Quality Management System for Pharmaceutical Industry

1. Quality Management System for Pharmaceutical Industry

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

3. 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.

4. Typical Pharmaceutical Manufacturing Operations Typical Pharmaceutical Manufacturing Operationst Source- Report of Small Business & Industry Assistance (SBIA)

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

6. 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: Ø Contamination (Especially in batch production) Contamination (Especially in batch production) Ø Equipment failure due to delayed maintenance Equipment failure due to delayed maintenance Ø Inappropriate flow of data Inappropriate flow of data Ø Absence of written procedure Absence of written procedure Ø Imprecise formulation Imprecise formulation

7. 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: Ø Ensuring public’s safety Ensuring public’s safety Ø Preventing brand defamation Preventing brand defamation Ø Increasing product efficiency continually Increasing product efficiency continually Ø Helping to meet compliance standards Helping to meet compliance standards Ø Ensuring good clinical practice for trials Ensuring good clinical practice for trials

8. 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 Ø Lessens the risk of errors Lessens the risk of errors Ø Cuts costs by minimizing the waste Cuts costs by minimizing the waste Ø Keeps companies compliant Keeps companies compliant Ø Enhances customer satisfaction with high-quality Enhances customer satisfaction with high-quality products products Ø Helps maintain brand image by eliminating recalls Helps maintain brand image by eliminating recalls

9. 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, It checks all the critical stages of drug manufacturing, including: including: Formulation Formulation Method development Method development Facilities Facilities Utility system Utility system Equipment Equipment

10. 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. Ø Increasing Customer Focus Increasing Customer Focus Ø Efficient Resource Management Efficient Resource Management Ø Installing a Standard Processing Approach Installing a Standard Processing Approach Ø Maintaining Continuous Improvement Maintaining Continuous Improvement Ø Establishing Effective Communication Establishing Effective Communication Ø Risk Assessment Risk Assessment Ø Evidence-Based Decision Making Evidence-Based Decision Making

11. 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 - I Identify, document, investigate, and discard the non-conformities. investigate, and discard the non-conformities. dentify, document, CAPA - With this module, the users can With this module, the users can address underlying quality issues and execute address underlying quality issues and execute containment actions to prevent recurring. containment actions to prevent recurring. Complaint Management - Very important in today’s customer-oriented environment, this in today’s customer-oriented environment, this module of QMS can register, track, resolve, module of QMS can register, track, resolve, and close customers’ quality complaints. and close customers’ quality complaints. Very important

12. Features of a Pharma QMS Training Management - This capability of a QMS of a QMS upskills upskills the company’s staff by the company’s staff by automating training procedures and automating training procedures and fosters continuous improvement within fosters continuous improvement within the organization. the organization. This capability Change Management - From initiating change requests to evaluating, initiating change requests to evaluating, implementing, verifying, and closing, this implementing, verifying, and closing, this module helps manage every step of the module helps manage every step of the change control process. change control process. From Document Management - To manage the whole lifecycle of every document from the whole lifecycle of every document from creating, storing, tracking, retrieving, etc. creating, storing, tracking, retrieving, etc. this module is essential. this module is essential. To manage

13. Features of a Pharma QMS Compliance Management - To automate alerts for loopholes & potential issues to alerts for loopholes & potential issues to manage compliance, this module helps manage compliance, this module helps companies to stay compliant with the companies to stay compliant with the stringent SOX, FDA, and ISO guidelines. stringent SOX, FDA, and ISO guidelines. To automate Risk Management - Crucial to all business, Crucial to all business, this module identifies, categorizes, and this module identifies, categorizes, and assesses risks proficiently, and helps eliminate assesses risks proficiently, and helps eliminate it permanently. it permanently. Audit Management - To provide insightful business data to automate & insightful business data to automate & streamline the process of audits. streamline the process of audits. To provide

14. Benefits That a “QMS for Pharmaceutical” Provides Ø Promotes effective and faster execution Promotes effective and faster execution of processes of processes– adhering to the CGMP adhering to the CGMP norms norms Ø Increases customer satisfaction with Increases customer satisfaction with precise manufacturing precise manufacturing Ø Elevates brand value by adhering to Elevates brand value by adhering to safety standards safety standards Ø End-to-end traceability to reduce End-to-end traceability to reduce waste and speed recalls waste and speed recalls Ø Increases efficiency by improving Increases efficiency by improving supply chain performance supply chain performance Ø Enhances safety by reducing risks Enhances safety by reducing risks

15. 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. Ø Quick implementation & easy to use Quick implementation & easy to use Ø Scalable to your needs as the business grows Scalable to your needs as the business grows Ø Seamless integration to enhance functionality Seamless integration to enhance functionality Ø Cloud-based approach that offers complete flexibility & safety Cloud-based approach that offers complete flexibility & safety Ø Offers low-cost implementation Offers low-cost implementation Ø Available on cloud and on-premise Available on cloud and on-premise Ø Accessible for anywhere, at anytime and through any-device Accessible for anywhere, at anytime and through any-device Ø Personalized Dashboards for direct access to workflows Personalized Dashboards for direct access to workflows

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

17.      About Us Contact Us 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 the globe to serve customers from all geographies and industries. BatchMaster Software Pvt. Ltd. (An ISO 9001:2015 Certified Company) Brilliant Solitaire Plot 6-A Office 201-A to 204-B Scheme 78, Part-II, Indore - 452010 For more details visit: +91-731-4008039 +91-731-4008070 +91-731-4008035 https://www.batchmaster.co.in/ contact@bmqualitymaster.com