BY:AGAM BUDI SATRIA15/392820/FA/10759

PRESENTASI AKHIR PKPA INDUSTRIPT. PFIZER INDONESIA

OKT – NOV 2016

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- 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

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- 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

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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

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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)

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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