Standard Operating Procedure for Laboratory Notebook Management
1) Purpose
This SOP outlines the procedures for maintaining laboratory notebooks to ensure accurate, complete, and traceable documentation of experimental procedures, observations, and results in pharmaceutical research and development.
2) Scope
This SOP applies to all laboratory personnel responsible for maintaining laboratory notebooks within the pharmaceutical facility, ensuring compliance with regulatory requirements and good documentation practices.
3) Responsibilities
The Laboratory Manager or designated personnel are responsible for overseeing notebook management procedures. Laboratory scientists and technicians are responsible for maintaining and documenting entries in laboratory notebooks.
4) Procedure
4.1 Notebook Setup and Format
- Assign a unique identifier (e.g., notebook number, initials) to each laboratory notebook.
- Define and document the format for entries including headings, date format, signature and dating practices, and any required annotations.
4.2 Documentation of Entries
- Record all experimental procedures, observations, calculations, and results directly in ink in the laboratory notebook.
- Include sufficient detail to allow another scientist to replicate the experiment or understand the rationale for deviations.
4.3 Review and Approval
- Review and approve entries by a designated scientist or supervisor to verify accuracy, completeness, and compliance with procedures.
- Implement procedures for correcting errors, including crossing out with a single line, dating, and providing an explanation.
4.4 Storage and Access
- Store laboratory notebooks in designated secure locations to prevent loss, damage, or unauthorized access.
- Establish procedures for controlled access and retrieval of laboratory notebooks for review, audits, or continuation of experiments.
4.5 Retention and Archiving
- Establish retention periods for laboratory notebooks based on regulatory requirements and company policies.
- Archive laboratory notebooks in accordance with established procedures for historical reference and future audits.
5) Abbreviations, if any
SOP: Standard Operating Procedure
6) Documents, if any
Laboratory Notebook Format Template, Notebook Review and Approval Form, Notebook Retention and Archiving Policy
7) Reference, if any
Regulatory guidelines such as FDA Guidance for Industry: Good Laboratory Practice for Nonclinical Laboratory Studies, ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, USP General Chapter 1029 Analytical Instrument Qualification
8) SOP Version
Version 1.0
