presentasi akhir pfizer_agam_linkedin
TRANSCRIPT
BY:AGAM BUDI SATRIA15/392820/FA/10759
PRESENTASI AKHIR PKPA INDUSTRIPT. PFIZER INDONESIA
OKT – NOV 2016
Click icon to add picture
- 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
Click icon to add picture
- THE MOST: PONSTAN- THE THICKEST: VISINE ORG- THE THINNEST: IMPORT PRODUCT
LHF FILINGPARTS OF LHF: RELEA
SED
VALIDATION
REJECTED
- 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,
PROCESS, COMM, COMP
Click icon to add picture
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 SYSTEMINTEGRATED BATCH RECORD AND RETAINED SAMPLE
Click icon to add picture
PFIZER HIGHER REGULATED, HAS TO BE REPORTEDREPORT DOCUMENTATION COMPLY CPOB, FACILITATING AUDIT
CAS REPORTFOR ANALYZING GAP BETWEEN PQS/SOP PFIZER WITH LOCAL REGULATORY (INDONESIA BADAN POM)
Click icon to add picture
QA’S KAIZEN PROJECT LHF ROOM OPTIMIZATIONLHF ROOM: PLACE FOR KEEPING DOCUMENTS WITH LIMITED ACCESS
KAIZEN PROJECTALL STAFFS HAVE TO BE
PARTICIPATING
KAIZEN PROJECT:LHF ROOM OPTIMIZATION
KAIZEN PROJECT: LHF ROOM OPTIMIZATIONPROBLEMSTO RAG E AR RAN G EM EN T IN LOT H IST ORY F I LE ( L HF ) R OOM PG S JA KARTA CUR R ENT LY:- ON LY B AS ED O N AVA I L AB LE RAC K LOC AT IO N W ITH OUT SP EC IF IC OR DER AND IDEN T ITY L AB E L - EXCESS M ATER IAL SU PP L IES W IT HOU T P R OP ER PL AC EM ENT. - NO SP EC I F IC M AR K T O SEPARAT E B ET W EEN STAG ING AR EA FOR L HF T O B E DEST R OYED AN D L HF T O B E F I L ED . - UNC LE AR FLOW FO R AN Y ACT IV I T Y ( F I L IN G LH F , P ULL ING AN D DES TR OY ING L HF , L END ING AND R ETU R N ING L HF )
IN L HF R O OM .
SOLUTIONIMPLEMENTS 5S :- SORT : MOVE IT OUT- SET IN ORDER : E V E RY T H I N G I N I T S P L AC E- SHINE : INSPECT FOR CLEANING- STANDARDIZE : MAKE UP THE RULE- SUSTA IN : DURABLE , DA ILY WORK, MAKE IT HAB IT.
THE END