Good Documentation Practices

  2. Documents: Is the official record or report which supports and /or records the activities for development,inspection,testing handling and distribution of raw materials,inprocess materials and finished product. Logs, protocols,repors,etc..

  3. Verified by : Person other than the original person who performs or documents the specific function, task or steps should be verify.

  4. General Criteria : • All documents should be designed,prepared,reviewed and distributed as per current versions. • Document should be approved, signed and dated by the concerned authorized signatories.

  5. All entries must be made only in blue ball pen. • All entries must be legible • All entries should be signed.

  6. NO entry shall be over written. • Ditto marks are not acceptable • All the document / records should have page numbers.

  7. GMP record should not be discarded for any reason unless the retention period expiry is reached. • If s decimal value is fraction of 1 then a zero must be placed before the decimal point. Example: record 0.55 rather than .55.

  8. When a date is recorded, the acceptable format is DD/MM/YY only. • Time is recorded in 24:00 hour time.

  9. Requirements for correction, unused spaces and data transcription. • Strike off the entire entry. DO NOT obliterate the original entry. • If the reason for NA is not clearly evident, a comment/justification must be provided.

  10. All transcribed entries have to be verified for accuracy and correctness by lead personnel. • All unused spaces in the documents should be clearly addressed by writing NA in the unused space.

  11. Reference : • WHO guideline (good data and record management practices) • ISO/IEC 27001 Information security management • MHRA (Good Manufacturing Practice Medicinal Products for Human and Veterinary Use) • USFDA (Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry)

  12. If you want Full GMP??? Soft copy of SOP = 1.5$ (US dollar) (110 Indian rupee) Annexure per copy = 0.7$ (US dollar) (50 Indian Rupee) Contact : Email: gnccmysore@gmail.com Telegram:+919738137533 (only for Chat)

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