Pharmco Products Work Instructions Template - Free Download
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Pharmco Products Work Instructions Template
Pharmco Products Work Instructions Template
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Work Instruction WI01041: Batch Record Instructional
rev 1.1, RD 10/04
Purpose: To provide instruction for Pharmco Products’ procedure for using the new batch
record (form P001, rev. 4.0). An annotated batch record is included with this
work instruction to further describe the information required in its various
sections.
All manufacturing of final products is completed before the end of the Production
Department shift, not the next day.
All sign-offs must be with the initials of the person performing the operation or function.
Sign-offs are to occur in this order: [1] Start of Batch Record, [2] Production operators,
[3] QC, [4] QA.
All unused spaces must be filled in with “N/A”. Unused sections may be crossed out
with one line and then initialed.
“Start” Section
The batch record is started by VP-Production, VP-Quality/Sales or other trained personnel
The start date is the date the document was begun.
The quantity of chemical to be manufactured is given as: gallons of bulk, cases x bottle size,
drum size, IBC size or any other type of container used.
The customer’s name and PO number are included if the final product is manufactured
specifically for that customer.
In House Environment
The production date is the date of manufacture of the final product.
Chemicals
The names and lot numbers of all chemicals used in the manufacture of the final product are
listed.
The target net weight is the weight the particular formula calls for. Use form P009 ‘Weight
Variances for Chemicals by Container Type and Volume’ for the appropriate variance when
weighing chemicals. In the case of pure final product, the weight measured is the amount of
gallons per the customer’s PO.
The container is weighed first, then the scale is tared and the chemical is weighed. Both
weights are written on the batch record.
The gross weight (container + chemical) is written on the batch record.
Work Instruction WI01041: Batch Record Instructional
An ISO 9001:2000
Certified Company
The Promise of Purity
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source: pharmcoaaper.com
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