Checklist BatchProductionRecords

CHECKLIST: BATCH PRODUCTION RECORDS
MANUFACTURED CANNABIS SAFETY BRANCH
A Batch Production Record is a detailed documentation of the work performed to manufacture or remediate a
batch of cannabis product. Batch production records include information about the cannabis and non-cannabis
ingredients used, the staff member(s) who completed each step, verifications that the Master Manufacturing
Protocol was followed, and information about the quality control processes used to ensure safety.
The checklist below will assist in verifying that your batch production records capture the minimum required
information. A complete list of requirements can be found in section 40258 of the regulations.
CHECKLIST FOR BATCH PRODUCTION RECORDS
OVERALL INFORMATION
The manufacturing premises where activity occurred - Including the name, license number and location
of the premises
The identity of the product being manufactured
INGREDIENTS
The unique identifiers (UIDs) of the cannabis and cannabis products used in the batch
The identity, identification numbers and weight or measure of all cannabis and non-cannabis
ingredients used – Records of which raw ingredients were used in which production batches are
important when tracing is needed, such as when a supplier issues a recall. A common way of tracking
ingredients is by using the lot numbers assigned by the ingredients’ manufacturer.
EQUIPMENT AND PROCESSING LINES

Identification numbers of equipment and processing lines used - Major equipment and processing lines
that play a crucial role in the production of the batch should be given identification numbers, and those
numbers should be recorded in the batch production record. The intent of this requirement is to identify
equipment that plays a crucial role in manufacturing of a cannabis product, where if the equipment
malfunctioned, the cannabis product would not meet quality or safety standards.
Maintenance, cleaning and santitizing logs (or a reference to where these logs can be found) – These
should include the date the activity was performed and the name of the staff member who completed
the cleaning or maintenance.
PRODUCTION STEPS
The date on which each step of the Master Manufacturing Protocol was perfomed
The signature or initials of the person who performed each step. This includes the person who weighed or
measured each component, who added each component to the batch, and who verified the addition of
components
www.cannabis.ca.gov www.cdph.ca.gov/mcsb [email protected]

V.1--9.14.2020 Page 1 of 2
CHECKLIST: BATCH PRODUCTION RECORDS
MANUFACTURED CANNABIS SAFETY BRANCH
PRODUCTION STEPS (CONTINUED)

Expected yield and actual yield – These values should be recorded at key stages of processing, such as after
extraction, post-processing or refinement, after producing infused product, and/or when cannabis product is
packaged in retail-ready form.
PACKAGING AND LABELING

A copy of the label and package (or a reference to label and package documented in the Master
Manufacturing Protocol)
Expected number of packages and labels to be used
Actual number of packages and labels used
QUALITY CONTROL STEPS

Results of monitoring, testing or verification activities – These are activities performed to ensure
product safety or quality and may include monitoring of temperature, time of activity, or volume or
weight; homogenization; operating parameters for extraction equipment; quality assurance testing; etc.
Quality control review – Documentation that quality control personnel reviewed the batch production
record, monitoring operations, tests and examinations
Quality control approval – Documentation that quality control personnel approved/released or rejected
the finished cannabis product and the batch for distribution
Documentation of any material review and disposition
FINISHED PRODUCT
The UID of the finished product
The batch or lot number of the finished product
The Certificate of Analysis for finished product – This is added to the Batch Production Record after
regulatory compliance testing is completed
KEY POINTS TO REMEMBER

• Records must be accurate and legible
• The documentation captured in a batch production record occurs when the activity is performed.
• Batch production records contain the actual values and observations obtained during the production,
monitoring and verification processes.
If you have any questions about these regulatory requirements, please email us: [email protected].
www.cannabis.ca.gov www.cdph.ca.gov/mcsb [email protected]

V.1--9.14.2020 Page 2 of 2

Checklist BatchProductionRecords

Uploaded by

Copyright:

Available Formats

Checklist BatchProductionRecords

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Checklist BatchProductionRecords

Uploaded by

Copyright:

Available Formats

CHECKLIST: BATCH PRODUCTION RECORDS

MANUFACTURED CANNABIS SAFETY BRANCH

CHECKLIST FOR BATCH PRODUCTION RECORDS

EQUIPMENT AND PROCESSING LINES

www.cannabis.ca.gov www.cdph.ca.gov/mcsb [email protected]

PRODUCTION STEPS (CONTINUED)

PACKAGING AND LABELING

QUALITY CONTROL STEPS

KEY POINTS TO REMEMBER

www.cannabis.ca.gov www.cdph.ca.gov/mcsb [email protected]

You might also like