SOP – Standard Operating Procedure best practice

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SOP

International Conference on Harmonization (ICH) defines a Standard Operating Procedure (SOP) as “detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55). It is Founded in Federal regulations (GXP) guidelines

SOP – Common Characteristics

  • Lists general information that is to be utilized throughout any process (not too detailed)
  • Describes the regularly recurring operations relevant to quality of the task
  • Its purpose is to carry out the operations correctly and always in the same manner. 
  • Examples : 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
  • Infrequently go through changes
  • Are controlled, regulated documents which should be available at the point of use. 

SOP – Importance & Benefits

  • Fulfills compliance obligations as it Incorporates regulations, Best Practices, and institutional requirements applicable to the product and procedure to fulfill compliance, guarantees compliance at a systemic level
  • Helps in maintaining operational efficacy by ensuring uniform process flow for an optimized results irrelevant to the location or performer
  • Helps in training staff uniformly to optimize quality of product and/or study
  • Standardization of the common processes company-wide and maintain of a certain level of accountability for the performers

Difference between SOP and MOP (Manual of Operation)

  • MOP is a handbook of instructions to guide the operator to successfully carry out a study or procedure according to the protocol.
  • These are extremely detailed.
  • They are study-specific and incorporate elements of the SOP
  • These go through multiple changes throughout the life time of the study and are updated based on modifications

SOP – Initiation for creating a SOP

You need to have an SOP in place for initiation procedure and further steps for preparation, implementation, and management of the documents (including SOPs)

This should address:

  • Who can make SOPs and What types of SOPs are they responsible for
  • Who should draft the proposal for SOPs
  • Who should receive the proposals for an SOP
  • The procedure for approval
  • Who is responsible for the date of implementation
  • Who should be informed
  • Who is responsible for SOP distribution, filing, administration
  • How revisions / corrections need to be requested / applied
  • How to revise an SOP
  • How frequently an SOP should be periodically evaluated and the responsible party
  • How to withdraw an SOP

SOP – Steps & Best Practices

  1. Process mapping
  2. Authoring
  3. Formatting and language
  4. Editing
  5. Authorizing
  6. Training
  7. Implementation
  8. Revision/Archiving

Download

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1- Process Mapping :

  • Start with regulations, guidance, and institutional policies applicable
  • Lay out all the steps currently used to complete the task
  • Mapping of each step in the task (more efficient, easier to follow)
  • Document what needs to be documented, resolved, reported, how to handle deviations, and violations
  • Set up a meeting with all the parties involved in the process
    • Choose the best author
    • Agree on what to be included
  • Set up a future meeting to discuss the first draft of SOP and capture comments
  • Test the mapping and see if it is easy to follow and effective
  • Set up a date for the final approved version

2- Authoring :

Select the best author who is typically:

  • A person who has the knowledge and experience in the procedure
  • A person who does the procedure is the best

3 – Formatting and Language :

  • Choose your format:
    • Simple Step
    • Hierarchical Steps
    • Flowchart
  • Each page of an SOP should have a heading / footing including:
    • Date of approval / revision No.
    • A unique Title that can also be abbreviated
    • The SOP No. with the SOP category:
      • Fundamental
      • Apparatus
      • Analytical method
      • Procedure for a special project
      • Protocol (sequence of actions)
      • Organizational
      • Personal matters
      • Registration form (i.e., for chemicals / samples)
      • Worksheet (i.e., for analytical procedures, …)
    • Page No. with the total No. of pages in the SOP
    • Heading should be preferably printed in another color than black
  • The minimum sections to consider for an SOP are:
    • Title
    • Purpose statement
    • Policy statement, definition of terms and roles/responsibilities
    • Steps to complete process
    • Original version number and date
    • Revision date
    • Effective date
    • List of content specially for long SOPs
    • Instructions and procedures:
      • Scope and applicability
      • The equipment, reagents (including grade, potency), … with appropriate detail
      • Methodology and procedures
      • Clarification of terminology
      • A criteria for control of the systems used during the procedure
      • Health and safety warnings
      • Equipment and supplies
      • Cautions and interferences
    • Author signature and date
    • Authorizer signature and date
    • Appendices
    • References
  • The first page (Title page) should at least mention:
    • A general information we previously mentioned that need to be on each page:
      • Date of approval / revision No.
      • A unique Title that can also be abbreviated
      • The SOP No. with the SOP category:
      • Page No. with the total No. of pages in the SOP
      • Heading (or logo alone) should be preferably printed in another color than black
    • A summary of the content:
      • Purpose
      • Application
    • Any related SOPs
    • Potential safety instructions
    • Author’s name and signature
    • Approving authority’s name, title, signature
  • The language should be clear:
    • Use short, active sentences with command verbs
    • Use simple words
    • Use instructional tone
  • Keep your sentences as short as possible
  • Break up large chunks of text with diagrams and flowcharts
  • Put tasks in correct order as it is supposed to be performed
  • Use titles for the performer not names
  • Limit the number of steps per page
  • Use enough space in between steps
  • Include timelines for completion of tasks
  • Reference other forms or templates if needed

Download:

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4 – Editing :

The group who originally met, should review and comment:

  • Circulate the first draft of SOP
  • Set a time to gather the comments
  • Arrange a meeting to discuss and reach consensus on proposed changes
  • Revise the draft SOP accordingly
  • Recirculate among the group
  • Ask for feedback by a certain date
  • Incorporate feedback to finalize SOP
  • Have another member from the team to do a check for quality assurance

5- Authorizing :

  • The author/authors should sign the SOP and date it
  • The person in charge of the process should also sign and date
  • The quality control manager also needs to sign and date

Distributing :

  • Administrator responsible for distribution / archiving SOPs could be:
    • Quality Assurance Manager
    • Personnel and Organization Manager
    • Lab manager
    • Any other appropriate party
  • The administration to be reflected on:
    • Log book
    • Computerized database:
      • PerfectView
      • Cardbox
  • The data to be stored by the SOP administrator include:
    • SOP No.
    • Version No.
    • Date of issue
    • Date of expiry
    • Title
    • Author
    • Status (submitted, in drat, draft ready, issued, approved)
    • Department of holders / users
    • Names of holders / users
    • Number of copies per holder
    • Registration No. of SOPs that are referenced in the SOP
    • Historical data including date of previous issues
  • Place the hard copy of the original signed SOP in the SOP binder
  • PDF the signed original and keep in a safe location
  • Choose a place to post the PDF version of the SOP for reference:
    • Cloud
    • Server
    • Internet/intranet
    • E-mail
    • Paper
  • Identify the individuals who are part of the process:
    • Send notification that there is a new SOP
    • Make sure they are trained for it
    • Document their training

6 – SOP Training :

  • All staff who is some how related to the product need to be trained on relevant SOPs
  • Have the author train other team members
  • Choose the best training set up:
    • Group training
    • One-on-one
    • Self-paced e-learning
  • Training should be documented
  • SOPs should be available to the staff at all time at the point of use

7 – SOP Implementation :

You need to define:

  • Who is responsible to implement the SOP
  • What happens if there is a deviation in the SOP
  • How to check the SOP was followed
  • Who is responsible for all these?

8 – Revision & Achieving :

  • There should be a formal documented revision process in place
  • This revision process should include:
    • A designated member of the team to manage the process
    • A secured document management system (DMS)
    • A policy as to when the revisions need to be done:
      • On a rolling basis
      • At established time points
      • Both
  • When updated, the old versions need to be archived for reference:
    • Keep all hard-copy signed originals in the SOP binder
    • Label the old versions as Archived
    • Remove the old PDF versions from circulation and replace it with the new version