Scribd
Upload
7 views

harin Vachhani

The document discusses risk management and deviation handling in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), highlighting key components and regulatory guidelines. It outlines risk management tools such as FMEA, Risk Matrix, and HAZOP, as well as the importance of addressing deviations to maintain product quality and compliance. Additionally, it details types of deviations and the corrective and preventive actions required for effective management.

Uploaded by

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

harin Vachhani

The document discusses risk management and deviation handling in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), highlighting key components and regulatory guidelines. It outlines risk management tools such as FMEA, Risk Matrix, and HAZOP, as well as the importance of addressing deviations to maintain product quality and compliance. Additionally, it details types of deviations and the corrective and preventive actions required for effective management.

Uploaded by

harinvachhani
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 10

RISK MANAGEMENT AND

DEVIATION HANDILING IN
GMP/GLP

PRESENTED BY – HARIN VACHHANI


DEPARTMENT OF CHEMISTRY
M.SC SEM - 2 , ROLL NO - 7
LJ SCHOOL OF APPLIED SCIENCE
OVERVIEW OF GMP/GLP

Good manufacturing practice (GMP)


GMP ensure products are consistently produced and controlled to quality
standards.
Key Components: Products, processes, procedures

Good laboratory practice (GLP)


GLP ensure that laboratory studies are properly planned,performed,monitored,
and reported.
Key Components: Documentation, Sampling, Testing

2
KEY ELEMENTS OF RISK MANAGEMENT

Risk Risk Risk Risk


identification Assessment identification monitoring and
(equipment Using tool like ( preventive review
failure,human FMEA , HAZOP maintenance,training,
error,contamination) SOPs)

3
REGULATORY GUIDELINES FOR RISK
MANAGEMENT

ICH Q9 (Quality Risk Management)


A framework for risk management in the pharmaceutical industry, evaluating, and
controlling risks.

FDA and EMA Guidance


FDA and EMA encourage a risk based approach to GMP and GLP , importance of
understanding risks to ensure product quality and safety.

ISO 14971
international standard for risk management for medical devices that can also
applied in pharmaceutical and laboratory settings.

4
RISK MANAGEMENT TOOLS AND
TECHNIQUES

FMEA (Failure Modes and Effects Analysis): - A systematic method for evaluating
potential failure points in processes or systems.

Risk Matrix: - A tool used to evaluate the likelihood and severity of risks, helping
prioritize actions.

HAZOP (Hazard and Operability Study): - A structured technique to identify potential


hazards in processes.

Root Cause Analysis (RCA): - A method used to identify the underlying causes of
deviations and failures

5
WHAT IS DEVIATION HANDILING IN GMP/GLP?

Definition: The process of identifying,


investigating, and resolving deviations from
established procedures or specifications in
a GMP/GLP environment.

Importance: Handling deviations promptly


and appropriately ensures that non-
compliance or errors do not compromise
product quality, safety, or regulatory
compliance.

6
TYPES OF DEVIATIONS

Planned Deviations: - Deviations that are pre-approved and documented


for specific situation. (e.g., temporary equipment change).

Unplanned Deviations: - Deviations that occur unexpectedly and must be


investigated (e.g., equipment malfunction, human error).

Critical Deviations: - Serious deviations that can affect product quality,


safety, or regulatory compliance.

Minor Deviations: - Less severe deviations that do not directly affect


product quality but still require documentation.

7
Corrective and Preventive Actions (CAPA)

Identification Investigation

DEVIATION
HANDILING PROCESS

Documentation Approval and Closure

8
REGULATORY REQUIREMENTS FOR
DEVIATION HANDILING
FDA 21 CFR Part 211 (GMP Regulations): - Requirements for handling
deviations and maintaining proper documentation of investigations and
actions.

EMA Guidelines: - Similar requirements for documenting and addressing


deviations in the pharmaceutical industry.

ICH Q10 (Pharmaceutical Quality System): - Emphasizes the need for


continuous improvement and effective deviation handling as part of the
quality management system.

9
1
0

You might also like