GMP Basics of Good Documentation Practices (GDocP)
Good documentation practices (GDocP) are key components of GMP compliance. Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation practices — and your products — meet industry standards and legal requirements for safety, efficacy and product quality.
Good Documentation Practice (GDocP — or GRK for Good Record Keeping) is an essential component of your overall quality management systems (QMS) and risk management strategies (QRM).
It’s good business practice no matter what you service, produce or sell in your organisation.
Record-keeping SOPs help manufacturing operations meet their PIC/S GMP requirements (quality standards and risk management standards). They are particularly crucial in pharmaceutical, veterinary medicine and medical device manufacturing industries, given the risk to end-users of the products (e.g. consumers/patients, pets and livestock).
Good documentation practices are also essential for attaining ISO-9001-2015 certification and other industry-specific ISO certifications specific to your industry, e.g. ISO/IEC 17025 (for laboratory testing and calibration standards); ISO/IEC 27001 (for information security management system / ISMS) and ISO 13485:2016 (for medical device manufacturing).
FDA or TGA Audit Failures | Documentation Practices
You can nearly guarantee your documentation procedures and data integrity / record-keeping systems validation reports will be targeted in your next GMP / EU GMP audit or other quality management system inspections.
Inadequate compliance with good documentation practices (GDocP) is a frequent FDA and TGA audit failure finding.
Your entire organisation must stay up to date with good documentation practices training requirements and QMS/compliance monitoring; including employees, contractors, vendors and distribution-chain personnel (warehouse workers, transport drivers and others involved in production, packaging, storage, transportation and delivery).
Inadequate documentation practices and record-keeping weaknesses are key targets for FDA inspections, TGA inspections and QMS audits.
Before we discuss the basics of good documentation practices for beginners, good documentation practices (GDocP) should not be confused with good distribution practices (GDP).
- Documentation practices should always be referred to as GDocP (not GDP), although many publications haven’t stopped using the acronym GDP for both documentation and distribution practices.
- Double meanings for the acronym GDP will increase your quality management system issues; so be sure you specific GDocP for good documentation practices.
For Beginners | GMP Basics for Good Documentation Practices
All GMP and ISO standards depend upon good documentation practices, including data integrity and data system validation, data system monitoring and continuous improvement initiatives.
Aim and purpose of good documentation practices (GDocP) in pharmaceutical and medical device manufacturing
Good documentation practices (GDocP) aim to ensure globally-accepted standards are met in record-keeping and reporting. GMP, PIC/S and ISO9001-2015 documentation standards relate to:
- data accuracy
- recorded accurately
- cross-checked for errors
- not intentionally misleading (prevents fraudulent entries, editable entries)
- data integrity/validation
- genuine, true data
- validated and supported/witnessed; vs intentionally falsified
- relevant to the reporting requirement
- not changeable after original record-keeping entry (extensively tracked changes)
- reporting/record-keeping timeliness
- information is recorded contemporaneously
- real-time record keeping including date stamps (e.g., automated time-stamping)
- prevents errors from memory-issues and prevents editing of original data
- legible (readable by anyone, removing guesswork)
- readily accessible
- clear records that can identify the person who actually records the data
- Blockchain is increasingly being discussed as part of Pharma 4.0 innovations
- watch for other new technology adaptations for GDocP as systems evolve
- Especially given growing global concerns about counterfeit pharmaceuticals and cosmetic medicines and substandard medicines and fake antibiotics entering global pharmaceutical chains
- GMP and GDocP requires no shared passwords (and high-tech digital security for data integrity purposes and data entry tracking/logging identification)
- clear records that can identify the person who actually records the data
More information on GMP basics of Good Documentation Practices (also called GDocP).
GDocP goes beyond being an organisation-wide requirement. It also applies to contractors, vendors/suppliers, and any other individuals or companies involved in your production and supply chains. In fact, documentation AND distribution practices are areas where a number of companies end up breaching GMP and PIC/S standards for documentation practices.
As the manufacturer (product sponsor), you’re organisation is ultimately responsible for ensuring EVERY person involved in the production and distribution of your products has attained appropriate GDocP compliance training (with proof, e.g. assessments/training certificates).
GDocP Investigations, Self-Inspection Findings and GMP Audits
- To avert breaches of standards regulations (e.g., ISO9001, TGA and FDA audit failures), GDocP compliance investigations need to be performed regularly
- This includes training, monitoring and assessing the documentation practices and systems used by contractors, suppliers, transportation personnel and other vendors and service providers
Self-Inspections for GDocP (GxP) compliance are recommended to be performed more frequently than your annual self-inspection requirement.
