Good Documentation Practice (GDP): Quality Need

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Introduction and Outcome

Good Documentation Practices or GDP plays a vital role in pharmaceutical industries since documents is the supreme asset. It does not matter how much work has been done, from route of selection to development to manufacturing to shipping the pharmaceutical to the customer, if activities are not documented, it means work has not been done. It ensures quality, safety and efficacy of the pharmaceuticals. Good Documentation Practices (GDP) is also an important component of the GLP. That’s why I decided to share my expertise on this topic. In this article, you will learn GDP definition, key components, advantages, frequently asked question and case studies.

Good Documentation Practices: Definition

Good Documentation Practices or GDPs define best practices for creating and managing paper and electronic documents.

GDPs must be followed for all potential documents such as Analytical method validation, technology transfer, Standard operating procedure or SOP, Standard test procedure or STP, Monograph, Analytical control, raw data, procedures, deviations (OOT and OOS), investigation report, batch records, training records, calibrations, DMF, Deficiency letters etc,

Principles of Good Documentation Practices

The principle of GDPs relate accuracy, clarity, timeliness, traceability, consistency, legibility, autorisation, version control, protection retention, training, validation, review cycles, risk-based approach root cause analysis and continuous improvement.

10Cs of the Good Documentation Practices

10Cs of the documentation defines writing procedure. According to 10Cs simple writing is better. The following are the components of the 10Cs:

1. Clear: Simple and surgical explanation
2. Concise: No unnecessary word
3. Correct: No mistake in grammar
4. Coherent: Logical flow of content
5. Complete: Comprehensive information for leader
6. Creative: Use of expertise in explanation
7. Considerat: Easy to read, with bullet, headings, and subheadings.
8. Concrete: It should be specific and selective. Use of number, date, time, address etc.
9. Courteous and: Avoid commands, demands & you
10. Credible: Facts based explanations and not opinion based explanation

Regulatory Requirements: Good Documentation Practices

The pharmaceutical industry is governed by several regulatory bodies and guidelines, ensuring that high standards are maintained in documentation practices. The United States Food and Drug Administration (FDA), one of the most influential regulatory agencies, lays down stringent requirements and expectations for documentation in pharmaceutical industries. Compliance with Current Good Documentation Practices (cGDP) is not only essential but also a legal requirement for pharmaceutical companies.

4 Key Components of Good Documentation Practices

The following are the key components of the GDP:

1. Document hierarchy and organization
2. Document control and versioning
3. Data integrity and validation
4. Document review and approval processes

Document hierarchy and organization: Establishing a logical and coherent structure

The foundation of good documentation practices lies in the establishment of a well-structured and organized document hierarchy. This ensures that information is easily accessible, reduces redundancy, and promotes clarity and consistency across all documentation.

Document control and versioning: Ensuring accuracy, traceability, and accessibility

Accurate and up-to-date documentation is crucial in the pharmaceutical industry. Implementing robust document control and versioning mechanisms ensures that all authorized personnel have access to the correct and most recent versions of documents. This helps prevent errors, maintain traceability, and facilitates efficient collaboration.

Data integrity and validation: Maintaining data accuracy, completeness, and reliability

The integrity of data documented in the pharmaceutical industry is of utmost importance. By implementing stringent data integrity and validation measures, organizations can ensure that data is accurate, complete, and reliable. This minimizes the risk of errors, preserves the credibility of data, and promotes trust in the final products.

Document review and approval processes: Establishing robust quality assurance mechanisms

The review and approval processes for documentations play a pivotal role in maintaining high-quality standards and compliance. A well-defined and structured procedure ensures that documents are thoroughly reviewed for accuracy, completeness, and adherence to regulatory requirements. This helps mitigate risks, enhances quality assurance, and fosters a culture of continuous improvement.

5 Best Practices for Document Creation and Management

To optimize document creation and management processes, pharmaceutical industries should follow the following 5 best practices:

1. Defining clear objectives and purpose for each document
2. Standardizing document templates and formatting guidelines
3. Implementing efficient document creation, review, and approval workflows
4. Ensuring document security and confidentiality
5. Ensuring Accuracy and Completeness in Documentation

Defining clear objectives and purpose for each document

Before embarking on the creation of any document, it is essential to define clear objectives and understand the purpose it will serve. This ensures that the document fulfills its intended function and contributes effectively to the overall documentation system.

Standardizing document templates and formatting guidelines

Standardized document templates and formatting guidelines not only enhance consistency but also simplify the creation and comprehension of documents. By establishing a set structure, organizations can streamline their documentation processes and facilitate ease of use for employees.

