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Controlled Contamination Service

Good Documentation Practices (GDP)

Implementing QR Code for GDP Improvement

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Executive Summary

Good Documentation Practices (GDP) are the measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.

Compliant documentation builds confidence in the quality assurance system and practice. GDP ensures there is traceability in what is being documented. This process is useful for reviews and investigations. A reduction in assumptions/second guessing around procedures that are carried out by the CCS team is also a result of this process. Effective documentation practices provided consistent quality, performance of staff, and specifies clear instructions on what has been accomplished with the controlled environment.

Poor Documentation Practices Include:

  • Missing signatures and dates at the time an activity was performed
  • Non-uniform date and signature
  • Activities performed on one day and signed for on another day.
  • Illegible handwriting
  • Too many corrections & missing reasoning within corrections
  • Spaces being left blank and using white out or other masking devices

Errors made during the documentation of an activity require an explanation to allow anyone reviewing the document to understand what occurred. GDP expectations and requirements for GMP facilities are implemented per Code of Federal Regulations (CFR), and client Standard Operating Procedure (SOP) requirements.

As CCS works to provide highly specialized services to its partners there is also a focus on ensuring routine established processes are failsafe to keep your site production capable. CCS biotech and pharmaceutical partners reported continual GDP (Good Documentation Practice) issues including missing entries, improper entries, and corrections.

CCS first addressed this by providing retraining on how to properly review logbooks. QA and IT also created a GDP tracker where all errors found on client controlled logbooks and corrections made in logbooks are recorded to increase visibility into site documentation. Together, we created a QR code that supervisors can use to track a procedure to review client logbooks and perform any corrections. The QR code GDP tracker does not act as a replacement of the client-controlled cleaning log books but is rather considered a supplement to that documentation.

In the following months, the clients noted a significant reduction in GDP errors.

Executive Summary

Good Documentation Practices (GDP) are the measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.

Compliant documentation builds confidence in the quality assurance system and practice. GDP ensures there is traceability in what is being documented. This process is useful for reviews and investigations. A reduction in assumptions/second guessing around procedures that are carried out by the CCS team is also a result of this process. Effective documentation practices provided consistent quality, performance of staff, and specifies clear instructions on what has been accomplished with the controlled environment.

Poor Documentation Practices Include:

  • Missing signatures and dates at the time an activity was performed
  • Non-uniform date and signature
  • Activities performed on one day and signed for on another day.
  • Illegible handwriting
  • Too many corrections & missing reasoning within corrections
  • Spaces being left blank and using white out or other masking devices

Errors made during the documentation of an activity require an explanation to allow anyone reviewing the document to understand what occurred. GDP expectations and requirements for GMP facilities are implemented per Code of Federal Regulations (CFR), and client Standard Operating Procedure (SOP) requirements.

As CCS works to provide highly specialized services to its partners there is also a focus on ensuring routine established processes are failsafe to keep your site production capable. CCS biotech and pharmaceutical partners reported continual GDP (Good Documentation Practice) issues including missing entries, improper entries, and corrections.

CCS first addressed this by providing retraining on how to properly review logbooks. QA and IT also created a GDP tracker where all errors found on client controlled logbooks and corrections made in logbooks are recorded to increase visibility into site documentation. Together, we created a QR code that supervisors can use to track a procedure to review client logbooks and perform any corrections. The QR code GDP tracker does not act as a replacement of the client-controlled cleaning log books but is rather considered a supplement to that documentation.

In the following months, the clients noted a significant reduction in GDP errors.

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