- Many manufacturing businesses perform self-inspections more frequently than their annual requirement, in order to improve compliance, reduce risks and initiate continuous improvements and CAPAs as part of their quality management system (QMS)
- Internal investigations in relation to GDocP helps reduce risks related to product safety, such as interception or tampering, and are crucial pieces of evidence and batch traceability, especially during a potential product recall
GDocP compliance investigations can help reduce your risks of failing a TGA or FDA GMP audit.
Just remember to include everyone in your distribution supply chain, including contractors, service providers, drivers and warehouse personnel.
- All people who have contact with your product, at any stage of production or delivery, need to have evidence of GDocP training and regular compliance assessments
- The FDA and TGA will likely investigate your employee and service provider training certificates and documentation practices — including contractors — and they’ll do so in-depth!
- That’s because good documentation practices are part of the 10 golden rules of GMP
Your GDocP and GxP training responsibilities include everyone in your production and transportation chains when you distribute (ship and deliver) your products to various warehouses, chemists/pharmacies or other clients.
Good documentation practices (requirements) apply for any delivery region or country; although some countries have different GDocP requirements — DO check before you ship.
Documentation Types | Good Documentation Practices
What types of documents or record-keeping is required in the pharmaceutical industry or in the production of medicinal cannabis, medical devices, blood and tissue products and veterinary medicine production?
Examples of records for which employees/contractors and suppliers must adhere to good documentation practices (GDocP as part of GMP including GDP or distribution) include, but are not limited to:
- Analytical Methods
- Annual Self-Inspection (Procedures, Implementation and Findings/Actions)
- Batch Records / Supply Sources
- Bills of Materials (BOMs)
- CAPA (Corrective Actions and Preventative Actions)
- Clinical Study Records
- Cold Chain reports and climate testing measurements/records
- Complaints and complaint handling/monitoring
- Continuous Improvements
- Certificate of Analyses (CoA)
- Certificate of Compliance (CoC)
- Distribution records including Routes, Storage and Delivery Records
- Incident Reports
- Laboratory Notebooks / Logbooks
- Labels (Product Labels and sampling labels)
- Policies (documentation including approvals and distribution/employee training records)
- Protocols and changes to protocols (change management system documentation including approvals)
- Quality management records / QMS systems
- Recalls and Recall Policies
- Releases (QMS approvals by trained, competent and authorised personnel)
- SAE reporting (serious adverse events reporting)
- Source suppliers and source supply testing/monitoring
- Standard Operating Procedures
- Test Methods / Quality Testing methods including validation and record keeping
- Training | GMP training for Employees, Contractors, Suppliers/Vendors including your distribution/warehouse and transportation personnel or contractor(s)
- Work Instructions (Workflow, procedures, SOPs)
- Workplace Safety reports/record keeping
- Validation (methods, reports and related documentation including IQs, OQs and PQs)
Documents and records can fall into various classification systems, and in general, there are 4 key classifications for documentation.
- Primary Records (examples: production formulas, supply source documents, contracts, packaging instructions)
- Procedures or supporting procedures (instructions and guidebooks, SOPs)
- Subsidiary records (help meet GMP, e.g. calibration readings reports, print outs, other supporting documents)
- Quality Control records (testing results, testing methods, recall procedures, investigations, self-inspection reports, CAPA, more)
GDocP | What are the specific requirements for good documentation practices in pharmaceutical production including medicinal cannabis and other herbal medicines, veterinary medicines and medical device manufacturing?
Check your organisations SOPs (Standard Operating Procedures) and work instructions for details.
You must also attend training and refresher training for good documentation practices.
Basic requirements for good documentation practices will include, but not be limited to, the following components:
- Data Integrity (protected, secure and backed-up data systems)
- Contemporaneous record-keeping (timely, immediately/real-time)
- Readily identifiable as to who recorded it (no shared passwords or shared data system log-ins, no forging of signatures even if requested)
- Readily accessible when required
- Signature record log and register
- initials and signatures of all employees, contractors and suppliers who fill in documentation
- a secure database to match initials and signatures with the actual identity of the person who recorded the data
- Security / Data Integrity
- Data must not be able to be altered or erased once entered or recorded
- No white-out is permitted in GMP facilities and no gel pens (specific writing instruments are designated in your SOPs and working instructions)
- Specific rules must be followed when altering a record, such as a legible cross through of the data and the correction listed with your registered initials and the time/date (and reason for the change, depending on the record-keeping requirements)
For GMP consultancy or GMP audit assistance, including quality management systems and data integrity consultancy, contact PharmOut’s leading consultants (international expertise in GMP industries and PICS compliance including QMS and audit failure recovery.
References, Sources and Further Reading
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.
Page last updated: August 1, 2019.