Implementing efficient document creation, review, and approval workflows

Efficiency in document creation, review, and approval workflows is essential to ensure timely completion and accuracy. Implementing electronic systems or specialized software can help streamline these processes, automating certain tasks and improving overall efficiency.

Ensuring document security and confidentiality

The sensitive nature of documentation within the pharmaceutical industry necessitates robust security measures. Implementing restricted access controls, encryption techniques, and regular system audits helps protect documentation from unauthorized access, safeguarding critical information and ensuring confidentiality.

Ensuring Accuracy and Completeness in Documentation

In the pharmaceutical industry, accuracy and completeness in documentation are paramount. By establishing rigorous quality control mechanisms, organizations can minimize the risk of errors and omissions. Some important considerations include:

• Ensuring that documented information matches the actual observations and outcomes
• Validating data through appropriate means, such as statistical analysis or independent verification
• Conducting regular audits and checks to identify and rectify any documentation errors promptly
• Promoting a culture of responsibility and accountability among employees when it comes to documentation accuracy and completeness

Different departments and their Good Documentation Practices

Good Documentation Practices in the Manufacturing department

To maintain product quality and compliance, it is imperative to document manufacturing processes and procedures comprehensively. Key aspects to consider are:

• Creating detailed manufacturing instructions and procedures that outline step-by-step processes, equipment requirements, and environmental conditions
• Documenting equipment calibration and maintenance activities to ensure accuracy and reliability of manufacturing outcomes
• Capturing environmental conditions and monitoring data during the manufacturing process, providing crucial contextual information for quality assurance and troubleshooting when needed

Good Documentation Practices in Quality Control (QC) and Quality Assurance (QA)

In the pharmaceutical industry, quality control and quality assurance play a crucial role in ensuring product efficacy and safety. Documentation becomes indispensable in these areas:

• Creating comprehensive testing and analysis protocols that include sample collection methods, equipment specifications, and acceptance criteria
• Documenting test results, deviations, and any corrective actions taken to address non-compliance with quality standards
• Maintaining records for equipment qualification and validation, ensuring that all testing equipment meets regulatory requirements and produces accurate results

Good Documentation Practices in Analytical Research and Chemical Research department

Analytical Research and Development(ARD) and Chemical Research and Development (CRD) departments generate invaluable scientific insights and inventions that drive innovation in the pharmaceutical industry. Proper documentation practices are essential in this critical domain.

• Documenting experimental protocols and procedures in ARD and R&D projects, capturing detailed methodologies and observations
• Accurately noting down research findings, observations, and conclusions, aiding in the development of hypotheses and the formulation of strategic decisions
• Documenting intellectual property and patent-related information to protect valuable discoveries and inventions from unauthorized use

Training and Compliance and Good Documentation Practices

To ensure proper implementation of good documentation practices, training employees is imperative. Key considerations include:

• Highlighting the importance of good documentation practices, emphasizing its impact on product safety, regulatory compliance, and business success
• Conducting regular training sessions to ensure employees understand the specific requirements and guidelines for documentation in various departments
• Establishing a system for documenting and monitoring employee training progress, enabling easy identification of areas in need of improvement or additional training

Documenting Changes and Deviations: Good Documentation Practices

In a dynamic industry like pharmaceuticals, changes and deviations from standard procedures are inevitable. Proper documentation is crucial to ensure documentation accuracy, transparency, and effective communication:

• Documenting change controls to record any alterations made to processes, procedures, or specifications
• Reporting and documenting unexpected incidents and adverse events promptly, enabling investigations and remedial actions
• Effectively communicating changes and deviations to relevant stakeholders through clear and concise documentation, minimizing confusion and ensuring compliance with regulatory requirements

Role of Good Documentation Practices Audits and Inspections

The pharmaceutical industry is subject to regular audits and inspections by regulatory bodies. Effective documentation practices enable organizations to optimize their compliance efforts and achieve successful outcomes:

• Preparing for regulatory audits and inspections by ensuring meticulous documentation throughout the entire documentation lifecycle
• Organizing documents in a logical and easily retrievable manner to facilitate prompt retrieval and presentation of required documents during audits
• Addressing observations raised during audits and implementing corrective actions based on audit findings, thereby continually improving documentation practices

What is Role of Good Documentation Practices in Electronic Documentation and Data Integrity ?

