Audit template in the LeanSuite app
Last reviewed
Pharmaceutical line clearance audit checklist
Audit of line clearance practice in regulated production.
The full question list
The 7 questions in the audit
Every question is answered Yes, No or N/A. Each No is flagged and asks for a photo and a comment, so the finding arrives with its evidence.
Clearance
- 1Previous batch material is removed
- 2Documents are removed or reconciled
- 3Equipment is cleaned and labelled
- 4Second person verified
Records
- 5Record is complete and signed
- 6Deviations reported
- 7Audit signed
When to use it
- Every day, before first use or at the start of the shift.
- An auditor or leader answers each question from what they see, hear and read in the area.
- Each record starts with: Line.
How it is scored
The template is built with points per answer and a pass mark of 80. In this library every audit is set to pass at 80 and every inspection at 90. Each submitted audit shows its score and pass or fail, and every No is flagged with its photo and comment.
Change the points or the pass mark after you clone it. How rules and scoring work.
Read and print
More in quality and food safety
- Line clearance verification9 questions
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- Allergen control audit checklist10 questions
Use this template in LeanSuite
It is ready in the Template Marketplace inside Lean Creator as “Pharmaceutical Line Clearance Audit”. Clone it into your plant, change any question, then schedule it to a person, role or asset with reminders. Auditors complete it on a phone or tablet, with photo evidence where required.
Not on LeanSuite yet? On a 90-day pilot our team sets up your account and digitizes the forms and checklists you use today, this one included.