Streamline Compliance and Navigate Regulatory Audits with Success
Streamline Compliance and Navigate Regulatory Audits with Success
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Managed Quality Systems
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Best Practices...
Recommendations
We strongly advise reviewing the output thoroughly for accuracy and comprehensiveness before sharing it further. Your diligence ensures the reliability and completeness of the information. It also ensures that your response to any regulatory observations is valid.
Annual Product Quality Reports
Recommendations:
Please add your (specific) details, such as: Industry, Previous Product Quality Review(s), Product types, equipment list, product specifications, location/site, etc. (scroll down to the platform)
For Best Results
Use the following sample list and provide as much information as possible (Product Quality Review).
- Completed product quality reports(s)
- Inspection(s), observations, and results
- CAPA (short-term, long-term solutions) - results
- Analytical test results
- Stability data
- Specifications (API, DP)
- Deviation reports (product specific + other relevant - same production line)
- Change control records
- Complaint logs
- Recall information (if any)
- Certificates of Analysis
- Customer complaints
- Other...
Disclaimer!
Before proceeding with your assessment we encourage you to read - Disclaimer! given below...
Disclaimer! Attention required!
Kindly take note...
The AI platform undergoes continuous training to remain up-to-date with the latest regulatory developments and to align with Quality Management Systems (ISO 9001) as well as current Good Manufacturing Practice (cGMP) guidelines. The accuracy and reliability of the results generated depend significantly on the quality and integrity of your data, as well as the manner in which you interact with the system. For optimal performance and alignment with your goals, we strongly recommend having your data and the system's outputs reviewed by internal experts, subject matter specialists, or professional consultants. While we strive to provide a valuable tool, we offer no guarantees regarding specific outcomes and assume no responsibility for any results stemming from the use of this system, its outputs, or information presented on our website.
High Quality Output
APQR report summarizes key findings of the annual review
Open Your Sky
By pressing the High-Speed Rotation button on remote, the drone will spin automatically at certain height. No need to hold the direction throttle all the time now.
By pressing the High-Speed Rotation button on remote, the drone will spin automatically at certain height. No need to hold the direction throttle all the time now.
By pressing the High-Speed Rotation button on remote, the drone will spin automatically at certain height. No need to hold the direction throttle all the time now.
FIRST LIGHT EDITION
The Ultimate WHO Inspection Guide
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Step-by-Step Expert Guidance
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Regulatory Compliance
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*Available with subscription only. Conditions apply!
Regular price $2499 with 24/7 virtual consultant or Workbook template pack...
Ethical Use of AI Technologies
Continuous Improvement & Commitment to Quality...
We are dedicated to fostering responsible use of AI-driven methodologies and learning. Confidentiality of customer property is our top priority.
Responsible Use of AI Technologies
We continuously optimize and enhance our processes and use the most advanced versions of AI models for accuracy and reliability of our platform. Data processed via AI models is strictly handled in accordance with respective policies of the major AI providers and processed in highly secured environments. For any question, use our contact form.
We choose, design, and train our system utilizing the most advanced AI methodologies to create value for the end user. We aim to create significant value for our clients by producing detailed comprehensive quality reports that cater specifically to the manufacturing sector.
We understand the unique challenges faced by quality professionals in various manufacturing domains and deliver tailored solutions to meet those needs.
Our processes are designed to maintain utmost transparency and accountability.
We provide clear insights into the capabilities, potential limitations of our platform, and risks associated with our quality assessments, enabling informed decision-making.
Our services are designed to be accessible to companies of all sizes, ensuring even smaller manufacturers can achieve high compliance and quality levels.
Our reports include detailed explanations and follow-up recommendations to ensure clarity and actionable insights.
Clients are fully informed about our data handling practices, and access to our services is granted only after agreement to our Privacy Policy.
We retain personal and client information only as necessary for the fulfillment of the purposes specified, ensuring data is handled responsibly. Customers are able to delete any of the user-input records at the end of each session.
We continuously optimize our processes to enhance the accuracy and reliability of our quality reports, minimizing inconsistencies and ensuring dependable outcomes.
Case Studies
Data driven quality prediction and reporting...
AI-Driven Trend Analysis for a Generic Pharmaceutical Company
Company Profile:
- Company: XYZ Pharma
- Product: XYZ Calcium Tablets (10 mg, 20 mg, 40 mg)
- Dosage Form: Tablets
- Annual Production Volume: 200 million tablets
- Region: XYZ
- Review Period: January 2022 – December 2022
Challenge:
- The company struggled with identifying subtle trends in critical quality attributes (CQAs) related to dissolution rates and impurity levels from batch-to-batch data. Manual APQR preparation was
- time-intensive, error-prone, and often delayed, which led to regulatory observations during a recent regulatory inspection.
AI Application:
- AI Integration: A machine learning algorithm was deployed to analyze manufacturing, laboratory, and stability data across batches.
- Data Collection: The AI system utilized data pulled from the company’s ERP, LIMS, and MES systems.
- Predictive Insights: The AI flagged patterns in slight dissolution rate variations, correlating them with specific raw material batches.
Company Profile: BioX Solutions
Product: Multiple Injectable Products
Annual Production: 50 million units
AI Implementation in APQR:
- Multi-product trend analysis
- Environmental monitoring data integration
- Automated deviation classification
- Risk pattern identification
Measurable Outcomes:
I. Process Optimization:
- 60% reduction in deviation investigation time
- Identification of cross-product quality patterns
- Proactive contamination control measures
II. Regulatory Compliance:
- Enhanced sterility assurance documentation
- Automated compliance checking with global regulations
- Real-time alert system for critical parameters
III. Cost Savings:
- Annual savings in quality-related costs
- 45% reduction in laboratory investigations
- Decreased product hold times
Bite-Sized Learning
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The Quality Department should not be directly involved in the day-to-day operation of the manufacturing line. For instance, a Quality Control analyst shouldn't be simultaneously running the manufacturing equipment and then testing the product they just produced.
The Quality Department's role is to verify that the manufacturing process is consistently producing a product that meets the required quality standards.
This independence is crucial to prevent potential conflicts of interest. If the
same person is responsible for both production and quality control, there's a risk that they might be tempted to overlook deviations or manipulate data to meet production targets.
Tips to be useful for professionals conducting or preparing for pharmaceutical inspections.
- Verify that the Quality Department operates independently from Production to maintain objectivity.
- Review organizational charts and job descriptions to confirm this separation.
- During inspections, ask for records that demonstrate independent oversight of manufacturing processes, such as quality audits or deviation investigations led by the Quality team.
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