SOP's are commonly confused with Electronic Batch Record work instructions; the difference is important; and they can work together to provide robust, compliant documentation that can differentiate a regulated product

1. SOP’s and Electronic Batch
Records for Production
Compared

2. SOP’s and EBR’s are often confused
• Per ICH(International Council on Harmonization), an SOP is a detailed,
written instruction to achieve uniformity of the performance of a
specific function. They are informed by the mandating guidelines of
regulatory entities.
• Electronic Batch Records provide the structure and means for
automatically compiling batch production data into an electronic
format.
• Most of the confusion comes from those entering regulated domains
for the first time, or within domains where the regulations are in the
process of completion

3. FDA, CDPH, etc. require SOPs for
Compliance
• Define requirements as
referenced by regulatory
authority guidelines, e.g.,
21 CFR Part 111.15 for
sanitation of physical plant
and grounds
• Should be available and
complete for regulatory
audits, etc.
• Should be read,
understood, and followed
by all applicable company
roles

4. SOP’s differ from EBR
Manufacturing Instructions
• SOP = regulatory directive for uniformity
• Manufacturing Instructions = process steps
in an Electronic Batch Record that transitions
(creates, extracts, packages, etc. ) a product
• Manufacturing instructions must follow
applicable SOP’s

5. SOP’s are especially effective when linked into
Electronic Batch Records
SOP-EBR LINKAGE BENEFITS
• Operations teams can easily check for
required action steps to complete during
real time production
• Production documentation clearly
illustrates connection to the regulatory
”mother lode” for an auditing entity,
customer, prospective contract agreement,
etc.

6. SOP Content Behind the Hyperlink………..

7. SOP’s and Electronic Batch Records work
together; both need direction and care
• Worksteps should be aligned to the guidelines when creating
production procedures in a Master Production Record
• Additions and revisions for your SOP’s and EBR’s should be tracked
• Batch record and SOP training for your teams should be recorded and
kept up to date.
• Timely ‘review and revise’ sessions can prove helpful if SOP’s and
EBR’s are configurable.