Documentation is one of the most valuable assets in the regulated healthcare industry. Information generated during the many years of healthcare product development must be properly documented so that correct, complete and consistent information can be provided to your regulatory agency in support of regulatory submissions and inspections.
As different individuals have their own ideas or methods for documenting information, simply tracking everything does not equate to implementing Good Documentation Practices (GDP). Without standardized documentation rules (for example, the requirement of document review and approval), documents generated may contain various different formats and content from which it is difficult to generate an integrated analysis and present it in a regulatory submission. Inconsistency across documents can also lead to an inadequate level of data being recorded, inaccurate data being collected, or incorrect interpretations being produced. GDP is therefore an expected practice in the regulated healthcare industry.1-3
Use of Good Documentation Practices is expected in healthcare product development
The use of GDP allows companies to comply with regulatory requirements such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) or the applicable quality management system (for example, ISO 13485, 21 CFR 820), or Good Clinical Practices (GCP) in Canada, the US and the EU. Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to GDP.
In addition to this regulatory expectation, it is essential to keep in mind that any and all records generated may be used by any member of the sponsoring company (that is, the applicant) or their business partners, contract research organizations (CROs) and contract manufacturing organizations (CMOs) in support of development, testing and manufacturing, as well as the conduct of laboratory, animal and clinical studies. End-users can also include potential investors, lawyers, patent reviewers, regulators (reviewers and inspectors), or the general public. Thus it is critical for sponsors to standardize their documentation activities (that is, GDP) so that records will be consistent and clear.1-3
Documentation that should follow GDP includes but is not limited to:
- Laboratory notebooks
- Master batch records
- Product release certificates
- Analytical methods
- Protocols and reports (for example, validation, sterilization, stability, laboratory, animal and clinical studies)
- Purchase orders
- Training records
- Medical-device history files and records
Key qualities of regulated documents
What key qualities are needed in your records? Generate documents that are:
- Concise: Present information clearly so it can be easily understood with no room for misinterpretation. For example, the date format “05/06/12” can cause confusion. Use one that is unambiguous, such as “05 Jun 2012.”
- Legible: Information should be readable and leave no room for error (for example, hand-written data that are not legible may cloud data analysis or result in “missing data”).
- Accurate: Documentation should be error-free―properly reviewed, verified and approved. Information should be recorded as an event happens and not after the fact, so as to avoid recording “what you remember” rather than “what actually happened.”
- Traceable: Documentation should be traceable. Make it clear who logged the information, what it was, and when and why it was documented.1
Do’s and don’ts
Depending on the needs of your organization, GDP can include many different activities. Evaluate what applies for you. Some basic GDP “do’s and don’ts” are listed below. 1,2
- Use black or blue permanent, indelible ink.
- Make clear, complete and legible entries.
- Make an entry when an event happens (not later).
- Make corrections that are legible and traceable. For example, when a correction is required, put a line through the error, make the correction next to the error, include an explanation (if it is not self-explanatory), and initial and date the correction.
- If it is not appropriate to fill in a space in a document (such as an empty page), enter “N/A,” your initials and the date so that no further information can be added later.
- Follow established standard operating procedures (SOPs)―for example, document review and approval processes, version control, and date and time formats, as well as record retention, change control, electronic signature (if applicable) and so on.
- Provide training to everyone in company.
- Do not use pencils or erasable ink.
- Do not use “write-out” or any masking devices.
- Do not make corrections that are not traceable (for example, overwriting entries with no date, initial or explanation).
- Do not use “sticky” notes.
- Do not back-date or post-date.
- Do not use ditto marks.
- Do not use asterisks that may cause confusion (such as using the same asterisk for different footnotes).
- Do not transcribe data.
- Do not use unbound laboratory notebooks without page numbers (that is, avoid any doubt concerning missing pages).
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012
- Sachdeva, V. (n.d.). Good documentation and quality management principles. Retrieved May 30, 2012, from http://apps.who.int/prequal/trainingresources/pq_pres/stakeholders_2011/presentations/Day_2/Good_Documentation_Practices.pdf.
- Berga, J. (2009, August). Good documentation practices (GDP): What should my GDP standards be? Retrieved May 30, 2012, from http://www.slideshare.net/John_Berga/good-documentation-practices-presentation. [Slides].
- Richardson, M. (2010, October 18). Good Documentation Practices (GDP) are Critical to Success! Retrieved September 26, 2012, from http://www.askaboutvalidation.com/good-documentation-practices-gdp-are-critical-to-success/.