Explore how a next-generation, AI powered EQMS empowers compounded drugs businesses to maintain the required balance of artistry and science—customized care built on the foundation of quality and safety. It simplifies the complexities of end-to-end quality management through centralized processes, enhance traceability, and automate compliance with global standards like cGMP and ISO 9001. Explore the capabilities of Qualityze EQMS for Compounded Drugs today!
When it comes to compounded drugs, there is no room for error. Every dose, every formulation, and every process must meet the highest standards of quality, sterility, and regulatory compliance. [Your Company Name] is your trusted partner in transforming these challenges into opportunities for growth. With our integrated quality management platform, you can manage sterility risks, ensure robust documentation, and maintain compliance with applicable regulations. Experience a new era of efficiency, safety, and patient-centered care with solutions designed specifically for the complexities of compounding.
Leverage configurable workflows to ensure the accuracy and consistency of personalized formulations. Qualityze enables seamless documentation and monitoring of patient-specific compounds, minimizing the risk of errors in dosage and ingredients.
Streamline supplier qualification and ongoing assessments with Qualityze's Supplier Quality Management module. Monitor raw material quality and ensure compliance with pharmacopeial standards for every batch of compounded drugs.
Centralize and standardize batch record management with Qualityze's cloud-based solution. Effortlessly track ingredients, processes, and patient prescriptions while ensuring data integrity and traceability for audits and inspections.
Facilitate specialized training for compounding staff with integrated training management tools. Ensure continuous competency in handling sterile and hazardous drugs through role-based training plans and certification tracking.
Mitigate risks in handling hazardous drugs with workflows aligned to USP <800> standards. Qualityze ensures the implementation of advanced safety measures, including negative-pressure environments and PPE tracking.
Capture, analyze, and report adverse events seamlessly with Qualityze's centralized incident management module. Ensure rapid identification of patterns, effective root cause analysis, and regulatory compliance for adverse event reporting.
Standard/Regulation | Description |
---|---|
ISO Standards | |
ISO 9001 | General Quality Management System Requirements |
ISO 31000 | Risk Management Principles and Guidelines |
ISO 17025 | General Requirements for the Competence of Testing and Calibration Laboratories |
ISO 15189 | Quality and Competence in Medical Laboratories |
USP Standards | |
USP <795> | Pharmaceutical Compounding for Non-Sterile Preparations |
USP <797> | Pharmaceutical Compounding for Sterile Preparations |
USP <800> | Handling Hazardous Drugs in Healthcare Settings |
USP <825> | Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging |
FDA Regulations | |
21 CFR Part 11 | Electronic Records and Signatures |
21 CFR Part 210/211 | Current Good Manufacturing Practices (cGMP) for Finished Pharmaceuticals |
21 CFR Part 212 | cGMP for Positron Emission Tomography (PET) Drugs |
FDCA Section 503A | Pharmacy Compounding Requirements |
FDCA Section 503B | Outsourcing Facilities and Their Compliance Requirements |
GxP Guidelines | |
GMP | Good Manufacturing Practices: Ensuring Consistent Product Quality and Safety |
GCP | Good Compounding Practices: Best Practices in Pharmacy Compounding |
GDP | Good Distribution Practices: Maintaining Product Integrity in the Supply Chain |
Pharmacovigilance Standards | |
ICH E2E | Pharmacovigilance Planning |
WHO Guidelines | Safety Monitoring of Pharmaceutical Products |
EMA Good Pharmacovigilance Practices (GVP) | Standards for Monitoring Drug Safety |
Occupational Safety Standards | |
OSHA Hazard Communication Standard | For Handling Hazardous Chemicals |
NIOSH Guidelines | Safe Handling of Hazardous Drugs in Healthcare |
Environmental Standards | |
EPA Guidelines | Disposal of Pharmaceutical Waste |
DEA Regulations | Compliance for Controlled Substances in Compounding |
Industry-Specific Guidelines | |
ASHP Guidelines | Pharmacy Practice and Compounding Standards |
PCAB Accreditation Standards | For Pharmacies Engaged in Compounding |
NABP Model Pharmacy Act | Guidance for Compounding Pharmacy Operations |
Global Guidelines | |
WHO Technical Report Series | Guidelines on Compounding Practices |
PIC/S Guidelines | Harmonizing GMP Standards for Compounding Practices |
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