Documentation refers to the records of various events throughout the process of pharmaceutical manufacturing. In reality, however, this term is much broader. Properly organized documentation system enables a company to recreate any operations, monitor who performed a specific operation, trace ways of how this operation had been accomplished and assess if and how this operation was done in a validated condition.
Consequently, a lack of documentation may lead to compliance issues even if the actual manufacturing process was done properly.
During GMP inspections, inspectors often compare the employees’ narratives about what happened with the data contained in the controlled documents. An entry that is missing, an entry that was changed without being supported by any explanation, an entry that lacks a signature, an undocumented operation or a mismatch between two documents may signal a threat to data integrity and to Qualcomm pharmaceutical product delivery quality system.
The crucial detail is that a lack of documentation is not merely a paperwork flaw. Its degree of seriousness will depend on what exactly is missing and whether this missing information impacts the quality of goods, traceability or possibility to recreate the event in question.
Some examples of documentation gaps are:
The common oversights are omissions of:
There can be deficiencies, such as:
Here are some of the factors that contribute to them.
1. Poorly constructed forms: Confusing or repetitive forms or forms that do not clearly state what data should be collected are likely to result in errors from operators.
2. Lack of training: Employees may know how to do their job, but not know how to fill out the required documentation.
3. Time pressure: People might just postpone documentation or leave out information because of stress caused by having too much work.
4. Poor oversight: Supervision of the documentation process that focus only on signatures and not on the quality of the documentation will only perpetuate the problems.
5. Continuous changes in procedures: Changing the SOPs and forms without proper training, explaining these changes to the workers or timing can create confusion.
6. Retrospective documentation: Sometimes, when entries are missed, employees rely on their memory when making entries.
1. Attribution
2. Legibility
3. Conductivity
4. Originality
5. Accuracy
However, current guidelines of GMP interpret these principles more broadly leading to the emergence of the terms “completeness of data,” “consistency of data,” “endurance of data,” and “availability of data.”
For example, if a person executes an operation at 10:00 AM but refers to the operation at 2:00 PM based on his/her memory later on, it is doubtful that such an entry can be regarded as contemporaneous documentation.
Changing the original document without preserving the original information is also damaging to the reliability of the document.
Thus, good practice can consist of documenting information simultaneously with the activity executed in accordance with proper procedures.
The investigation should try to answer the following questions:
Nonetheless, the evidence should never be used to create or backdate records in any way. The goal is to establish what can be verified in a reliable way.
The justification for the correction should be documented where needed according to procedures or based on risk. The correction process must not:
Useful preventive actions can be the following:
Inspectors may conduct comparisons between the following types of records:
1) Standard operating procedures and how they are applied in practice
2) Batch production records and any relevant logbooks
3) Lab samples and relevant record documentation
4) Staff training records and any relevant job roles
5) Cleaning and sanitization records and any relevant equipment use
6) Maintenance records with any relevant production activities
It is worth noting that the difference between two independent documents may bear more significance than the presence of an isolated defect because it may give rise to questions concerning the reliability of records.
This is why it is important to treat documentation as an interconnected system instead of a number of independent forms.
1. Detection: Find omissions, deficiencies or inconsistency in documentation.
2. Assessment: Understand the probable implications for product quality, patient safety, traceability and reliability of the data.
3. Investigation: Confirm the circumstances based on reliable evidence.
4. Correction: Rectify the problem according to the established documentation process.
5. Root cause identification: Find out if it was a people, process, form, system, workload or supervision issue.
6. Corrective action plan implementation: Take action to eliminate any present causes.
7. Trends: Avoid repeating the same mistake.
This approach enables organizations not to view every documentation failure as a simple human mistake.
Documentation deficiencies are one of the most obvious shortcomings of a pharmaceutical GMP system. The records are the proof that operations took place correctly.
The solution is not just to instruct the staff to "be more careful." Organizations require there to be accurately laid out documents, practical training, efficient control, correct technical management, timely assessment and meaningful investigations into repeated mistakes.
