SOP Guide for Pharma

SOP for Documentation and Record Keeping in Preclinical Studies

SOP for Documentation and Record Keeping in Preclinical Studies

Standard Operating Procedure (SOP) for Documentation and Record Keeping in Preclinical Studies

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for documentation and record-keeping in preclinical studies. Proper documentation and record keeping are essential to ensure compliance with regulatory requirements, maintain data integrity, and support the reproducibility and traceability of study results. This SOP outlines the procedures for managing study documents, ensuring that all records are accurate, complete, secure, and accessible for review or audits.

2) Scope

This SOP applies to all personnel involved in the preparation, handling, storage, and archiving of documents and records related to preclinical studies. It includes guidelines for maintaining raw data, study protocols, reports, correspondence, and any other documentation generated during the course of the study. This SOP is relevant to study directors, project managers, regulatory affairs personnel, quality assurance (QA) staff, and all team members involved in study documentation and record-keeping activities.

3) Responsibilities

  • Study Directors: Oversee the documentation and record-keeping process, ensuring that all records are maintained according to internal protocols and regulatory guidelines.
  • Project Managers: Coordinate documentation activities and ensure that all documents are completed on time, reviewed, and filed appropriately throughout the study lifecycle.
  • Regulatory
Affairs Personnel: Ensure that documentation practices comply with regulatory requirements and are suitable for submission to regulatory authorities.
  • Quality Assurance (QA): Review and audit study documentation and records to ensure compliance with Good Laboratory Practice (GLP) and other relevant guidelines.
  • Laboratory Technicians: Ensure that raw data, experimental notes, and observations are recorded accurately and legibly, and that documentation is kept up to date.
  • 4) Procedure

    The following steps outline the procedure for documentation and record keeping in preclinical studies:

    1. Step 1: Documentation Preparation
      1. Ensure that study documentation is prepared in accordance with the study protocol and regulatory requirements.
      2. Documents should be clear, complete, and accurate, reflecting all aspects of the study process, including objectives, methodologies, data collection methods, and results.
      3. Ensure that each document includes identifying information such as study ID, study title, version number, and date of preparation.
    2. Step 2: Record Keeping
      1. Ensure that all records, including raw data, observations, study protocols, and laboratory notebooks, are legibly written or electronically recorded.
      2. Data entries should be made in real-time and should be corrected promptly when errors are detected. Corrections should be made by striking through the error and adding the correct information along with the date and initials of the person making the change.
      3. Ensure that all records are traceable and that each document or entry is linked to a specific study or experiment. This may involve linking data to sample IDs or batch numbers.
    3. Step 3: Review and Approval
      1. All documents should be reviewed for completeness, accuracy, and compliance with the study protocol before final approval.
      2. Study directors, regulatory affairs personnel, and other relevant stakeholders should review and approve all study documents, including raw data, final reports, and any amendments to the study protocol.
      3. Ensure that any changes to documents are documented and that the rationale for changes is provided. These changes should be approved by the study director and other appropriate personnel.
    4. Step 4: Document Storage and Access
      1. Store study documents and records securely to prevent unauthorized access or tampering. This includes both physical storage (e.g., file cabinets) and electronic storage (e.g., password-protected databases or document management systems).
      2. Ensure that all records are readily accessible to authorized personnel, including for audits or regulatory reviews. Records should be organized in a manner that allows for easy retrieval.
      3. Ensure that records are stored for the appropriate length of time according to regulatory requirements and company policies. This may vary depending on the type of document and regulatory jurisdiction.
    5. Step 5: Data Integrity
      1. Ensure that all data is maintained in a way that protects its integrity. This includes ensuring that raw data are not altered or destroyed and that data can be easily traced back to its original source.
      2. Ensure that any deviations from the study protocol or procedures are documented and explained. This includes recording any unexpected occurrences or technical difficulties that might affect the study outcomes.
    6. Step 6: Record Archiving
      1. Ensure that all completed study documents are archived in accordance with company policies and regulatory requirements. This includes both physical and electronic records.
      2. Establish a clear retention schedule for all study records, including raw data, correspondence, study reports, and audit trails. This schedule should comply with applicable regulations and guidelines, including GLP and ICH standards.
      3. Ensure that archived records are protected from physical damage, environmental factors, and unauthorized access. Use secure storage systems and ensure periodic checks for integrity.
    7. Step 7: Sample Disposal
      1. Dispose of all biological samples, chemicals, and laboratory waste in accordance with biosafety and waste disposal regulations.
      2. Ensure that hazardous materials are disposed of in designated biohazard or chemical waste containers to minimize environmental impact.

    5) Documents

    The following documents should be maintained during the documentation and record-keeping process in preclinical studies:

    1. Study Protocols
    2. Raw Data Logs
    3. Study Reports
    4. Audit and Review Records
    5. Deviation and Corrective Action Records
    6. Correspondence and Communication Logs
    7. Waste Disposal Records

    6) Abbreviations

    • GLP: Good Laboratory Practices
    • FDA: Food and Drug Administration
    • QA: Quality Assurance
    • ICH: International Council for Harmonisation
    • CAPA: Corrective and Preventive Action

    7) References

    References to regulatory guidelines and scientific literature that support this SOP:

    • OECD Guidelines for Good Laboratory Practice (GLP)
    • FDA Guidelines for Preclinical Safety Testing
    • ICH E6 Good Clinical Practice Guidelines
    • ICH Q10 Pharmaceutical Quality System Guidelines

    8) Version

    Version 1.0: Initial version of the SOP.

    9) Annexure

    Documentation and Record Keeping Template

    Document ID Document Title Version Number Approval Date Storage Location
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