Title: Quality Management System for Pharmaceutical Industry (1)
1Quality
Management System for Pharmaceutical Industry
2Agendai
- 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?
3About Pharmaceutical Industry
Industry that works in the matter of
researching, innovating, developing, and
manufacturing of drugs and medications to speed
up the treatment process.
4Typical Pharmaceutical Manufacturing Operations
Typical Pharmaceutical Manufacturing Operationst
Source- Report of Small Business Industry
Assistance (SBIA)
5Challenges 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
6Reasons 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
7What 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
8Importance 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
9What 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
10Core 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
11Features 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.
12Features 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.
13Features 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.
14Benefits 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
15Why 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
16Conclusion
- 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.
17About Us
Contact Us BatchMaster Software Pvt. Ltd. (An ISO
90012015 Certified Company) Brilliant Solitaire
Plot 6-A Office 201-A to 204-B Scheme 78,
Part-II, Indore - 452010 91-731-4008039 91-731-4
008070 91-731-4008035 contact_at_bmqualitymaster.com
BM QualityMaster is a product of BatchMaster
Software Pvt. Ltd. From last 20 plus years, we
are a leading business software development
company with noteworthy ERP, QMS, HRMS and other
technological products. we have offices around
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