In the best quality systems, the most effective documentation is achieved in a natural way, as a part of the process. Workers understand why it is necessary to document, documents are filled in when events are occurring, documentation is inspected in detail by those who are responsible and repeated mistakes are thoroughly investigated.
In the end, the quality GMP records make it possible for someone with the proper qualifications to understand what has been done, when it was done and by whom without any guesses or assumptions.
During GMP inspections, inspectors often compare the employees’ narratives about what happened with the data contained in the controlled documents. An entry that is missing, an entry that was changed without being supported by any explanation, an entry that lacks a signature, an undocumented operation or a mismatch between two documents may signal a threat to data integrity and to Qualcomm pharmaceutical product delivery quality system.
The crucial detail is that a lack of documentation is not merely a paperwork flaw. Its degree of seriousness will depend on what exactly is missing and whether this missing information impacts the quality of goods, traceability or possibility to recreate the event in question.
What Is a Documentation Gap?
A documentation gap refers to the absence of essential information or some information being incomplete, inconsistent, inaccurate or not recorded correctly.Some examples of documentation gaps are:
- Missing initials or signatures
- Missing activities
- Incomplete records
- Incorrect times
- Missing equipment information
- Changes that are not clear
- Empty spaces without justification
- Missing reviews
- Conflicting entries in documents
- Recording an action after the fact
- Old forms or processes used
Places Where Documentation Mistakes Happen
Documentation mistakes can happen in various parts of the drug quality system.1. Manufacturing Records
Batch Manufacturing Documentation (BMD) and Batch Packing Documentation are very significant because they record the real manufacturing experience.The common oversights are omissions of:
- Equipment indices
- Material amounts
- Changeover times
- Operator initials
- Validation signatures
- Product measurement
- Line clearance documentation
- In-process testing data
2. Laboratory Records
QC records are sometimes incomplete, including:- Raw analytical data
- Sample preparation details
- Equipment identification
- Information regarding the preparation of the standards
- Calculations
- Systems suitability test
- Signature of the analyst
- Records of review of information
3. Equipment and Logs
Equipment logs should keep reliable accounts of the machine usage and events like important interventions.There can be deficiencies, such as:
- Absence of entries regarding equipment usage
- Failure to record cleaning
- Missing maintenance records
- Random times of equipment inactivity
- Absence of calibration records
- Unclear status identification
Reasons for Documentation Gaps
There is almost never a single reason for documentation issues.Here are some of the factors that contribute to them.
1. Poorly constructed forms: Confusing or repetitive forms or forms that do not clearly state what data should be collected are likely to result in errors from operators.
2. Lack of training: Employees may know how to do their job, but not know how to fill out the required documentation.
3. Time pressure: People might just postpone documentation or leave out information because of stress caused by having too much work.
4. Poor oversight: Supervision of the documentation process that focus only on signatures and not on the quality of the documentation will only perpetuate the problems.
5. Continuous changes in procedures: Changing the SOPs and forms without proper training, explaining these changes to the workers or timing can create confusion.
6. Retrospective documentation: Sometimes, when entries are missed, employees rely on their memory when making entries.
Documentation Gaps and Data Integrity
The matter of documentation gaps has a strong relationship with basic principles of data integrity according to ALCOA. The following principles are defined by ALCOA:1. Attribution
2. Legibility
3. Conductivity
4. Originality
5. Accuracy
However, current guidelines of GMP interpret these principles more broadly leading to the emergence of the terms “completeness of data,” “consistency of data,” “endurance of data,” and “availability of data.”
For example, if a person executes an operation at 10:00 AM but refers to the operation at 2:00 PM based on his/her memory later on, it is doubtful that such an entry can be regarded as contemporaneous documentation.
Changing the original document without preserving the original information is also damaging to the reliability of the document.
Thus, good practice can consist of documenting information simultaneously with the activity executed in accordance with proper procedures.
