Good Documentation Practice
Good documentation practice (GDocP), also known as good record-keeping practice or GRK, is a set of internationally accepted guidelines that ensure the reliability, integrity, and veracity of data collected during the research, development, manufacturing, and testing of drugs and medical devices. In essence, good documentation practice is the systematic procedure of preparation, reviewing, approving, issuing, recording, storing, and archiving documents—all with the ultimate goal of delivering drugs and medical devices that are safe and effective.
|What is documentation in the context of GDocP?|
Documentation includes worksheets, notebooks, records, memorandum, notes, maps, photographs, or electronic files that are the result of original observations and activities related to the development and production of drugs and medical devices.
Good documentation practice guidelines are considered to be the minimum requirements to ensure that data is accurate and will not be misconstrued or misused throughout all the aspects of a product’s lifecycle. In addition, good documentation practice is designed to confirm that the documented work can be reconstructed by following the documentation.
Good Documentation Practice Standards
The standard requirements for the quality system used in GDocP are set by the International Organization for Standardization (ISO). It requires that documentation must be created and retained to provide a traceable, historical record of all activities as well as be readily accessible for product investigations, periodic product reviews, or any internal or external (e.g., FDA, EMA) audits.
The following documents must comply with the data integrity requirements of good documentation practice, because they have the potential to impact product quality.
- Analytical methods
- Batch manufacturing record forms
- Bills of materials (BOMs)
- Calibration records
- Certificate of Analysis (CoA)
- Certificate of Compliance (CoC)
- Electronic and hardcopy Quality records (e.g., non-conformance, corrective and preventative actions, internal inspection, change control, training documents)
- Forms/log sheets
- Informed Consent (IC)
- Laboratory notebooks
- Product and sample labels
- Standard Operating Procedures (SOPs)
- Technology transfer reports
- Test methods
- Training documentation
- Training assessments
- Validation documentation
- DQs (design qualifications)
- IQs (installation qualifications)
- OQs (operational qualifications)
- PQs (performance qualifications)
- Work instructions (WIs)
A commonly used approach to achieve the necessary levels of data integrity is following the ALCOA principles. The FDA and EMA both use ALCOA to assure the integrity of their data and to meet good documentation practice requirements.
The ALCOA Principles
- All hand-written content, including signatures, in permanent ink
- Changes in data, including the date and reason for the change
- Date when the data was collected and recorded
- By person contributed the data
- Unique to the individual
- Listed in a signature register
- What signature signifies (e.g., recorded by, examined by, verified by, approved by)
- Adequate space provided in forms
- All content, including calculations and transformations, is understandable
- Clearly written so someone else can understand it
- Notes located appropriately on a page so readable (i.e., not scrunched in margins)
- Documentation records exactly what is observed or displayed
- No pre-filled items, such as dates, times, data, or initials
- Should a signature and date be required, the date is to be completed by the person signing the form
- Electronic capture system has been validated
- Location of the source noted and accuracy confirmed for documentation that came from a transcription
- Original data for initial entry
- Record in the appropriate location, such as forms or notebook on the first occasion
- Complete and free from errors
- Recorded exactly as observed or displayed
- Distinction between calculated vs. actual
- Estimates designated clear delineated
- Unforeseen or unusual observations/events recorded
- Contextual and explanatory information included
Good Documentation Practice Regulations
A number of groups have good documentation practice regulations and requirements for certification, including:
- FDA Code of Federal Regulations Title 21 (CRF 21) Part 211 Current Good Manufacturing Practices
- 21 CFR Part 58 Good Laboratory Practices
- 21 CFR Part 820 Quality System Regulation
- EudraLex Volume 4 Good Manufacturing Practices
- International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 Good Manufacturing Practices
- PIC/S PE 009-8 Guide to Good Manufacturing Practices for Medicinal Products
- ISO 9001-2015 for quality management systems
- ISO/IEC 17025 for laboratory testing and calibration standards
- ISO/IEC 27001 for information security management system
- ISO 14001 for environmental management
- ISO 13485:2016 for medical device manufacturing
GDocP and Good Manufacturing Process (GMP)
GDocP and GMP can be considered partners in the GxP ecosystem. GMP covers the manufacturing of drugs and medical devices. GDocP provides guidelines for all forms, notes, and other documents that must be produced and collected to meet GMP and other regulatory requirements.
Every stage of production and distribution must be documented. Failure to follow good documentation practices is a common point of failure in GMP and other audits. This inadequate documentation can not only slow time to market, but also result in costly operational remediation, legal action, and penalties.
Good Documentation Practice Compliance
Good documentation practices are required to comply with GMP regulations. Accurate and complete documentation ensures traceability of all development, manufacturing, and testing activities. Documentation also helps auditors assess the overall quality and efficacy of operations within a company and the final product.
|Good Documentation Supports the FDA’s CAPA Investigations|
This description of the FDA’s CAPA investigations is an example of good documentation practice’s important role.
The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem.
To maintain compliance, documents associated with a project should be part of the SOP. Quality assurance teams should maintain a list of documents that must comply with GMP along with associated SOP. In addition, processes should be in place to manage and regulate the issuance and retrieval of these documents.
Regulatory bodies that enforce good documentation practice as part of GMP and GxP include:
- Australia’s TGA (Therapeutic Goods Administration)
- European Medicines Agency (European Union)
- FDA (Food and Drug Administration)
- Health Canada
- WHO (World Health Organization)
Bonus Benefits of Good Documentation Practice
To meet the requirements of good documentation practice, processes and procedures must be put in place and monitored. Training users on the importance of good documentation practice and how to follow it is also essential. Following good documentation practices helps individual organizations and the industry establish consistent practices that reduce misinterpretations, minimize miscommunication, and improve product quality. And, as a bonus, good documentation practice helps protect intellectual property rights.
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Last Updated: 10th February, 2022