Good documentation practices (GDocP or GRK) are crucial for complying with GMP regulations.
These records also aid in CAPA investigations and record-keeping for handling deviations and non-conformances, as well as recalls.
Recordkeeping Practices and Regulatory Audits (GDocP)
- Your record-keeping practices, documentation procedures and computer systems will be thoroughly scrutinised during TGA inspections, FDA audits or other regulatory inspections.
- This includes computer system validation activities, documentation practices and data governance (Data Integrity) — not only at your cultivation and/or pharmaceutical manufacturing facility — but at your supplier sites, warehouse storage facilities, and distribution channels.
Good Record-Keeping Practice (GRK) is imperative for passing numerous industry-specific quality inspections (PICS/GMP inspections and TGA or FDA GMP compliance audits). Including inspections of your compliance with ISO9001 Quality Management Standards, or other regulatory standards covering laboratories, medical devices and pharmaceutical manufacturing operations.
You can complete the Good Record-keeping Practice (GRK) training online (good documentation practice) by clicking here.
If your record-keeping practices and procedures are not up to current GMP and GDocP standards, you’re facing trouble. But how have new digital record-keeping technologies impacted pharmaceutical and medical device manufacturing businesses in terms of their good documentation practices and data integrity risks?
Read on to learn more about Good Documentation Practices (GDocP), with key points excerpted from resources listed on the TGA’s website, the FDA’s website, and PharmOut’s white paper on Good Documentation Practices (download the GDocP implementation white paper in PDF format).
Good documentation practices (GDocP) in modern times: Basic Record-Keeping in GMP Manufacturing
Good documentation practices are an essential part of cGMP and EU GMP compliance. But these have changed with new methods of record-keeping and data security technologies, including blockchain.
- If you’re working in a regulated industry, you know the importance of maintaining good documentation standards
- But you might not realise how record-keeping has changed over time, and what new methods of data-entry/data recording means to your QMS (quality management system) in terms of potential data integrity/data security risks
- And for Pharma 4.0, get ready for blockchain (watch a video from IBM about blockchain and SAP for cold chain supply/distribution record-keeping)
How have good documentation practices — including signature registers and other requirements — changed with disruptive digital technologies, including blockchain?
Digital technologies are forever expanding; with automation and real-time recording built-in to many production and distribution systems. But new technologies can both help — and hinder — your compliance with GMP (PIC/S).
Organisations must consider the risks of new data recording systems. QMS managers must ensure they include record-keeping risk assessments and documentation validation processes in frequent self-inspections, quality management reporting and continuous improvement initiatives.
- New technologies brought many documentation benefits to manufacturing industries
- But new technologies also enabled unprecedented documentation risks
- So like all technological changes, these systems need to be carefully risk-assessed and managed, including after data system updates or upgrades; as with any new technology having the potential to impact your production and distribution systems or your data integrity/security.
The impact of digital technology on good documentation practices (GDocP)
Digital technologies enabled new methods for data validation and record-keeping security; e.g., automated date-stamping and documentation change-tracking systems.
GMP Investigations: regular self-inspection of documentation practices is a must, as it’s a frequent area for failure(s) during FDA and TGA audits of your GMP and GDocP.
But not every organisation is aware of the full extent of risks that new record-keeping technology can bring to a GMP organisation. Nor does every organisation adequately train (and re-train) their employees in good documentation practices.
It’s no surprise, then, that inadequate documentation practices are an area of frequent GMP (PIC/S) audit failures, when the FDA, TGA or other regulatory agency come to inspect your premises and documentation practices at every stage of production and distribution.
Data Integrity Risks | Pharma 4.0
- Some new technologies enable tamper-proof, real-time documentation practices; yet new technologies can also add new risks to your data integrity and quality management systems (QMS).
- New risks stem from the latest digital data collection methods, for example:
- photoshopping documents
- copying digital signatures
- sharing log-ins
- new employees and/or contractors not getting timely log-ins
- neglecting to immediately add new signatures and initials (or suppliers and contractors) to the signature register
- neglecting to train employees, warehouse and transportation/delivery workers and suppliers in GDocP, even though you’re responsible for ensuring their compliance as the responsible person/entity
The net result of technological advances in record keeping and data storage — is that new digital systems have the capacity to either help — or hinder — authentic record keeping and data integrity assurances.
