Good documentation practice (GDocP) is a set of internationally accepted guidelines that ensure the integrity and reliability of the data collected during the research, development, manufacturing, and testing of drugs and medical devices. Learn about good documentation practices with this starter Qstream microlearning course.
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Answer explanation:
“If it isn’t documented, it didn’t happen.” is an effective and easy way to remind yourself to document all activities that need to be recorded. Documentation provides written proof that something happened. Documents are approved instructions, either in paper or digital form, which guide workers towards how an activity shall be executed. This includes all activities you have performed in the past. It does not include activities you plan to do in the future, or that may eventually happen.
Records provide evidence that activities have been performed or results have been achieved. A record is typically considered a document.
Learn More:
Explore why Good Documentation Practices are important, what constitutes good documentation, and more with this 5-minute video:
Answer explanation:
Workers will fail to record activities properly if they do not completely understand the procedures to follow, such as what, when, and how to record.
Adhering to Good Documentation Practices (GDocP) eliminates these assumptions by providing clear procedures that are easy for workers to follow. If there is a mistake, employees need to be held accountable so they can understand what the expectation is when recording events or activities.
If workers see documentation as a waste of time and effort that does not relate to legal or business needs, they will likely not dedicate the amount of time and attention it deserves. This may lead to more and/or avoidable mistakes happening. Although mistakes will inevitably occur, the goal of adhering to GDocP is to minimize them as much as possible.
Answer explanation:
The bottom line is that Good Documentation Practices need to be complete and authentic. This includes being:
• True: It is a record of what actually happened
• Accurate: It is precise and error-free
• Timely: It is documented at the time when the activity is done
• Legible: It is readable and able to be understood
• Concise: The information is brief and clear
• Traceable: Who recorded it, where, when, and how is identified
• Enduring: The record is long-lasting and durable
• Accessible: The document is easily available and retrievable
The document can be either in analog (i.e., paper), digital (i.e., computer), or both forms.
Answer explanation:
Good Documentation Practices (GDocP) provides Tyler’s staff with the confidence to know what to do while eliminating assumptions and the need to re-ask the same questions because the instructions are clear and well understood. GDocP not only helps Tyler’s staff to meet the needs of their customers but also that of their stakeholders. Both of these benefits support a thriving business.
Finally, Tyler discusses with his team how GDocP supports consistent quality, yield, and staff performance. While all mistakes won’t be eliminated, they can be avoided. GDocP will ensure correct, complete, current, and consistent information that can be useful in product and process reviews.
Answer explanation:
Following Good Documentation Practices, the records and reports related to production events produced by Mary and her team represent the only official documented record of activities. These include:
• Processing a batch or producing a device
• The final decision to release or reject a batch or product
• The evidence of a corrective or preventive action
• An investigation of manufacturing deviations, complaints, or alleged product defects
Activities that do not need to be documented include those that are not related to production such as where you take personal breaks or a meeting that will happen in the future.
Questions written for this Qstream are based on content from:
1. https://www.fdanews.com/ext/resources/files/marketing_files/cGMP-Meeting-Series-021215.pdf
2. https://www.pharmaguideline.com/2014/07/requirements-for-good-documentation-practice-gdp.html,
3. https://www.slideshare.net/DrAmsavelvel/good-documentation-practice-88810012
4. https://www.msbdocs.com/21-cfr-part-11-and-good-documentation-practices-in-pharmaceutical-industries
5. https://atsautomation.com/wp-content/uploads/sites/9/2020/06/2_14_4_006-Good-Documentation-Practices.pdf
Answer explanation:
Good Documentation Practices (GDocP) applies to all workers who document activities related to good manufacturing processes. This includes compliance with the U.S. Food and Drug Administration’s (FDA’s) regulations (21 CFR Part 58) as well as regulations for drugs and medical devices (21 CFR Parts 211 and 820).
Other regulatory agencies that enforce GDocP are:
• World Health Organization (WHO)
• European Medicines Agency (EMA)
• Therapeutic Goods Administration (TGA)
• Health Canada
Learn More:
Review this 5-minute article for a quick overview of Good Document Practices regulations.
[https://www.fdanews.com/ext/resources/files/marketing_files/cGMP-Meeting-Series-021215.pdf]
Answer explanation:
Documents that require workers to follow Good Documentation Practices include:
• Analytical Methods
• Batch Records
• Bill of Materials (BOMs)
• Certificate of Analyses (CoA)
• Certificate of Compliance (CoC)
• Laboratory Notebooks
• Logbooks
• Policies
• Protocols
• Quality Control Records
• Standard Operating Procedures
• Test Methods
• Training Documentation
• Validation Documents (IQs, OQs and PQs)
• Work Instructions
• Product and Sample Labels
Learn More:
Review the document types related to GDocP as well as other topics in this 5-minute slide deck: Good Documentation Practices
[https://atsautomation.com/wp-content/uploads/sites/9/2020/06/2_14_4_006-Good-Documentation-Practices.pdf]
Answer explanation:
The categories of documents that need to follow Good Documentation Practices include:
• Primary Records: Records from the master formula, manufacturing process, and packaging instructions.