With the advancements in technology, the transition to electronic documentation systems has become increasingly common in the pharmaceutical industry. However, careful consideration must be given to data integrity and security:

• There must be SOP for Electronic documentation
• Recognizing the benefits of electronic documentation, such as enhanced collaboration, searchability, and accessibility of information
• Implementing robust electronic document management systems (EDMS) that ensure data integrity, security, and compliance with regulatory requirements
• Implementing adequate controls to prevent data tampering, unauthorized access, and ensure the longevity and reliability of electronic records

What is Role of Good Documentation Practices in Record Retention and Archiving Practices?

Proper record retention and archiving practices are crucial for regulatory compliance and future reference. Key considerations include:

• Establishing and enforcing record retention policies and timelines in accordance with regulatory guidelines
• Archiving and storing documents in a secure and easily retrievable manner, utilizing appropriate storage media and backup systems
• Ensuring accessibility and retrieval of archived documents when needed, enabling timely audits, inspections, and response to customer inquiries

What is Role of Good Documentation Practices in Continuous Improvement?

To stay ahead in the ever-evolving pharmaceutical industry, continuous improvement in documentation practices is vital. Key steps to consider are:

• Regularly reviewing and updating documentation practices to identify areas for improvement, streamline processes, and enhance compliance
• Utilizing feedback and lessons learned to drive process enhancements and address any gaps or concerns in documentation processes
• Leveraging technological advancements to streamline documentation, embrace automation, and ensure seamless integration with other business systems

Do’s and Don’ts Related to Good Documentation Practices

Good Documentation Practices (GDP) play a vital role in maintaining accuracy, reliability, and compliance in any pharmaceutical industries. The following are the Do’s and Don’ts for creating effective documentation:

Do’s:

1. Be Clear and Concise:
   • Use simple, straightforward language to ensure the documentation is easily understood by everyone, regardless of their experience level.
   • Avoid jargon and overly technical terms unless necessary and always explain them.
2. Use Proper Formatting:
   • Organize your documents with headings, subheadings, bullet points, and numbered lists to enhance readability.
   • Include a table of contents for long documents to make navigation easier.
3. Ensure Accuracy:
   • Verify that all information is correct and factual. Mistakes in documentation can lead to costly errors.
   • If data is being recorded, ensure it is precise and timely.
4. Follow Standard Operating Procedures (SOPs):
   • Adhere to any internal or regulatory guidelines that dictate how documentation should be created and maintained.
   • Ensure consistency across all documents by following predefined templates and formatting rules.
5. Include Date and Time Stamps:
   • Always date documents and entries, including any changes or updates made, to provide a clear record of when the information was created or modified.
   • Record the time of actions taken, particularly in regulated environments.
6. Ensure Legibility:
   • Make sure handwriting, if used, is legible. Typed text should use a clear, readable font.
   • Avoid using colors or highlights that could reduce readability or cause confusion.
7. Maintain Version Control:
   • For documents that are revised or updated regularly, ensure there is a version control system in place to track changes over time.
   • Keep previous versions of documents archived for reference and audits.
8. Sign and Initial Appropriately:
   • For actions that require verification, ensure signatures or initials are added to confirm who created, reviewed, and approved the document.
   • Use electronic signatures where applicable for digital documentation.
9. Use Standardized Terminology:
   • Use consistent and standardized terminology throughout the document to avoid confusion.
   • If industry-specific terms are used, ensure definitions are included or well-understood by all readers.
10. Make Documents Accessible:

Don’ts:

1. Don’t Use Unclear or Ambiguous Language:
   • Avoid vague phrases or language that can be interpreted in multiple ways.
   • Do not use abbreviations or acronyms without first defining them.
2. Don’t Rely on Memory:
   • Always document information in real-time, especially for critical activities, rather than relying on memory later.
   • Late entries or “backdating” can cause issues during audits or inspections.
3. Don’t Leave Gaps or Blank Spaces:
   • Never leave blank spaces in a form or document. If a section doesn’t apply, mark it as “N/A” (not applicable).
   • Leaving blanks can cause confusion and questions about the integrity of the document.
4. Don’t Overwrite or Erase Information:
   • Never use white-out or attempt to erase entries. If an error is made, strike through the incorrect information, date and initial it, and provide the correct data.
   • In electronic documents, use a “track changes” feature or similar tool to show edits.
5. Don’t Use Unapproved Templates:
   • Avoid using templates that are not officially approved or standardized by your organization.
   • Ensure any new documentation formats undergo review and approval before use.
6. Don’t Skip Reviews or Approvals:
   • Always have documentation reviewed and approved by the appropriate personnel before finalizing or distributing it.
   • Skipping this step can lead to unverified or incorrect information being shared.
7. Don’t Overcomplicate:
   • Avoid adding unnecessary details that may overwhelm the reader. Focus on relevant and essential information.
   • Keep documentation as simple as possible while still capturing necessary data.
8. Don’t Ignore Regulations:
   • Failing to follow industry-specific regulatory requirements, such as Good Manufacturing Practices (GMP) or Good Clinical Practices (GCP), can result in non-compliance.
   • Always stay informed about the latest regulations and ensure documentation meets those standards.
9. Don’t Ignore Retention Requirements:
   • Be aware of the retention policy for documents. Don’t dispose of records or documents before the legally required period has passed.
   • If records need to be kept for a specific number of years, ensure they are archived properly.
10. Don’t Make Assumptions:

