The concept of Good Documentation Practices (GDP) is used in every healthcare industry to demonstrate high-quality medicines or medical devices through genuine and up-to-date records.
These procedures include a high level of documentation activities to make sure they are traceable and audit-ready.
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. Trade loss and whatnot.
They’re permanent stigma to the well-established organizations.
Although the required procedures were already in place, the regulatory bodies raised concerns in failure to meet Good Documentation Practices and its 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 within the industries because of these instances, and they 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 programs for improving good documentation practices in their organization.
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, it is mandatory to maintain quality records in the long run for proper inspection and investigation. Good Documentation Practices involve 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.
Following characteristics helps to produce and maintain quality records within a framework of Good Documentation Practices.
Attributable means the document is capable to determine the origin and history of the performed activity.
The document is also capable to refer to the individual responsible for the creation, maintenance, or handling of the record. When investigating critical situations, this helps in traceability. Therefore, sometimes Attributable considered as Traceable.
Legible means the document is 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 (includes time and date stamps for electronic records).
Any form of quality record such as electronic, paper, magnetic, or optical is considered as Original.
The original term refers to the availability or presence of data in its crude form, whether it is in paper or any other but in 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.
Document that is consistent, factual, and recorded at actual is considered as Accurate.
As an improvement over ALCOA, new characteristics critical to data integrity were identified by the experts. This emerged out as improved ALCOA termed as ALCOA+ consisting following characteristics.
Data with necessary information providing a complete description of documented events without any gaps such that following that description, the events can be reconstructed or repeated.
Data with all required information and providing a complete description of documented events without gaps such that following that description, the events can be reconstructed or repeated.
Document that contains information consistent with the sequence of the events.
Data must not merely exist, it must be accessible all the time.
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
Now we’ve seen the core characteristics of the GDPs, let us move on to other common guidelines.
- 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 the 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 a pencil is prohibited.
- Short-hand notes or vague statements not allowed.
- Use Controlled logbooks bounded and with numbered pages, trackable 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 the 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 a single strike on the entry error to keep it legible and then make corrections.
- Cross the 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 the 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 the form of fabrication, intentional misplace, falsification, alteration, or deletion is known as Data Tampering. Willful false report or misleading the data is not allowed at-least including:
- Backdated entries
- Deliberate omission or manipulation of data that 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 a review or any point of time, if anyone notices that the data from the record seems missing, it can be added if:
- Conformity to the existence of additional data is verifiable
- Responsible function or immediate supervisor provides the required data
- Traceability of who added the data is available
- Additional data is kept in the records with the old data
Record Retention Policy (Storage, Archival and Retrieval)
Apart from the above things, 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.
In short, it applies to manufacturing i.e. all the activities in healthcare industries from truck-to-truck and gate-to-gate.
You may want to go through some of the common definitions useful for understanding GDP procedures.
- 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 is 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 premice, Truck to Truck and Gate to Gate. These guidelines describe the critical aspects of any document such as Attributable, Legible, Cotemporaneous, Original, Accurate, Complete, Chronological, Available, and Permanent.