QMS Principles
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Quality
Good
Quality
Manufacturing Management
Assurance Practices
6
Quality Control
• A set of quality assurance guidelines
and standards particularly in the
production, manufacturing, and
distribution of pharmaceuticals,
Good medical devices, and certain
What is GMP? Manufacturing cosmetics.
• GMP defines a framework for
Practices
ensuring the consistent and safe
production of products to meet the
quality, safety, and efficacy of
products in regulated industries.
Find the difference between QA and QC.
• A systematic approach to ensuring that
products or services consistently meet
specific quality standards and customer
expectations.
• Involves the development and
Quality implementation of processes and
What is QA? Assurance practices to prevent defects, errors, or
variations in the final output.
• Quality assurance aims to create a
framework in which quality is built into
every stage of a process rather than
being inspected or corrected after
production.
• A reactive process that involves
monitoring, measuring, and testing
What is Quality the quality of a product to ensure it
Quality Control meets the defined quality standards.
Control? • It’s a system of maintaining standards
by testing a sample of the output
against the specification.
• The strategic or organizational level (quality
policy, objectives, and management and usually
produced as the Quality Manual).
• The tactical or functional level (general practices
such as training, facilities, and operation of QA)
• The operational level (Standard Operating
Procedures (SOPs) worksheets and other aspects of
day-to-day operations)
Quality Statement
Quality Policy
Quality Manual
SOP’s
Manufacturing
Instructions
Forms
Log Books
Test Sheets
Quality Pyramid
What is the P-D-C-A Cycle?
PLAN
• The ‘Plan’ section of the process approach tackles what to
do and how to do it.
• This is the largest part of the cycle.
• It helps an organisation establish quality policy, objectives,
targets, controls, processes, and procedures that will help
them to achieve the results they need, in line with the
organisation's overall policies and business plan.
DO
• The ‘Do’ section of the process approach focuses on the
‘doing’.
• It works to implement and operate the quality policy,
strategies, and procedures that have been planned.
CHECK
• The ‘Check’ section of the process asks: ‘Did everything
happen according to the plan?’
• It drives the monitoring and review of performance
against the quality policy and objectives and reports
results to management for review.
• In turn, top management of the organisation are
expected to determine and authorise actions for
correction and improvement.
ACT
• During 'Act', we ask: 'How can you improve next time?'
• This section of the process aims to maintain and
improve the QMS by taking corrective actions based on
results from the management review.
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1. Role of a QMS in maintaining consistency in product batches in the pharmaceutical industry.
• Standardization
• Documentation and Record Keeping
• Quality Control (QC) Testing
• Training
• Continuous Monitoring
• Corrective and Preventive Actions (CAPA)
2. The impact of quality management on the pharmaceutical product lifecycle - from R&D to market release.
• During R&D
• Scale-up to Manufacturing
• Clinical Trials
• Regulatory Review and Approval
• Commercial Manufacturing
• Post-market Surveillance
How QMS can streamline processes to reduce cycle time for pharmaceutical manufacturing?
• By enforcing standardized procedures -> which reduce variability and inefficiency,
leading to a decrease in cycle time.
• Ensures compliance with regulatory standards, which can prevent costly rework or
delays due to regulatory non-compliance.
Challenges and solutions in aligning QMS with varying international pharmaceutical
regulations.
• Variability in International Standards
• Keeping Up-To-Date with Changing Regulations
- Regular training and updates, as well as engagement with regulatory bodies and industry groups, can help
companies stay informed of the latest requirements
• Differing Interpretations of Regulations
- Seeking clarification from regulatory authorities and possibly hiring or consulting with experts who specialize in
regional regulatory affairs can aid in alignment.
• Resource Constraints
- Leveraging technology solutions like QMS software, which can provide scalable and cost-effective compliance
support, can help mitigate resource constraints.
1. QMS facilitate an environment of continuous improvement
• Established a structured framework for identifying, analyzing, and improving processes and products.
• Encourages regular reviews, audits, and feedback loops that highlight areas for enhancement.
2. Metrics to measure Continuous Improvements
• process efficiency
• customer satisfaction rates
• defect rates
• cycle times
• audit outcomes
Integrating risk management into a QMS can:
• Proactively identify potential issues through risk assessments.
• Implement preventative measures to mitigate identified risks.
• Enhance decision-making based on risk analysis, focusing resources where most needed.
• Foster a culture of safety and quality, prioritizing risk reduction.
• Ensure regulatory compliance by addressing potential risks proactively.
• Improve product design and processes through continuous risk evaluation.
• Reduce the likelihood of product defects and non-compliance, decreasing recall occurrences.
QMS can drive customer satisfaction in terms of drug efficacy, safety, and availability by:
• Ensuring consistent product quality and reliability.
• Facilitating compliance with regulatory standards, ensuring product safety.
• Implementing continuous improvement processes to enhance drug efficacy.
• Adopting robust quality control measures to prevent contamination and errors.
• Ensuring timely and efficient production and distribution for better availability.
• Collecting and responding to customer feedback for ongoing improvement.
• Promoting transparency and accountability throughout the drug manufacturing process.
Debate the direct and indirect impacts
of customer feedback on QMS
processes in the pharmaceutical
industry.
Debate the direct and indirect
impacts of customer feedback
on QMS processes in the
pharmaceutical industry.