How to Investigate a Documentation Gap
One should not assume that a documentation gap can be resolved simply by asking an employee to fill in the void in the records. The first step should be to establish what happened.The investigation should try to answer the following questions:
- Which information is missing?
- When should that information have been recorded?
- Who was in charge?
- Is there independent evidence available?
- Will the missing information have an effect on product quality?
- Is the integrity of the data compromised in any way?
- Has the same situation happened before?
- Is the procedure clearly spelling out the documentation requirement?
Nonetheless, the evidence should never be used to create or backdate records in any way. The goal is to establish what can be verified in a reliable way.
Correcting Documentation Errors
GMP document error corrections must adhere to the appropriate process. In general, its objective is to preserve the original information, input the correct information and identify the person correcting it.The justification for the correction should be documented where needed according to procedures or based on risk. The correction process must not:
- Obscure the original source
- Be dated retrospectively
- Use correction fluid
- Be done by someone else without justification
- Leave doubt in what actually happened
Preventing Recurring Documentation Gaps
The solution must try to speak to the root cause of the problem instead of retraining employees alone.Useful preventive actions can be the following:
1. Improvement of the Design of Forms
Forms should clearly show which information is required. It is important to make the main fields happen on the foreground.2. Training Upgrade
Training must provide real examples of both acceptable and unacceptable documentation rather than rely only on theories.3. Improvement of Updating Procedures
It is important for managers to find out mistakes in documentation immediately rather than wait until the batch-record review.4. Use of Controls in Electronic File Systems
Help from validated electronic systems is valued, as they provide alerts, obligatory fields, controlled flow of information and auditing features.5. Registering Repetitive Cases of Documentation Errors
Any organization must find work the possible reasons for repeated documentation mistakes to get the idea of what is happening in terms of reporting errors caused by:- Department
- Process
- Form
- Employee group
- Type of mistake
- Frequency of case
What Inspectors May Look For
As part of the inspection process, it is common to assess various examples of documentation in relation to how they were actually applied in practice.Inspectors may conduct comparisons between the following types of records:
1) Standard operating procedures and how they are applied in practice
2) Batch production records and any relevant logbooks
3) Lab samples and relevant record documentation
4) Staff training records and any relevant job roles
5) Cleaning and sanitization records and any relevant equipment use
6) Maintenance records with any relevant production activities
It is worth noting that the difference between two independent documents may bear more significance than the presence of an isolated defect because it may give rise to questions concerning the reliability of records.
This is why it is important to treat documentation as an interconnected system instead of a number of independent forms.
A Practical Approach to Closing Documentation Gaps
A well-established organization in the field of pharmaceuticals has to use a systematic approach:1. Detection: Find omissions, deficiencies or inconsistency in documentation.
2. Assessment: Understand the probable implications for product quality, patient safety, traceability and reliability of the data.
3. Investigation: Confirm the circumstances based on reliable evidence.
4. Correction: Rectify the problem according to the established documentation process.
5. Root cause identification: Find out if it was a people, process, form, system, workload or supervision issue.
6. Corrective action plan implementation: Take action to eliminate any present causes.
7. Trends: Avoid repeating the same mistake.
This approach enables organizations not to view every documentation failure as a simple human mistake.
Documentation deficiencies are one of the most obvious shortcomings of a pharmaceutical GMP system. The records are the proof that operations took place correctly.
The solution is not just to instruct the staff to "be more careful." Organizations require there to be accurately laid out documents, practical training, efficient control, correct technical management, timely assessment and meaningful investigations into repeated mistakes.
In the best quality systems, the most effective documentation is achieved in a natural way, as a part of the process. Workers understand why it is necessary to document, documents are filled in when events are occurring, documentation is inspected in detail by those who are responsible and repeated mistakes are thoroughly investigated.
In the end, the quality GMP records make it possible for someone with the proper qualifications to understand what has been done, when it was done and by whom without any guesses or assumptions.
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