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Rakhmat Budi Yuwono (Pharmacist)
06 September 2017
Pekan Ilmiah Tahunan (PIT) IAI 2017
KNOWLEDGE SHARING
MANAJEMEN RESIKO MUTU
QUALITY RISK MANAGEMENT
AN IMPLEMENTATION
Australian Code of GMP for Medicinal Product
• 45 words RISK
European Guide to GMP
• 54 words RISK
WHO WHO : Annex 4 GMP For Pharmaceutical Products,
• 16 words RISK
• Various words : risk due to inadequate safety, quality and efficacy, risk to quality, risk of error, risk of mix-up, risk of cross contamination, risk of microbial contamination, risk of manipulations, risk to the product, etc
In various words
Product Life Cycle – Risk - Patient
Pharmaceutical
Development
Technology
Transfer
Commercial
Manufacturing
Product
Discontinuation
Patients
US
Friends
Parents Brother
Sister
Manufacturing and use of a drug product
involve some degree of risk.
Effective Quality Risk Management (QRM)
ensure the high quality of the drug product
Proactive means to identify and control
potential quality issues
improve the decision making if a quality
problem arises.
facilitate better and more informed
decisions
Provide regulators with greater assurance of
a company’s ability to deal with potential
risks
Introduction…..(1)
Basic Principles
The evaluation of the risk to quality
should be based on scientific knowledge
and ultimately link to the protection of
the patient; and
The level of effort, formality and
documentation of the quality risk
management process should be
commensurate with the level of risk.
Introduction…..(2)
7 | Q-Risk
Management | April
24 | Business Use
Only
Advantages as Process
• Improves decision making
– Identifies what gives most benefit to the
patient
• Is scientific & data-driven
– Reduces subjectivity
• Ranks risk - allows prioritization
– Better use of resources
• Means of building in Quality
• Improves transparency - inside organisation
and builds trust with competent authorities
– Enables regulatory flexibility
• Benefits apply throughout product lifecycle
Harm:
Damage to health, including the damage
that can occur from loss of product
quality or availability (ICH Q9).
Risk:
The combination of the probability of
occurrence of harm and the severity of
that harm (ISO/IEC Guide 51).
What is RISK ?
Risk Management (ISO 14971, 2007):
A systematic APPLICATION of management
policies, procedures, and practices to the tasks of
analyzing, evaluating, controlling and monitoring
risk.
Quality Risk Management (ICH Q9):
A systematic PROCESS for the assessment, control,
communication and review of risks to the quality of
the drug (medicinal) product across the product
lifecycle.
What is (QUALITY) RISK MANAGEMENT ?
Level People Compliance
5 High
Membahayakan jiwa Customer/Employee atau menyebabkan cacat permanen
Menyebabkan Recall & izin edar dicabut/perizinan perusahaan dicabut
4 ↓
Menyebabkan cacat sementara pada employee/pasien menderita namun masih dapat disembuhkan
Menyebabkan Recall namun masih memiliki izin edar/major variation
3 Medium Menyebabkan penurunan fungsi tubuh pasien/employee
Menyebabkan produk tidak dapat digunakan/minor variation-prior approval
2 ↓
Berefek terhadap ketidaknyamanan pasien/karyawan
Menyebabkan Complaint dari Customer/minor variation-notifikasi
1 Low Tidak ada resiko kepada Customer/Employee
Tidak ada resiko perizinan
SEVERITY
Level Kemungkinan Frekuensi Kegagalan
5 High ≥ 1 kejadian dari 2
cycle
f > 1/10
4 ↓ Sering terjadi 1/10 ≤ f > 1/100
3 Mediu
m Terjadi beberapa kali
1/100 ≤ f >1/10.000
2 ↓ Terjadi kadang-kadang 1/10.000 ≤ f > 1/100.000
1 Low Jarang sekali terjadi ≤ 1/1.000.000
PROBABILITY
Level Kemungkinan Terdeteksinya Kegagalan
5 High Tidak dapat dideteksi melalui sistem/visual
4 ↓ Berisiko tidak terdeteksi melalui sistem/visual
3 Medium Dapat dideteksi melalui sistem/visual setelah
terjadi
2 ↓ Selalu terdeteksi pada saat terjadi
1 Low Selalu terdeteksi sebelum terjadi
DETECTABILITY
5
4
3
2
1
1 2 3 4 5 6 7 8 9 10
Occurrence : Probability + Detectability
S
e
v
e
r
i
t
y
Risk Control
Accept w/ Risk Control
Accept w/ Risk Control based on Priority
RISK EVALUATION –EXAMPLE A
16 | Q-Risk
Management | April
24 | Business Use
Only
Not a means of removing industry’s obligation
to comply with regulatory requirements
Justification of product or process failures
People have to think and not simply follow
black and white rules
Pre-determined outcome of assessments
Not applicable in situations where decisions
allow no flexibility (regulatory requirements)
Not embedded in an overall quality systems,
stand alone activity
BE AWARE OF ….(1)
17 | Q-Risk
Management | April
24 | Business Use
Only
Lack of training on tools
Improper composition of teams performing
the risk assessments – lack of scientific
knowledge, relevant data not assessed, lack
of process knowledge
Decision makers and stakeholders not
informed
Writing half of (or hiding) facts or information
BE AWARE OF ….(2)
Existing internal Documentation System
Where to be in future?
