3. - REVIEW LHF DAN FILING
- IBAS SYSTEM
- CAS REPORT: EXPIRED DATE
- KAIZEN PROJECT: LHF ROOM
- APR VISINE
- JOB AID: HOLDING TIME
STUDY
- PCOM: PFIZER COMPLAINT
- GRN FILING: PFIZER & JNJ
LEARNING OUTCOME
OBTAINED:
QUALITY
OPERATION
4. - THE MOST: PONSTAN
- THE THICKEST: VISINE OR
- THE THINNEST: IMPORT
PRODUCT
HF FILING
PARTS OF LHF:
RELEASE
D
VALIDATI
ON
REJECTE
D
- AVG SFG
- NO MORE ED?
- DEDICATED SHELF
• LHF COVER
• COA + FPIS
• CC
• QAP
• MP (YIELD, CONTROL
CHART)
• PI (YIELD, A+B)
• “TO WASH” CARD
• LABEL
• PHARMACY WEIGHT
• QAR (CONDITIONALLY)
- AVG 3 LOT
- PFIZER PROSPECTIVE
- TS: VALIDATION: PCK, PROC
COMM, COMP
5. OBJECTIVE: COMPLY WITH DATA
INTEGRITY PRINCIPLE (ALCOA
LEGIBLE, ORIGINAL, ACCURATE )
ADVANTAGES:
- ELEKTRONIK DATA DURABLE, UP
TO DATE, LOWERING RISK FOR MISSING
DOCUMENTS
- CLOUD COMPUTING QO
SHAREPOINT
- HELPS TRACKING, EASING DATA
GATHERING APR, DESTROY
SCHEDULING , RETAINED SAMPLE
MONITORING
IBAS SYSTEM
INTEGRATED BATCH RECORD AND
RETAINED SAMPLE
6. PFIZER HIGHER REGULATED, HAS TO BE REPORTED
REPORT DOCUMENTATION COMPLY CPOB, FACILITATING AUDIT
CAS REPORT
FOR ANALYZING
GAP BETWEEN
PQS/SOP PFIZER
WITH LOCAL
REGULATORY
(INDONESIA
BADAN POM)
7. QA’S KAIZEN PROJECT
LHF ROOM OPTIMIZATION
LHF ROOM: PLACE FOR
KEEPING DOCUMENTS WITH
LIMITED ACCESS
KAIZEN
PROJECTALL STAFFS HAVE TO BE
PARTICIPATING
9. KAIZEN PROJECT: LHF ROOM OPTIMIZATION
PROBLEM
STORAGE ARRANGEMENT IN LOT HISTORY FILE (LHF) ROOM PGS JAKARTA CURRENTLY:
- ONLY BASED ON AVAILABLE RACK LOCATION WITHOUT SPECIFIC ORDER AND IDENTITY LABEL
- EXCESS MATERIAL SUPPLIES WITHOUT PROPER PLACEMENT.
- NO SPECIFIC MARK TO SEPARATE BETWEEN STAGING AREA FOR LHF TO BE DESTROYED AND LHF
TO BE FILED.
- UNCLEAR FLOW FOR ANY ACTIVITY (FILING LHF, PULLING AND DESTROYING LHF, LENDING AND
RETURNING LHF) IN LHF ROOM.
SOLUTION
IMPLEMENTS 5S:
- SORT : MOVE IT OUT
- SET IN ORDER : EVERYTHING IN ITS PLACE
- SHINE : INSPECT FOR CLEANING
- STANDARDIZE : MAKE UP THE RULE
- SUSTAIN : DURABLE, DAILY WORK, MAKE IT HABIT.