Many new data systems are designed to reduce data integrity risks and data security risks.
But these systems must be thoroughly validated and risk-assessed. QMS must assess all processes, systems and storage methods to evaluate new digital technologies, including automated record keeping, for documentation weaknesses and/or data security concerns or system failures.
Continuous improvement initiatives for record-keeping systems and data storage methods are a must in modern times; as are frequent risk assessments and employee training/refresher courses in good documentation practices (GDocP).
Solution: To reduce record-keeping failure risks, documentation procedures, data-entry systems and employee training in record-keeping all need to be continually risks-assessed, and re-validated, as part of your QMS self-inspection processes.
So what do Good Documentation Practices (GDocP, formerly called GDP) actually require for employees and contractors working in the pharmaceutical, veterinary medicines, laboratory testing or medical device manufacturing industries?
As the saying goes, “if you didn’t write it down, it didn’t happen.” If your record-keeping fails to meet standards for GDocP (PIC/S), the result is the same — a GMP audit failure, unacceptable product safety risk and liability — which could lead to jail time for managers and owners who fail to implement proper record-keeping and data security measures.
Good documentation practices (known as GDocP vs GDP, which stands for good distribution practices), are an imperative part of assessing risks and managing production quality to GMP / EU GMP, PIC/S and other industry standards. They are imperative for batch tracing, quality management and recall procedures.
But new digital record keeping methods, if not engineered to current data integrity standards, can lead to data integrity risks, security and safety risks, and GMP audit failures.
Log-in details and signature registers, passwords, system use tracking, and other data security/data integrity risk management — including employee training — need to be regularly assessed, validated and risk-managed.
As breaches of data security occur frequently throughout the world, you’ll want to ensure your data systems and record-keeping procedures are risk-assessed, tamper-proof, secure, validated and investigated on a regular basis as part of your quality management system (QMS).
For GMP consultancy or GMP audit assistance or quality management systems (QMS) and data integrity consultancy, visit PharmOut’s site. You can also browse our top online GMP training courses for industry-specific training.
Who enforces Good Documentation Practices (GDocP)?
Remember, GDocP was formerly called GDP, but GDP is now exclusively used for Good Distribution Practices.
- Your organisation’s Quality Manager (typically working within the Quality Risk Management Department or in Quality Assurance) will aim to ensure employees, contractors and vendors follow GDocP and GDP, as well as other components of GMP.
- GDP and GDocP can also be an inspection area (audit area/audit response) when government agencies inspect your people and premises.
- These government agencies could include the TGA or FDA, although they may focus on other areas of GMP during their GMP audits.
Names and roles of these regulatory agencies will vary, depending on where you are located and/or where you are importing or exporting your pharmaceutical goods, source supplies, medical devices, veterinary medicines or other types of medicines (e.g., blood and tissue products).
Regulatory bodies enforcing GMP (Gxp) including Good Documentation Practices include:
- the USA’s FDA (Food and Drug Administration)
- Australia’s TGA (Therapeutic Goods Administration)
- EMA (UK)
- Health Canada (Canada)
- WHO (World Health Organisation)
Online E-Learning Courses that contain information on Good Documentation Practices and Data Integrity
Warehousing and Distribution Practices – a required GMP training topic for employees, contractors and suppliers working in the distribution of pharmaceuticals and other regulated products including goods with high illicit value (GHIV)
The 4-course training bundle Includes: Good Warehouse Practices (GWP), Good Record Keeping (GRK), Good Distribution Practices (GDocP) and 10 golden rules of GMP.
Or for individual or onsite training courses, review GMP training courses by PharmOut’s GMP Training, learning and development expert, Maria Mylonas and other GMP manufacturing and medicinal cannabis TGA industry experts.
For GMP consultancy and/or GMP audit assistance, validated quality management systems (QMS) and other data integrity or production engineering and distribution practice consultancy, visit PharmOut’s site.
You can also browse our top online GMP training courses for industry-specific training, available in bundles. Onsite custom courses by Maria Mylonas are also available at your facility anywhere in the world.
First published 19 July 2019.
Page last updated: April 15, 2021.