• Do not assume the reader knows the background information; provide enough context to understand the documentation.
• Clarify any assumptions or conditions mentioned within the document.

3 Examples of GDP (Good Documentation Practices) in Quality Control

Good documentation practices (GDP) play a unique role in QC to ensure compliance with regulatory standards and maintain product quality. Here are three examples of good documentation practices in pharma QC:

1. Clear and Consistent Record Keeping:
   • Ensure all QC test results, observations, and actions are accurately recorded. This includes date, time, batch numbers, test methods, and results.
   • Documents should be legible, and handwritten entries should be made in permanent ink, with any corrections appropriately initialed and dated (no erasures allowed).
   • Records must be stored in a way that ensures they are readily accessible and protected from damage, loss, or tampering. For instance, physical records should be in fireproof filing cabinets, while electronic records should be backed up regularly.
2. Standard Operating Procedures (SOPs):
   • Establish and adhere to detailed SOPs for all QC procedures, such as sampling, testing, equipment calibration, and result analysis.
   • SOPs should be regularly reviewed, and any changes should be documented, with the reasons for updates clearly stated. Employees must be trained and sign off to confirm they understand and follow the SOPs.
   • SOPs should also specify the documentation requirements, such as who is responsible for signing off on test results and when retesting is required.
3. Audit Trails and Traceability:
   • All QC documents should include complete traceability from raw materials to finished products, ensuring that each step in the process is linked to the appropriate records.
   • An audit trail must be maintained for any changes made to the documents (e.g., if a test result is modified, the reason for the change should be recorded).
   • These practices allow for transparency and accountability in the QC process, making it easier to trace any issues that may arise back to their root causes.

By following these practices, pharmaceutical companies can ensure compliance with regulatory requirements and maintain the integrity of their products throughout the QC process.

Conclusion

Good documentation practices play an important role in pharmaceutical development. It serves as a foundation for ensuring product quality, regulatory compliance, and patient safety. By prioritizing accurate, comprehensive, and accessible documentation, organizations can drive efficient operations, improve decision-making, and foster a culture of integrity and transparency. By adhering to regulatory standards, implementing efficient document creation and management processes, and ensuring accuracy and completeness in documentation, businesses can transform their operations.

You may also want to check out other articles on my blog, such as:

• What is the GMP?
• How to write a pharmaceutical monograph?
• Challenges related to pharmaceutical quality control?
• How to write SOP?
• What is the STP and how to design?

FAQs

What are the 7 criteria for high quality of documentation?

Concise, correct, complete, clear, compliant, consistence and codable

What are the 4 levels of documentation?

Quality manual, procedures, work instructions, and quality records

What are the consequences of poor documentation practices in the pharmaceutical industry?

Poor documentation practices can lead to compliance issues, compromised product quality, and patient safety concerns. It may result in regulatory penalties, product recall, and significant damage to the company’s reputation.

Can electronic documentation be as secure as physical documentation?

With the proper implementation of security measures, electronic documentation can be as secure as physical documentation. Encryption, access controls, and regular system audits can help safeguard electronic records from unauthorized access and data breaches.

How often should employee training on documentation practices be conducted?

Employee training on documentation practices should be conducted regularly to ensure ongoing compliance and understanding. The frequency may vary depending on the organization’s needs, but training should be conducted at least annually or whenever significant changes to documentation processes occur.

Abbreviations

• EDMS: Electronic document management systems
• SOP: Standard operating procedure
• GDO: Good documentation practice
• GLP: Good laboratory practices

References

• Indian pharmacopeia
• https://www.usp.org/events-training/course/good-documentation-practices-gdp-and-usp-nf-general-chapter-1029-demand#:~:text=Good%20Documentation%20Practices%20(GDP)%20is,a%20fully%20developed%20quality%20system.
• https://www.gmp-compliance.org/gmp-news/final-who-guidance-document-on-good-data-and-record-management-practices