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

1. Assign a unique identifier (e.g., notebook number, initials) to each laboratory notebook.
2. Define and document the format for entries including headings, date format, signature and dating practices, and any required annotations.

4.2 Documentation of Entries

1. Record all experimental procedures, observations, calculations, and results directly in ink in the laboratory notebook.
2. Include sufficient detail to allow another scientist to replicate the experiment or understand the rationale for deviations.

4.3 Review and Approval

1. Review and approve entries by a designated scientist or supervisor to verify accuracy, completeness, and compliance with procedures.
2. Implement procedures for correcting errors, including crossing out with a single line, dating, and providing an explanation.

4.4 Storage and Access

1. Store