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Pharmaceutical Quality Compliance (PQC) PDFDownload

Pharmaceutical companies are regularly subjected to tremendous financial pressure to produce products. A delay in releasing a batch of drug is not only costly but also consumes additional resources in the company. It is therefore crucial that analytical data be collected, compiled, and submitted in a timely, accurate and reliable but secure manner.

The PQC application is a centralized web based information management system for Pharmaceutical QC / QA to store batch analytical result, manufacturing information, and to track, monitors analytical/manufacturing data in a secure manner. The system supports the management of analytical result data of raw material, packaging material, water, finished product and stability of products.

The main functionality of PQC is to track a batch life cycle from manufacturing to batch release. The system enables the printing of reports like Certificate of Analysis (COA), trend analysis and other reports.

Good Manufacturing Practice
Benefits and Advantages
  • Enhance Productivity and Efficiency
  • Improve Reliability & Accuracy of QC Process
  • Faster Report Generation including APR
  • Comply with Regulatory Requirements
  • Centralized Analytical Information Repository
  • Faster Analysis of Analytical Data
  • Secured and Consistent Approval Process
  • Storage of QC, QA & Manufacturing Data
  • Patient Risk Reduction
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Modules
  • Product
    • Solid & Liquid Product
  • Raw Material (RM)
    • API & Excepients
  • Packaging Material (PM)
    • Primary & Secondary PM
  • Water
    • Boiler, Steel Mass, Purified, WFI, Tank, Feed, Softener etc
  • Stability
    • Development, Marketed & New Product
System Overview
System Diagram
Guidelines and Standards
  • GMP, EU GMP Annex 11, EU GMP Part 11, 21 CFR Part-11 and ICH guideline
    • Computerized System
    • Electronic Record, Data & Data Storage
    • Accuracy Check
    • Audit Trails
    • Change and Configuration Management
    • Security
    • Electronic Signature
    • Print outs
    • Batch Release
Batch Processing Steps
  • Batch Testing ( Test & Specification) by QC & MB
  • Batch Approval (Approve & Reject)
  • Product Authorization
  • COA for Every Step of a Batch
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Product Stability
  • Generate Schedule
  • Frequency Testing
  • Approval for Each Step
  • Authorization for Final Step
  • Storage Stability Result
Roles
  • Super Administrator
  • Administrator by Modules
  • Analyst (QC & MB) by Modules
  • Approver (QC & MB) by Modules
  • Authorizer (QC & MB) by Modules
  • Quality Assurance
  • Production
  • Data Entry Operator
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Stakeholders
  • Production
  • Quality Assurance (QA)
  • Quality Compliance (QC)
  • Validation
  • Stability
  • Raw Material (RM)
  • Packaging Material (PM)
  • Microbiology (MB)
  • Water
Features and Functionality
  • Master Data
    • Items (Product, Raw Material, Packaging Material, Water) Management
    • Specification Management for All Items
    • Shelf Life, Equipment and Others
    • Analyst, Approver & Authorizer
  • Batch Entry
  • QC & MB Analytical Result Entry & Approval
  • QA Observation Entry
  • Validation of Products
  • Authorization for Finished Products
  • Raw Material Audit
  • Email Notifications
  • Alert for Out of Specification
  • Certificate of Analysis (COA)
  • Automatic Stability Schedule Generation
  • Stability Analytical Data Entry and Approval
  • Printing Facility
  • Rich Searching Features / Advance Search
  • Browser Compatibility: IE6+, Firefox 3.5+
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Security
  • User Management
  • Active Directory Login
  • Roles & Privilege Management
  • Privilege for Edit & Update
  • Track Login & Logout
  • Audit Trail
  • Session Timeout
Reports
  • In House Reports by Modules, Departments & Steps
  • Basic Data Reports for Products (Manufacturing Data)
  • Certificate of Analysis (COA)
  • APR (Annual Product Review) for:
    • Analytical and Manufacturing Data
  • APR by Modules
    • Products
    • Raw Material
    • Packaging Material
    • Water
  • Graphical Reports of Trend Analysis
  • Analysis Time for QC, MB
  • Individual Specification by Items & Modules
  • QO Cycle Time & Yield Percentage for Product

Graphical Reports

APR: Trend Analysis for pH
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APR: Trend Analysis for Analysis Time
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APR: Trend Analysis for QO Cycle Time
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APR: Trend Analysis for Yield Percentage
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APR: Basic Data Report
Basic Data
Platform & Technology

ASP .NET 3.5 SP1, MS Chart, C#, CSS, JavaScript, IIS,SQL Server, JQuery, Ajax