Pharmaceutical Manufacturing System
Pharmaceutical manufacturers require the highest level of GMP compliance, complete batch traceability, and rigorous quality documentation. Sprint GMP helps pharmaceutical companies meet FDA cGMP requirements and maintain the quality standards essential for patient safety.
Pharmaceutical Manufacturing Requirements
Pharmaceutical manufacturing is subject to FDA cGMP regulations, which require complete documentation of every aspect of production. Manufacturers must maintain detailed batch records, ingredient traceability, quality control testing, validation documentation, and complaint handling procedures. Pharmaceutical companies face rigorous FDA inspections and must demonstrate compliance at all times.
Sprint GMP for Pharmaceutical Manufacturers
Complete Batch Records
FDA cGMP requires complete batch production records documenting every step of pharmaceutical production. Sprint GMP automatically creates comprehensive batch records with full ingredient lot tracking, processing steps, equipment used, environmental conditions, and quality test results. Every batch is fully documented and ready for FDA inspection.
FDA cGMP Requirement: Maintain complete batch production and control records documenting all production steps and quality control activities.
Ingredient Traceability
Pharmaceutical manufacturers must track every active pharmaceutical ingredient and excipient from supplier receipt through production to finished product. Sprint GMP maintains complete lot-level traceability, so you can instantly identify which pharmaceutical batches contain specific ingredients. This is critical for recalls, quality investigations, and FDA inspections.
FDA Requirement: Maintain records to trace all ingredients used in pharmaceutical production, including active pharmaceutical ingredients and excipients.
Quality Control Testing
Pharmaceuticals require extensive quality control testing for identity, strength, purity, and quality. Sprint GMP provides structured test records that link to specific batches, store test results, track approval status, and ensure all required testing is documented before products are released. The system maintains complete test documentation for FDA review.
FDA Requirement: Test all incoming materials and finished pharmaceuticals for identity, strength, quality, and purity.
Validation Documentation
Pharmaceutical manufacturing requires validation of processes, equipment, and analytical methods. Sprint GMP's document management system stores validation protocols, reports, and supporting data. Link validation documents to specific processes, equipment, or test methods, and track validation expiration dates to ensure ongoing compliance.
Use Case: Store process validation reports, equipment qualification records, and analytical method validation documentation with expiration tracking.
Complaint and Adverse Event Tracking
Pharmaceutical companies must systematically handle customer complaints and adverse events, with mandatory FDA reporting requirements. Sprint GMP tracks complaints, links them to specific batches, documents investigations, and maintains records required for FDA MedWatch reporting. The system helps identify trends that may indicate product quality issues requiring regulatory action.
FDA Requirement: Establish procedures for complaint handling and adverse event reporting, with mandatory reporting for serious adverse events.
Rapid Recall Capability
When pharmaceutical quality issues occur, rapid recall is essential for patient safety. Sprint GMP's recall capability instantly identifies all batches affected by an ingredient or quality issue. You can quickly determine which products need to be recalled, notify FDA promptly, and provide complete batch documentation for recall effectiveness checks.
FDA Requirement: Maintain systems for rapid product recall, with complete batch documentation to support recall effectiveness.
Key Features for Pharmaceutical Manufacturers
- Complete batch production records with full ingredient lot tracking
- Complete ingredient traceability from supplier to finished product
- Quality control test records for identity, strength, purity, and quality
- Document management for validation protocols and reports
- Complaint and adverse event tracking with FDA reporting support
- Rapid recall capability for affected batches
- Complete audit trail of all system changes
- Supplier certificate management for API and excipient suppliers
Meet Pharmaceutical cGMP Requirements
Whether you're manufacturing prescription drugs, over-the-counter medications, or active pharmaceutical ingredients, Sprint GMP provides the traceability and documentation foundation for FDA cGMP compliance. Start your free trial to see how our system can help you meet the rigorous requirements of pharmaceutical manufacturing and protect patient safety.
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