QUALITY MANAGEMENT
SYSTEM
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About Quality Management System (QMS)
What is QMS?
• This is a system which is designed to implement
the system procedure for delivering the quality
product.
• It ensures the implementation of procedure and
practices at site for effective implementation of
quality product.
• Quality Assurance is function which ensure the
implementation of quality management system at
site.
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Sub-parts of QMS:
QMS can be categorized into the
following sub-parts:
• Change Control
• Deviation
• Incident
• Market Complaint
• CAPA
• OOS / OOT
• Lab Incident
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DEVIATION
Definition:
Departure from the actual written instructions or standard
procedures is known as deviation.
Aim:
It aims to observe any stage of receipt, handling, storage,
processing, testing, manufacturing, packaging, systems and
documents involved in the product manufacturing.
Goal:
The goal of a change control procedure usually include minimal
disruption to services, reduction in back-out activities, and cost-
effective utilization of resources involved in implementing change.
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DEVIATION
Types:
Critical Deviations: Those deviations which are likely
to have significant impact on quality of product or
regulatory commitment or are due to critical failure of
the systems.
Major Deviations: Those deviations that could have a
significant impact on quality of product or regulatory
commitment or indicate failure of a system.
Minor Deviations: Those deviations which are unlikely
to have any detectable impact on quality of product or
regulatory commitment or less serious observation/
isolated incidence which do not indicate system failure.
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CHANGE CONTROL
Change control can be described as a set of six steps:
Plan / Scope
It include identifying the change, its owner(s), how it will be communicated and executed and
its target date for completion.
Assess / Analyze
It include impact and risk assessment for analyzing the changes.
Review / Approval
To review whether the changes are required and approval of the change for further action.
Build / Test
It include the execution process after approval of the change. The team will execute through a
small-scale development process in test or development environments. This allows the team an
opportunity to design and make incremental changes.
Implement
The team will implement the change not only according to the approved plan but also to
organizational standards, industry standards, and quality management standards.
Close
The closing process is one of the more difficult and important phases of change control. It
include all the proofs of supporting documents and final evaluation of the change.
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CHANGE CONTROL
Flow chart for the change control is as follows:
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CHANGE CONTROL
CHANGE CONTROL CLASSIFICATION:
➢ Minor Change:
• These changes have minimal effect to the, identity, strength, quality, purity or potency of
drug product as these factors must relate to safety or effectiveness of drug product.
• Example: Correction of Typographical error in SOPs/BMR/BPR etc., which does not
impact on SISPQ.
➢ Major Change:
• These changes have moderate impact to the, identity, strength, quality, purity or potency of
drug product as these factors shall relate to safety or effectiveness of drug products or
triggers validation / qualification /stability studies.
• Example: Addition or deletion of a step or addition of an alternative/new step in the
formulation manufacturing process as per validation / APQR recommendation.
➢ Critical Change:
• The changes have potential effect on the product quality / regulatory bodies according to
respective guidelines i.e. Changes except annual notification requirement.
• Example: Addition of a new manufacturing site with modification of the formulation
manufacturing process described in the original dossier/document.
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CHANGE CONTROL
➢ CHANGE CONTROL NUMBERING PATTERN: (For reference)
The numbering system for change control request shall be as follow:
A/CRF/NNN/EE
A : Area code of Alembic Pharmaceuticals Ltd, Sikkim.
CRF : Change Request Form
NNN : indicates three digit numerical format number allocated
in incremental manners starting from 001 from each
calendar year.
EE : indicates two digit year.
➢ TRENDING OF CHANGE CONTROL: QA shall prepare trending of change control on half yearly
basis.
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CONCLUSION
➢It is the key responsibility of each and every individual whoever working
in Pharmaceutical Industry to follow QMS during their routine work in
Industry. Every change effort carries with it potential risks. However,
with adequate planning, those risks can be avoided and or managed.
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