An audit checklist that remain static over the years, may well reflect an ineffective inspection, analysis and detection procedure.
The Pivotal Batch Audit Checklist. Checklist
Do's:-♦ Divide audit checklist into representative sections portraying each operation, manufacturing and control procedure.
♦ Add new check points to the list, when a new error or omission arises.
♦ Test the checklist, by evaluating routine production batches, to get a sense of possible omission categories.
♦ Break multiple check points into individual audit items on the checklist.
♦ Carefully cross-reference hand-written dates and times on the production forms against machine print-outs that have immediately follow the operational step.
♦ Remember - weighing, pH, HPLC and temperature print-outs and charts normally give the date and the exact time of the operation or test procedure.
♦ Evaluate production yields and adherence to time-limitation against . 2
T
P R O C E D U R E S
CHECKLIST FOR AUDITING THE
PIVOTAL PIVOTAL
BATCHProduct Name: Dosage Strength; mg
Batch No. Date of Audit: / /YY
Page 1 of 3.
Yes No 1. PRODUCT MASTER DOCUMENTS
ü Master documents approved and signed by appropriate personnel. q q ü Master documents available during the audit for comparison. q q
2. ACTUAL BATCH DOCUMENTS (Executed Batch)
ü Are the batch documents equivalent to the Master documents and available for the audit?
q q
ü Is the batch size equal or greater than 110,000 units? q q
ü Are the batch document pages numbered correctly?
ü Evaluate whether some of the pages could be replaced or rewritten?
q
q q
q ü Is there any evidence of erasures or white-outs?
ü Are cross-outs legible and correctly signed and dated ?
q
q q
q
3. PRODUCT MASTER FORMULA - Check MF ü Batch number
ü Lot No of ingredients
ü Two Signatures and date(s) for each weighing
ü Check ingredients weigh-out sheets
ü Computer weighing print-outs show gross, tare and net weights.
ü Are print-outs available and accurate?
q
4. BATCH MANUFACTURING INSTRUCTIONS - Check BMI for
ü Batch numbers recorded in correct data fields
ü ID numbers for Processing Machine present
ü Signatures and date(s) for each separate processing step
ü pH figures correct and are in the specification limit
ü Weight of processed material and yield calculation performed
ü % yield conform to written specifications limits on BMI
q
5. PRINT-OUTS & ATTACHMENTS - Check for full identification:
ü 'Equipment Cleaned' labels attached to batch record
ü In-process LOD print-outs recording target moisture achieved
ü In-process weight sheets/print-outs recording in-process yields
ü Recording charts for phase temperature (mixers / kettles etc.)
ü Recording charts for time of mixing (mixers/kettles).
q
P R O C E D U R E S
CHECKLIST FOR AUDITING THE
PIVOTAL PIVOTAL
BATCHEdition Number: Effective Date APPROVED
Product Name: Dosage Strength; mg
Batch No. Date of Audit: / /200Y
Page 2 of 3.
6. ROOM PREPARATION - Check for:
ü Machine Card details corresponds to batch record
ü Room Preparation Card details and dates correct
ü Check that card dates coincide with batch record dates.
ü If equipment was used in 2 sublots, were both entries recorded?
Yes
7. BATCH RUN SHEETS - Check Production sheets for:
ü All Product details are complete as per product Specifications.
ü Work station approved as clean and initialed before opening.
ü Opening of Production Work station initialed.
ü Operator and QC in-process control charts separate & identified.
ü Transferred of numbers are correct to BATCH SHEETS.
ü Operator and QC in-process on-line check results within the specifications limits set.
ü Number of in-process checks according to current SOP.
ü In-process sampling during manufacturing as per protocol.
8. INSTRUCTIONS FOR SEMISOLID FILLING Check for:
ü All Product details are accurate, including Lot No. of empty Tubes / Caps / Applicators.
ü Minimum, maximum and average empty tube weight
ü Minimum, maximum and average theoretical fill weight
ü Minimum, maximum and average of filled tube weight
ü Signatures of Production and Quality Control personnel
9. GENERAL MANUFACTURING INSTRUCTIONS ü Check continual stirring of suspension premixes :
ü All Product entries are complete - including sub lot number.
ü Preheating of Purified Water to 950C for NLT 45 min.
ü Mixer parameters set-up (settings, type, distance, angle)
ü Temp/Time Recording procedures including equipment graph.
ü Percentage yield conforms to specifications and within limits.
ü Summary of manufactured sub-lots (where appropriate).
q
P R O C E D U R E S
CHECKLIST FOR AUDITING THE
PIVOTAL PIVOTAL
BATCHProduct Name: Dosage Strength; mg
Batch No. Date of Audit: / /200Y
Page 3 of 3.
10. STANDARD PACKAGING SHEET - Check for:
ü Product details required for packaging operation complete.
ü Lot numbers present of packaging components.
11. PACKAGING CONTROL SHEET - Check:
ü All Product details required & entered are accurate
ü Cleanliness check of work station is approved
ü Product and packaging material identification is approved
ü Approval for start-up of the line
ü In-process control checks complete
ü Packaging 100% completion check
ü Quantity of the packaged product compared to the estimates
ü Sample of labels used with Lot No and Expiration Date
ü In-process QC checks of product packs
ü Representative sampling of each pack type and pack size.
12. PACKAGING MATERIALS BALANCE - Check for:
ü All Product details are accurate on reconciliation form
ü Labels are reconciled and printed material balance correct
ü Production and QA Signatures complete and dated.
Yes
13. PRODUCTION & PACKAGING SHEET - Check for:
ü All Product details required & entered are accurate
ü Yield reconciliation of each stage of manufacture
ü Time limitation at each stage of production in specification
ü Authorization signature of Quality Control Manager
q
14. MANUFACTURING DEVIATION REPORT - Check MDR for:
ü All Product descriptive details are entered accurately
ü Full description of the deviation
ü Source of process deviation
ü Proposed solution stated precisely
ü Decision on batch disposition confirmed
ü Authorization of Quality Assurance Unit
q