• Subsidiary Records: Records that support a process as it is being carried out, such as preventive maintenance on lab equipment.
• Supporting Procedures: Procedures on the instructions for performing a manufacturing sequence or test methodology.
• Quality Control Records: Records such as all lab testing results as well as investigative reports and records.
Answer explanation:
By following Good Documentation Practices when signing a document, you confirm your unique identity by matching your name with your signature. This is especially important in large organizations, where there may be multiple people who have the same name; however, their signatures will be unique.
Also, your signature states that you have the authorization to perform, verify, check, review, or approve the activity that you have signed. Once signed, you are personally, professionally, and legally responsible for the activity you have signed and you cannot undo your signature.
Your signature and initials must be recorded in a signature logbook so that they can be cross-referenced to your name by anyone reviewing the documentation.
Answer explanation:
When adhering to Good Documentation Practices (GDocP), workers need to avoid doing specific actions that violate GDocP principles. Activities to avoid include:
• Destroying documents with original signatures
• Falsifying information
• Obliterating a record
• Overwriting a digital record
• Using a pencil or other non-permanent writing tool
• Leaving a form field, line, or space blank
• Using symbols (i.e., “, ->) to indicate repetitive or consecutive entries
Learn More:
Review how to properly correct mistakes in records, as well as review related topics, in this 10-minute slide deck on Good Documentation Practices.
[https://www.slideshare.net/DrAmsavelvel/good-documentation-practice-88810012]
Answer explanation:
When following Good Documentation Practices, the date should be recorded in DD.MM.YYYY. In this case, March 7th, 2020 is recorded as 07.03.2020. Use a “0” before the digit if the number is less than 10 for the month or day.
Additionally, the time should be recorded in the 24-hour format, specifically HH:MM. In this case, 2:35 pm is recorded as 14:35, while 2:35 am would be recorded as 02:35.
Answer explanation:
When following Good Documentation Practices, it is important to take care and use standard conventions when documenting to ensure what is written is legible. A document is unusable if it cannot be read and there are serious consequences when the writing of a document is illegible.
For example, time and resources can be wasted if experiments or production runs are rejected due to illegible writing. A worst-case scenario would be products going to market that cause serious harm or even death because the related records contained writing that was mistakenly interpreted incorrectly.
Characters that frequently cause interpretation problems in legibility include:
• 4 and 9
• 0 and 6
• U and V
• S and 5
• B and 8
Answer explanation:
Good Documentation Practices state that tasks need to be documented immediately after they are performed. Although there is not an exact definition of “immediately after” in terms of how many minutes are allowed, records should never be pre-dated or post-dated. All records should be made on the date they were performed.
Answer explanation:
“If it isn’t documented, it didn’t happen.” is an effective and easy way to remind yourself to document all activities that need to be recorded. Documentation provides written proof that something happened. Documents are approved instructions, either in paper or digital form, which guide workers towards how an activity shall be executed. This includes all activities you have performed in the past. It does not include activities you plan to do in the future, or that may eventually happen.
Records provide evidence that activities have been performed or results have been achieved. A record is typically considered a document.
Learn More:
Explore why Good Documentation Practices are important, what constitutes good documentation, and more with this 5-minute video:
Answer explanation:
Workers will fail to record activities properly if they do not completely understand the procedures to follow, such as what, when, and how to record.
Adhering to Good Documentation Practices (GDocP) eliminates these assumptions by providing clear procedures that are easy for workers to follow. If there is a mistake, employees need to be held accountable so they can understand what the expectation is when recording events or activities.
If workers see documentation as a waste of time and effort that does not relate to legal or business needs, they will likely not dedicate the amount of time and attention it deserves. This may lead to more and/or avoidable mistakes happening. Although mistakes will inevitably occur, the goal of adhering to GDocP is to minimize them as much as possible.
Answer explanation:
The bottom line is that Good Documentation Practices need to be complete and authentic. This includes being:
• True: It is a record of what actually happened
• Accurate: It is precise and error-free
• Timely: It is documented at the time when the activity is done
• Legible: It is readable and able to be understood
• Concise: The information is brief and clear
• Traceable: Who recorded it, where, when, and how is identified
• Enduring: The record is long-lasting and durable
• Accessible: The document is easily available and retrievable
The document can be either in analog (i.e., paper), digital (i.e., computer), or both forms.
Answer explanation:
Good Documentation Practices (GDocP) provides Tyler’s staff with the confidence to know what to do while eliminating assumptions and the need to re-ask the same questions because the instructions are clear and well understood. GDocP not only helps Tyler’s staff to meet the needs of their customers but also that of their stakeholders. Both of these benefits support a thriving business.
Finally, Tyler discusses with his team how GDocP supports consistent quality, yield, and staff performance. While all mistakes won’t be eliminated, they can be avoided. GDocP will ensure correct, complete, current, and consistent information that can be useful in product and process reviews.
