Negative pressure weighing room operation inspection record form – Recheck verification frequency (GMP compliance stratified standard)
I. First-level recheck: Operator self-inspection (every shift, immediate)
Frequency: After filling out the inspection record form, the operator must immediately self-check. This is a mandatory pre-process that cannot be submitted for review without completing the self-check. Scenario: At the end of each shift, the operator fills out the form and conducts on-site self-check immediately, confirming that there are no blank items, the data is correct, and the signature is complete.
II. Second-level recheck: Shift supervisor on-site recheck (every shift, before the end of the shift)
Frequency: Once per shift. All inspection records must be rechecked on-site on the same day. Cross-shift and cross-day rechecks are not allowed.
Requirements: Take the paper record to the weighing room for on-site comparison with the instrument and equipment status, and sign and return it after verification.
III. Third-level recheck: QA / Equipment administrator random recheck (parallel two frequencies)
1. Daily surprise recheck (daily supervision)
Frequency: Full coverage recheck every day. If there are multiple weighing rooms in the workshop, at least one recheck per day should be conducted; the monthly recheck should cover all shift records of all negative pressure weighing rooms in the workshop.
Form: Random on-site remeasurement of parameters, comparing the authenticity of the paper records for the day.
2. Monthly ledger comprehensive recheck (periodic ledger review)
Frequency: Once per month. After the completion of the entire inspection ledger for the month, QA / Equipment administrator should conduct a comprehensive recheck and verification of each ledger.
Work content:
Verify the continuity of the entire month’s records, check for missing pages, pre-filled, or proxy signatures;
Cross-link verification: Logical matching of inspection abnormal records, maintenance work orders, filter replacement records, and instrument calibration records;
Count the defects in the monthly records and form monthly training and rectification items.
IV. Annual recheck: Comprehensive review before audit (once a year)
Frequency: Before the GMP revalidation / drug regulatory audit of the previous year, conduct a complete recheck and verification of all inspection records.
Function: Sort out the defects and deviation closed-loop situations throughout the year, and form a summary report on equipment record management.
Summary concise version (can be directly written into SOP)
Operator self-check: Every shift immediately;
Shift supervisor on-site recheck: Once before the end of the shift;
QA daily random check: Randomly selected every day, full coverage of all equipment every week;
Monthly ledger comprehensive recheck: Once at the end of the month;
Annual archiving review and recheck: Once a year.
Add special scenario recheck requirements
In case of equipment failure, parameter exceedance, or deviation events: Additional special recheck, no fixed frequency, simultaneously verify all inspection records within the previous 3 days of the incident;
For new employees starting work independently 3 days before: Shift supervisor double recheck, each shift conduct secondary verification twice.