(Mission, Policy)
What to do? (e.g. Directives)
How to do? (e.g. Guidelines)
Detailed instructions (e.g. Standard Operating Procedures) Records
Quality Risk Management
(QRM)
Rules & Procedures (internal regulations)
Records & Reports
Implementation Approach
HOW’S RISK MANAGEMENT GIVE
MEANING IN DEVIATION HANDLING
Scope
Any events where there is conditions or process
parameter or product that DOES NOT MEET the
approved requirement and specification
20
3
2
All Process
1
Product Released & Post Production Monitoring
C4.03
DRF
Melaporkan penyimpangan
Originator
FR-C4.0554, PT-C4.0093
01
Follow up laporan & Identifikasi penyimpangan
Process Owner
DRF, PT-C4.0093
Register dan review penyimpangan
Compliance Specialist
DRF, Database, PT-I2.0007
Risk Management
I2.07
RMF
Tentukan akar masalah yg menjadi penyebab
ketidaksesuaian yg terjadi
Process Owner
PT-I2.0007, PT-C4.0200
Deviation
Apakah kategori
penyimpangan major atau
kritikal?
Ya
1Tidak
INTEGRATE RISK MANAGEMENT
21
4
7
5
6
All Process
3
Tentukan tindakan perbaikan yang akan dilakukan
Process Owner
DRF, PT-I2.0007, PT-I2.0010
01
Risk Management
I2.07
RMF
Corrective & Preventive Action
I2.04
CAPA Form
Review penyimpangan & correction plan serta approval
Deviation Form
Compliance Mgr/QM
DRF, PT-I2.0007, PT-I2.0010
Menganalisa kebutuhan untuk melakukan extended
investigation
Compliance Mgr
DRF, PT-I2.0007, PT-I2.0010
Change Control
C4.09
CC Form
Implementasi correction
Process Owner
DRF, Dokumen Pendukung
Verifikasi hasil implementasi
Compliance Mgr/QM
DRF, Dokumen Pendukung, Database
Melakukan trending secara periodik
Compliance Mgr
PT-C4.0156, FR-C4.0415, Database
Corrective & Preventive Action
I2.04
CAPA Form
02
2
1
03
Deviation
• Implement Deviation Record/Incident
• Simplifying Minor Deviation Handling
– One Day Root Cause Analysis & Finalized
– Reduce Lead Time
– Strengthen QA Inspector Role
• Analyzed Reoccured Deviation
– Finalized CAPA from deviation
– Risk Analysis (Accept residual risk or not)
HOW’S RISK MANAGEMENT GIVE
MEANING IN CALIBRATION
All measuring devices
calibrated withouth
risk assessment
Interval of calibration
have defined
normative
No procedure to
determine either
measuring devices
needs to be calibrated
or not by reviewing
criticality measuring
device based on the
influence of measuring
device performance on
product quality
Increase the amount
of measuring device
must be calibrated
continuously
Increase calibration
activities, lead to
improper in calibration
management system
risk prioritizing,
calibration schedule
calibration procedure
accuracy result
Risk to patient safety
and regulatory
compliance.
0
500
1000
1500
2000
2500
2014 2015 2016
Measuring Devices
Calibration Activities
DEVICES AND CALIBRATION ACTIVITIES
BACKGROUND
An organization which is not unlimited resources, so
it needs to optimize the resources for calibration
activities with improving quality risk management on
calibration policy
PURPOSE
This document describes an assessment approach
that should be applied to evaluate measuring
device criticality and define required calibration
intervals or frequencies.
BACKGROUND AND PURPOSE
5 4 4 4 5 5
4 3 3 4 4 5
3 2 3 3 4 4
2 1 2 3 3 3
1 1 1 2 3 3
1 2 3 4 5
Risk Evaluation Score :
3 : Low
4 : Medium
5 : High
Needs to be calibrated
No needs to be calibrated but verification, include
in Preventive Maintenance
No needs to calibrated
RISK EVALUATION-STAGE 1
5
4
3
1 2 3 4 5
Level Calibration Frequency
Innitialy, monthly and verification before used
Innitialy and every 3 months
Innitialy and every 6 months
Innitialy and every 12 months
Innitialy and every 24 months
stability calibration result extended calibration
period
4th calibration pass 2 period calibration
3rd calibration pass 1 period calibration
RISK EVALUATION-STAGE 2
6685.5
6183.5
5900600061006200630064006500660067006800
w/o RA with RA
Man Hour
Reduce 6%
man hour/year
RESULT
Kategori Materi Evaluation Training
High 1 tahun 2 tahun
Medium 2 tahun NA
Low 3 tahun NA
HOW’S RISK MANAGEMENT GIVE
VALUE IN TRAINING MANAGEMENT
No
Competency Matrix Type S P D Risk Level
1 5R, Sanitation & Hygiene Basic GMP 4 2 3 High
2 Granulasi Specific Operation 4 2 3 High
3 Serah Terima & Rekonsiliasi RM/PM
General Operation 3 1 2 Low
4 Pengenalan Alur Proses Solida General Operation 3 1 3 Medium
Operator
No
Competency Matrix Type S P D Risk Level
1 5R, Sanitation & Hygiene Basic GMP 4 2 3 High
2 Packing Specific Operation 4 2 3 High
3 Serah Terima & Rekonsiliasi RM/PM
General Operation 3 1 3 Medium
4 Pengenalan Alur Proses Solida General Operation 3 1 2 Low
Petugas Kemas