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Standard Operating Procedures: Their Importance and Key Regulatory Requirements


    Almost every deficiency identified in FDA's 483s and Warning Letters can be traced back to deficiencies in Standard Operating Procedures (SOP) at a given organization. The top 10 reasons for FDA's 483 related to SOPs include:

    • Procedures not followed
    • Investigations of discrepancies, failures
    • Absence of written procedures
    • Deficiencies in scientifically sound laboratory controls
    • Deficiencies in control procedures to monitor and validate performance
    • Written procedures not established / followed
    • Calibration/inspection / checking not done
    • Deficiencies in training operations, GMPs, written procedures,
    • Deficiencies in cleaning / sanitizing / maintenance
    • SOPs not followed / documented

    What do you think? Are SOPs really important - Not only to plan consistent manufacturing or testing operations repeatedly but also to ensure that your Quality Control (QC), Quality Assurance (QA), and production units use them to assure the accuracy of the original product development?

    What You Should Know

    Some companies overlook the importance of writing SOPs or policies and procedures. However, consider the benefits.

    SOPs Help Fulfill Regulatory Obligations
    Companies that pay attention to the importance of SOPs are likely to fulfill compliance obligations by incorporating regulations, best practices, and institutional requirements to the product and procedure.

    For clinical trials specifically, SOPs ensure that the research conducted within clinical sites adheres to the Federal regulations, ICH-GCP, and institutional policies to safeguard the human study participants' welfare and rights.

    SOPs Help Maintain Operational Efficiencies
    Through their efforts to prepare SOPs effectively, companies ensure uniform process flow for optimized results no matter what the location is or who the performer is. SOPs contribute to the standardization of processes company-wide and help minimize errors.

    SOPs Help Train Staff
    Effective SOPs assist in training staff uniformly to optimize the quality of the product and/or study. The presence of documented step-by-step procedures will help in teaching staff how to carry out things effectively to get optimized results and enhance awareness and working knowledge. SOPs provide an excellent source for training new employees.

    What You Can Do

    Ensure the Three Main Classes of Procedural Documentation
    Regulatory bodies require organizations to have formal documentation describing their Business, Quality, and Compliance practices. The three key procedural documentation types include policies, procedures (SOPs), and work instructions.

    Make Sure That All Types of SOPs Are Included

    • Fundamental SOPs
    • Methodic SOPs
    • Safety precaution SOPs
    • Operating instruments / apparatus / equipment SOPs
    • Analytical method SOPs
    • Reagent preparation SOPs
    • Sample receiving / registration SOPs
    • Quality assurance SOPs
    • Archiving / Complaint SOPs

    If Deviations Are Allowed, Clearly Define the Conditions
    Define and document the conditions if they are allowed including who can provide permissions for this and what should be the complete procedure. Place the original SOPs in a secure place and authenticate the working copies with stamps and/or signatures of authorized persons

    Key Requirements
    • 21 CFR 211.100 Written Procedures; Deviations There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
    • 21 CFR 11 requires organizations to have policies, procedures, and work instructions, including:
      • Computer validation (21CFR 11.10(a))
      • System backup & recovery (21CFR 11.10(c))
      • Data archiving (21CFR 11.10(c))
      • Business continuity (disaster recovery) (21CFR 11.10(c))
      • Granting system access & computer system security (21CFR 11.10(d).100, .200, 300)
      • Training & training documentation (21CFR 11.10(i))
      • Use of electronic signatures (21CFR 11.10(j))
      • Document control (21CFR 11.10(k))
      • System operation and maintenance (21CFR 11.10(k)(l))
    • 21 CFR 312.53: The investigator will "ensure that all associates, colleagues, and employees assisting in the conduct of the study (ies) are informed of their obligations in meeting the above commitment."
    • The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4: Documentation: "Procedures: (Otherwise known as Standard Operating Procedures, or SOPs), give directions for performing certain operations."
    • ICH-GCP 2.13: "systems with procedures that assure the quality of every aspect of the trial should be implemented."

    Related Training

    How to Prepare a Standard Operating Procedure (SOP)?

    Write it Right - Excellent SOPs for Improved Quality and Compliance

    Writing Effective and compliant SOPs

    Best Practices of Writing SOPs

    Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)

    SOP Development for Medical Device Firms: Utilizing ''lean compliance'' principles to meet your quality system documentation requirements

    How to write SOP's that Avoid Human Error

    Creating Effective SOPs for Regulatory Compliance

    Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site

    How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA

    Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

    Improving Sanitation Standard Operating Procedures In the Food Industry