Quality Management System for Pharmaceutical Industry (1)

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Quality
Management System for Pharmaceutical Industry
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Agendai

• About Pharmaceutical Industry
• Pharmaceutical Manufacturing Operations
• Challenges in Pharma Sector
• Reasons of quality failure in pharma industry
• What is Quality Assurance Why it is Important?
• Importance of a Quality Management System
• What is a Pharma QMS?
• Core Principles of a QMS
• Features Benefits of a Pharma QMS
• How Does It Help?
• Why BM Quality Master is the preferred choice?

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About Pharmaceutical Industry
Industry that works in the matter of
researching, innovating, developing, and
manufacturing of drugs and medications to speed
up the treatment process.
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Typical Pharmaceutical Manufacturing Operations
Typical Pharmaceutical Manufacturing Operationst
Source- Report of Small Business Industry
Assistance (SBIA)
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Challenges in Pharma Sector

• Supply chain disruptions
• Inefficient data collection storage
• Lack of agility transparency
• Compliance issues with the changing industry
  standards
• Excessive production turnaround time
• High costs of Research Development and
  Innovation
• Maintaining various dosage forms
• Human error customer Satisfaction

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Reasons of Quality Failure in Pharma
Manufacturing

• In pharmaceuticals, process deviation or quality
  failure could endanger the health of the
  patient. This can also result in regulatory
  violation that ends up with fines and an
  expensive market setback. Here are most common
  causes of pharmaceutical quality failure are
• Contamination (Especially in batch production)
• Equipment failure due to delayed maintenance
• Inappropriate flow of data
• Absence of written procedure
• Imprecise formulation

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What is Quality Assurance Why
It Is Important?

• Quality assurance is on of the important aspects
  of the drug manufacturing industry. It prevents
  organizations from getting caught in the legal
  penalties of regulatory bodies. The prominent
  objectives of quality assurance are
• Ensuring publics safety
• Preventing brand defamation
• Increasing product efficiency continually
• Helping to meet compliance standards
• Ensuring good clinical practice for trials

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Importance of a QMS for Pharma

• A quality management system helps organizations
  to run as effectively as they can to produce
  exceptional results. Automation of processes
  helps pharma businesses to increase productivity
  reach their goals in-time. Here are the
  reasons why it is beneficial to install a QMS It
• Lessens the risk of errors
• Cuts costs by minimizing the waste
• Keeps companies compliant
• Enhances customer satisfaction with high-quality
  products
• Helps maintain brand image by eliminating recalls

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What is a Pharma QMS?

• A Quality Management Software is a managerial
  approach towards drug manufacturing that helps
  manufacturers to instill a quality culture
  ensuring all products are meeting the required
  quality standards.
• It checks all the critical stages of drug
  manufacturing, including

Formulation
Method development
Facilities
Utility system
Equipment
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Core ISO Principles of a QMS

• A Quality Manufacturing System is a comprehensive
  software that works adopting all of the below
  mentioned quality-control practices.
• Increasing Customer Focus
• Efficient Resource Management
• Installing a Standard Processing Approach
• Maintaining Continuous Improvement
• Establishing Effective Communication
• Risk Assessment
• Evidence-Based Decision Making

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Features of a Pharma QMS
An efficient competent pharmaceutical quality
management system instills a customer- focused
culture, boosts operational efficiency, and
incorporates other QMS principles for highly
regulated industries. Here are some prominent
labor-saving features of a pharmaceutical
QMS Non-Conformance - Identify, document,
investigate, and discard the non-conformities. C
APA - With this module, the users can address
underlying quality issues and execute
containment actions to prevent recurring. Complai
nt Management - Very important in todays
customer-oriented environment, this module of
QMS can register, track, resolve, and close
customers quality complaints.
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Features of a Pharma QMS
Training Management - This capability of a QMS
upskills the companys staff by automating
training procedures and fosters continuous
improvement within the organization. Change
Management - From initiating change requests to
evaluating, implementing, verifying, and
closing, this module helps manage every step of
the change control process. Document Management
- To manage the whole lifecycle of every
document from creating, storing, tracking,
retrieving, etc. this module is essential.
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Features of a Pharma QMS
Compliance Management - To automate alerts for
loopholes potential issues to manage
compliance, this module helps companies to stay
compliant with the stringent SOX, FDA, and ISO
guidelines. Risk Management - Crucial to all
business, this module identifies, categorizes,
and assesses risks proficiently, and helps
eliminate it permanently. Audit Management - To
provide insightful business data to automate
streamline the process of audits.
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Benefits That a QMS for Pharmaceutical Provides

• Promotes effective and faster execution of
  processes adhering to the CGMP norms
• Increases customer satisfaction with precise
  manufacturing
• Elevates brand value by adhering to safety
  standards
• End-to-end traceability to reduce waste and
  speed recalls
• Increases efficiency by improving supply chain
  performance
• Enhances safety by reducing risks

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Why BM Quality Master is the preferred choice?

• BM QualityMaster is a powerful and easy-to-use
  Total Quality Management
• Software that allows you to improve quality,
  achieve compliance, lower risk, and reduce
  complaints by streamlining your quality
  management.
• Quick implementation easy to use
• Scalable to your needs as the business grows
• Seamless integration to enhance functionality
• Cloud-based approach that offers complete
  flexibility safety
• Offers low-cost implementation
• Available on cloud and on-premise
• Accessible for anywhere, at anytime and through
  any-device
• Personalized Dashboards for direct access to
  workflows

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Conclusion

• The pharmaceutical industry is highly regulated
  by the regulatory bodies such as FDA, ISO, etc.
  Hence, every pharma company should have
  efficient resources to ensure safe and quality
  products.
• Incorporation of a competent QMS for pharma
  industry like BM Quality Master provides a
  helping hand to pharma manufacturers to
  streamline their core operations and lead with a
  problem-solving approach.
• Get in touch with our team of experts today.

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