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
- Process mapping
- Authoring
- Formatting and language
- Editing
- Authorizing
- Training
- Implementation
- 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
- A general information we previously mentioned that need to be on each page:
- 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
- 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