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Risk Management Plan

The Risk Management Plan outlines strategies to identify, evaluate, control, and monitor risks in the production, packaging, and quality control of sterile drug products. It details potential risks, their impacts, and corresponding control measures for various risk areas, including equipment failure, environmental contamination, operator errors, and material defects. General strategies include adherence to ICH Q9 principles, regular training, and a system for corrective and preventive actions.

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zestyflauxy
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35 views2 pages

Risk Management Plan

The Risk Management Plan outlines strategies to identify, evaluate, control, and monitor risks in the production, packaging, and quality control of sterile drug products. It details potential risks, their impacts, and corresponding control measures for various risk areas, including equipment failure, environmental contamination, operator errors, and material defects. General strategies include adherence to ICH Q9 principles, regular training, and a system for corrective and preventive actions.

Uploaded by

zestyflauxy
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Risk Management Plan

Scope
This plan covers Production and Packaging of Sterile Drug Products
and Materials and Product Quality Control and Assurance (QA/QC) to
identify, evaluate, control, and monitor risks that could impact product
quality, patient safety, and regulatory compliance.

1️⃣Production and Packaging Risk Management Plan


Control
Risk Area Potential Risk Risk Impact Measures Monitoring
Equipmen Incomplete Batch Preventive Maintenanc
t failure filling, improper rejection, maintenance, e logs,
sealing contaminati equipment calibration
on qualification records
Environm Microbial Product Cleanroom Environme
ental ingress during sterility classification, ntal
contamina aseptic failure HEPA filtration, monitoring
tion processing air monitoring reports
Operator Incorrect filling Product Training, SOP Routine
error volume, recall, adherence, audits,
mislabeling patient double checks deviation
harm reports
Packaging Leaking Product Incoming QC of Batch
material vials/ampoules, integrity packaging packaging
defect poor label compromise materials, inspection
adhesion d supplier audits reports
Power Incomplete Production Backup power Incident
failure batch, loss, data supply (UPS, reports,
during equipment loss generator), power
productio reset batch recovery system
n plan checks

2️⃣Materials and Product Quality Control and Assurance


Risk Management Plan
Control
Risk Area Potential Risk Risk Impact Measures Monitoring
Raw Use of Product Supplier Material
Control
Risk Area Potential Risk Risk Impact Measures Monitoring
material substandard failure, qualification, release
non- raw material regulatory COA review, records,
conforma non- incoming QC supplier
nce compliance testing review
Sampling Inaccurate False batch Follow sampling QC audit of
error representation acceptance/ SOPs, use sampling
of batch quality rejection trained practices
personnel
Lab Incorrect test Release of Test method QC result
testing results (e.g., non- validation, review,
error assay, sterility) conforming analyst training, proficiency
product double testing
verification
Data Misrecording of Regulatory Electronic data QA
integrity results, action, integrity document
lapse incomplete product controls, audit review,
documentation recall trails internal
audits
Delay in Extended batch Supply chain Defined testing KPI reports,
testing release disruption timelines, QA review
timelines resource of release
planning timeline

General Risk Management Strategies


 Application of ICH Q9 (Quality Risk Management) principles

 Risk assessments (e.g., FMEA) conducted for major process steps

 Regular training and requalification of staff

 Periodic review of risk controls and updating of mitigation plans

 Deviation and CAPA (Corrective and Preventive Action) system in place

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