Every healthcare industry deals with Good Documentation Practices (GDP) inside the organization to lead the outside market of high-quality drugs or medical devices. The procedures also include a high level of documentation activities to make sure they are audit-ready and have trace-able records.
During recent years especially in India, healthcare industries frequently received warning letters for data integrity issues resulting in huge losses for example:
1. Restrictions imposed by regulatory bodies such as WHO, FDA, etc.
2. Inability to respond to agencies due to lack of traceability in the organization
3. Hampered reputation in the market
4. Loss of customer faith
5. Questions on the marketed product
6. Loss in trades and share market
They’re permanent stigma to the well-established organizations. Although the required procedures were in place already, the regulatory bodies raised concerns in failure to meet Good Documentation Practices and it’s requirements because of serious observations. Another reason was the lack of training and conveniently deviating complex procedures.
Later on, the instances of audit findings raised because of short audit frequencies and regular follow-ups on corrective actions. Awareness of data integrity then increased because of these instances, and industries started training their employees regularly with evaluation. Then, respective managements formed internal investigation teams for inspection of wrong practices with regular reporting of the observations to the authorities.
Knowing the impact because of the failure of these practices, they started strong majors and training guides for improving Good Documentation Practices in their organization. These procedures aim to establish the requirements for Good Documentation Practices, including elements of data integrity for maintaining quality records.
What is a GxP Document?
GxP Document: Document identified as critical in maintaining compliance with current GxP regulations i.e. For instance Good…
- Manufacturing Practice (GMP)
- Laboratory Practice (GLP)
- Documentation Practice (GDP)
- Clinical Practice (GCP) etc.
Apart from the above-mentioned practices, it is mandatory to maintain quality records in the long run for proper inspection and investigation. Good Documentation Practice involves a generally practiced set of characteristics described further.
ALCOA and ALCOA (+)
Most professionals working in the drug or medical device industry today are aware of ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principles of Good Documentation Practices for data integrity. Nowadays, some industries are improving this ALCOA to ALCOA+. Let’s understand each term of ALCOA and ALCOA plus (+). They are considered as the heart of Good Documentation Practices because of the respective importance they posses.
Following are the characteristics for Quality records considering Good Documentation Practices in place.
Capable to determine the origin and history. The document is also capable to refer to the individual responsible for the creation, maintenance, or handling the record. In critical times, this results in trace-ability. Therefore, sometimes Attributable considered as Traceable.
Capable of reading by the reader. The document is easy to read and is meaningful. i.e. Readable and Relateable.
Contemporaneous means Parallel, Simultaneous, or Concurrent. The document recorded simultaneously to the performed activity, considered as a contemporaneous entry. Data shall be recorded when the activity completes (include time and date stamps for electronic records).
Any form of quality record such as electronic, paper, magnetic, or optical. The original term refers to the availability or presence of data in its crude form, whether it is in paper or any other form i.e. the document in its original form. However, prints generated on some papers may fade away over time. For this case, prints shall be immediately photocopied to ensure the data is not lost in the future.
Consistent, factual, error free and recorded as it is.
Additionally, as an improvement over this, new characteristics were identified which are critical to data integrity apart from regular Good Documentation Practices core characteristics. This retained the improved ALCOA now known as ALCOA (+) which may have the following characteristics.ALCOA+ Characteristics
Data with all required information and providing a complete description of documented events. This means without a gap, following the description, the events can be reconstructed or repeated.
Consistent with the sequence of the events either ascending or descending
Free from variations in documentation style. Show the continuity in data flow.
All Quality Records must follow the appropriate record requirements for handling, storage, and disposition whether a record is paper or electronic.
Common Guidelines for Good Documentation Practices
Above seen are core characteristics of Good Documentation Practices. Now let’s go through other common guidelines or rules for that matter.
- Recording the entries before performing the activity or at a later time or backdated strictly prohibited. Write it as you do it and Do it as written. This ensures strict adherence to the established procedures.
- The recorded activity must have sign and date of the individual who performed it.
- Legible or readable data up to the life of the document. For handwritten entries: Enter all information in non-erasable, permanent, non-water-soluble ink as per applicable ink. Additionally, the use of pencil prohibited.
- Short-hand notes or vague statements not allowed.
- Use Controlled logbooks bounded and with numbered pages, track-able to allow for reconciliation.
- Take a photocopy for the data printed on thermal paper with original affixed with sign and date.
- Transcribe information in case of torn or damaged original paper with proper identification, issuance and keep original copy.
- Address all abbreviations in the record.
- Do not leave blank spaces in the record and fill in the blanks as “Not Applicable” or simply “N/A” with a single cross line diagonally, sign and date.
Example of Striking Not Applicable
- Provide an explanation for intentionally left blank spaces if filled later.
- Use consistent Date and Time format throughout the document or record. Date format in all numbers is acceptable, provided the same is captured in the document itself. Date format may depend region-wise. For example,
Europe: dd/mm/yy or dd/mm/yyyy
US: mm/dd/yy or mm/dd/yyyy etc.
- Time format may include 12-hour format or 24-hour format. If the time is recorded using the 12-hour format, then time must include the identifiers AM or PM (example: 8:00 AM, 9:00 PM). Any format of AM or PM (e.g. AM, a.m.) is acceptable as long as its meaning is clear in context. In the 24-hour format, 00:00 is midnight and the remaining hours are in sequence from 1 to 23 (e.g. 22:30 hr, 08:20 hr, etc.).
Round off values
- No round off allowed for observed values (such as individual temperature probe reading) recorded.
- Round off not performed till we calculate last value.