Answer explanation:
Following Good Documentation Practices, the records and reports related to production events produced by Mary and her team represent the only official documented record of activities. These include:
• Processing a batch or producing a device
• The final decision to release or reject a batch or product
• The evidence of a corrective or preventive action
• An investigation of manufacturing deviations, complaints, or alleged product defects
Activities that do not need to be documented include those that are not related to production such as where you take personal breaks or a meeting that will happen in the future.
Questions written for this Qstream are based on content from:
1. https://www.fdanews.com/ext/resources/files/marketing_files/cGMP-Meeting-Series-021215.pdf
2. https://www.pharmaguideline.com/2014/07/requirements-for-good-documentation-practice-gdp.html,
3. https://www.slideshare.net/DrAmsavelvel/good-documentation-practice-88810012
4. https://www.msbdocs.com/21-cfr-part-11-and-good-documentation-practices-in-pharmaceutical-industries
5. https://atsautomation.com/wp-content/uploads/sites/9/2020/06/2_14_4_006-Good-Documentation-Practices.pdf
Answer explanation:
Good Documentation Practices (GDocP) applies to all workers who document activities related to good manufacturing processes. This includes compliance with the U.S. Food and Drug Administration’s (FDA’s) regulations (21 CFR Part 58) as well as regulations for drugs and medical devices (21 CFR Parts 211 and 820).
Other regulatory agencies that enforce GDocP are:
• World Health Organization (WHO)
• European Medicines Agency (EMA)
• Therapeutic Goods Administration (TGA)
• Health Canada
Learn More:
Review this 5-minute article for a quick overview of Good Document Practices regulations.
[https://www.fdanews.com/ext/resources/files/marketing_files/cGMP-Meeting-Series-021215.pdf]
Answer explanation:
Documents that require workers to follow Good Documentation Practices include:
• Analytical Methods
• Batch Records
• Bill of Materials (BOMs)
• Certificate of Analyses (CoA)
• Certificate of Compliance (CoC)
• Laboratory Notebooks
• Logbooks
• Policies
• Protocols
• Quality Control Records
• Standard Operating Procedures
• Test Methods
• Training Documentation
• Validation Documents (IQs, OQs and PQs)
• Work Instructions
• Product and Sample Labels
Learn More:
Review the document types related to GDocP as well as other topics in this 5-minute slide deck: Good Documentation Practices
[https://atsautomation.com/wp-content/uploads/sites/9/2020/06/2_14_4_006-Good-Documentation-Practices.pdf]
Answer explanation:
The categories of documents that need to follow Good Documentation Practices include:
• Primary Records: Records from the master formula, manufacturing process, and packaging instructions.
• Subsidiary Records: Records that support a process as it is being carried out, such as preventive maintenance on lab equipment.
• Supporting Procedures: Procedures on the instructions for performing a manufacturing sequence or test methodology.
• Quality Control Records: Records such as all lab testing results as well as investigative reports and records.
Answer explanation:
By following Good Documentation Practices when signing a document, you confirm your unique identity by matching your name with your signature. This is especially important in large organizations, where there may be multiple people who have the same name; however, their signatures will be unique.
Also, your signature states that you have the authorization to perform, verify, check, review, or approve the activity that you have signed. Once signed, you are personally, professionally, and legally responsible for the activity you have signed and you cannot undo your signature.
Your signature and initials must be recorded in a signature logbook so that they can be cross-referenced to your name by anyone reviewing the documentation.
Answer explanation:
When adhering to Good Documentation Practices (GDocP), workers need to avoid doing specific actions that violate GDocP principles. Activities to avoid include:
• Destroying documents with original signatures
• Falsifying information
• Obliterating a record
• Overwriting a digital record
• Using a pencil or other non-permanent writing tool
• Leaving a form field, line, or space blank
• Using symbols (i.e., “, ->) to indicate repetitive or consecutive entries
Learn More:
Review how to properly correct mistakes in records, as well as review related topics, in this 10-minute slide deck on Good Documentation Practices.
[https://www.slideshare.net/DrAmsavelvel/good-documentation-practice-88810012]
Answer explanation:
When following Good Documentation Practices, the date should be recorded in DD.MM.YYYY. In this case, March 7th, 2020 is recorded as 07.03.2020. Use a “0” before the digit if the number is less than 10 for the month or day.
Additionally, the time should be recorded in the 24-hour format, specifically HH:MM. In this case, 2:35 pm is recorded as 14:35, while 2:35 am would be recorded as 02:35.
Answer explanation:
When following Good Documentation Practices, it is important to take care and use standard conventions when documenting to ensure what is written is legible. A document is unusable if it cannot be read and there are serious consequences when the writing of a document is illegible.
For example, time and resources can be wasted if experiments or production runs are rejected due to illegible writing. A worst-case scenario would be products going to market that cause serious harm or even death because the related records contained writing that was mistakenly interpreted incorrectly.
Characters that frequently cause interpretation problems in legibility include:
• 4 and 9
• 0 and 6
• U and V
• S and 5
• B and 8
Answer explanation:
Good Documentation Practices state that tasks need to be documented immediately after they are performed. Although there is not an exact definition of “immediately after” in terms of how many minutes are allowed, records should never be pre-dated or post-dated. All records should be made on the date they were performed.
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