Standard Operating Procedure
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What is an SOP?
Who should Write?
Format and Content of SOPs
How to Implement
Managing Change Control
Who is Responsible?
Who looks at them?
Standard Operating Procedures
(a.k.a. SOPs)
• Documents that describe a specific procedure in
detail
• Living documents that represent current practice
• Official documents that can be used in court.
Signed approvals indicate responsibility.
• FDA requirement as stated in the drug cGMPs
(CFR 21 Parts 210 & 211)
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In fact . . .
• SOPs are mentioned 23 times in the drug GMPs
– “There shall be written procedures . . . “
– “Such written procedure shall be followed . .“
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SOP’s are important because
• They provide a written record of a specific
procedure
• They can be used as a training tool
• They provide the FDA with evidence that
company is in control of there procedure &
processes
• They make good business sense
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When do you need to write an
SOP?
• GMP regulations specify some instances.
However, additional procedure relating to the
development and/or manufacture of drug
products should also be in SOP format
• SOPs are not intended to restrict experimental
activities in the product development process
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Getting Started . . .
• Identify individual or group responsible for the
process
• Agree on a format (template) and or process for
review, approval, and distribution of the
documents (write an SOP for SOP’s)
• Identify procedures to be written
• Assign writing responsibilities to appropriate
individuals
• Review and solicit comments as needed until the
document is acceptable
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SOP Format
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Header
Body
Footer
Attachments
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SOP Header
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Title
SOP Number (XXX-YYY-ZZ)
Effective Date
Approvals (document, control, writer,
manager/supervisor, QA or GMP coordinator)
• Other information
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SOP Body
• Purpose – the reason for writing the SOP
• Scope – the limitations of the procedure
• Responsibility – positions responsible for
specific parts of the procedure
• Procedure – step by step instructions
• Documentation – necessary to support the
procedure
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SOP Footer/Attachments
• The SOP must be paginated
• Attachments – part of the SOP or separate?
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Tips . . .
• Write clearly and concisely avoiding excessive
detail
• Avoid using jargon unless absolutely necessary
• Watch grammar and spelling – use of shall, will,
should, can
• Be careful referencing other SOPs
• Be careful with attachments and forms
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Maintaining SOPs
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Document Specialist
Quality Assurance/Quality Control
Change control
Availability and distributions of copies
– Paper copies
– Electronic copies
• Training
• Periodic Review
• Archiving
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Finally . . .
• It is a concern if an SOP is not in place
• It is a violation if a SOP is in place but not
followed
• Map out what you need to accomplish
• Set realistic goals for writing/prioritize
• Utilize learning from other areas
• Assess the quality and relevance of SOPs
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