- If the first figure is greater than or equal to five (5), increase by 1; the digit in the last place maintained. Example: 145.366 = 145.37 or 145.365 = 145.37
- If the first figure is less than five (5), it maintains the previous digit. Example: 145.364 = 145.36
- Never erase original entries.
- Apply only single strike on the entry error to keep it legible and then make corrections.
- Cross entire entry through, even though only a portion is incorrect with sign and date. (e.g. cross out the entire number or word, not just one number or letter).
- Re-approval required if corrections made to the previously approved document. Ensure the same function(s) carries out Re-approval activity.
- Only doer or his/her supervisor to correct the data with explanation, sign and date. Where space constraint is the issue, the correction clearly linked to the corresponding reason at the bottom of the page.
- If multiple corrections on the same page, use sequential numbering method for proper identification with each sign and date individually.
- Do not use correction fluid (whitener), tape, blade or any other method which shows intentional data hiding.
Any act of hiding data may in form of fabrication, intentional misplace, falsification, alteration, or erasing known as Data Tampering. Willful false report or misleading the data not allowed including (but not limited to)
- Backdated entries
- Deliberate omission or manipulation of data which hides the event
- Sharing Account credentials across team members
- Entries for the activities performed by another associate
- Intentionally keeping correction fluids in plant or rough paper works etc.
- False signatures
- Fabrication of records (creating reports for which activities yet not performed)
- Any supporting data is attached to the record must be labeled with proper identification and label.
- Enlist attached appendices documented in the main report/record as applicable.
- Use page number formatting as “A of n”, where A=page number while n=total number of pages. For referencing annotations from regular bodies, page numbers are unnecessary.
- A best practice is to apply the header (the title of the document) and footer (page numbers) to a PDF file if attached as Appendix. Wherever possible, keep attachments in a non-editable format such as PDF along with watermarks.
GxP documents require a Signature with a date for identification and traceability in the future course of the review. Further, the significance of each signature according to Good Documentation Practices is mentioned below:
- Qualified Personnel: Any personnel signing any document or record is trained on that particular activity or entitled as Qualified for authorizing or certifying the document or record. Signature in the quality document indicates the accountability for what is contained in the document.
- Performed By: A personnel executing an instruction, operation, or calculation. Sometimes, the performer is also termed as “Doer” in which case “Performed By” turns into “Done By”.
- Verified By: A personnel verifying the activity performed by other personnel. Verification includes making sure or demonstrating the activity performed is true, accurate, or justified.
- Reviewed By: Conformity of completion, compliance to action/s with applicable specifications or requirements.
- Approved By: Conformity to complete review for action/s as per the requirement with all necessary signatures captured and issues addressed through GxP procedures if any.
- As per the above philosophy, it does not imply that the performer is not accountable for verification, review, and approval. Additionally, it means the performer has also read, understood, verified, reviewed to the best of his/her knowledge, and then signed.
- Ensure use of electronic signatures as per requirements (generally Computer System Validation CSV procedure).
- Wherever required, a quality review must include raw data, useful metadata, and audit trails.
Missing Data Management
During review or any point of time, if anyone notices that the data from record seems missing, it can be added if:
- Conformity to the existence of additional data verified
- Responsible function or immediate supervisor provides the required data
- Trace-ability of who added the data
- Additional data kept in record with old data
Record Retention Policy (Storage, Archival and Retrieval)
Besides the above policies, there must be a policy for record management including record retention period, archival methods, and retrieval requirements. This ensures that the industries follow Good Documentation Practices till the termination of the record. Recorded data in the form of either hard copy or electronic data must follow the requirements as per applicable local procedures company-wise.
These were the commonly practiced procedures for Good Documentation Practices to ensure the records are audit ready and traceable. The Good Documentation Practices not only apply to day to day commercial manufacturing but also to process validation and other tools employed in the healthcare industries. In short, it applies to manufacturing i.e. all the activities in healthcare industries from truck-to-truck and gate-to-gate.
Following are the definitions of the terms used in Good Documentation Practices for better understanding. You may want to go through for your knowledge enhancement.
- Audit Trail: Sequential record of computer or controller system activities that enable reconstruction or examination of events or series of events from start to end.
- Controlled Document: GxP document under defined procedures and governed by life-cycle management, including distribution within the organization.
- Data: Suitable representation of facts or instructions for communication or processing information by humans or systems.
- Data Integrity: ALCOA+ provides data integrity i.e. genuineness of the data.
- GxP: Critical documentation necessary to maintain compliance with current GxP regulations such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), or Good Laboratory Practices (GLP), etc.
- Meta-Data: Data capable of attributing personnel or meaningful information. Examples include Creation Date, Modification Date, Visual References, or something meaningful.
- Raw Data: Data kept in its originally generated format
- Traceable Data: Able to determine history or origin and tracked to individual responsible for monitoring or recording.
- Good Documentation Practices: Document handling, storage, archival, retrieval, retention, and disposal followed considering trace-ability, ALCOA+ principles, and without hampering data integrity.
If you want to have a quick summary related to Good Documentation Practices, you can check it here.
Good Documentation Practices: FAQs
What is the purpose of good documentation practices?
When Auditors challenge the integrity of any activity performed in a healthcare facility, raw data and records assure ready reference and traceability. In any healthcare facility, an activity that does not have a documented record suggests that activity as not-performed i.e. question mark on product quality. Hence the good documentation practices are a set of guidelines that help in assuring product quality.
What is good documentation practices in pharmaceutical industry?
Guidelines stating procedures for documenting any activity either on paper or electronically within the manufacturing premices, Truck to Truck and Gate to Gate. These guidelines describe the critical aspects of any document such as Attributable, Legible, Cotemporaneous, Original and Accurate.