GMP Compliance with Sprint GMP
Good Manufacturing Practice (GMP) regulations ensure products are consistently produced and controlled according to quality standards. Sprint GMP provides the tools you need to meet GMP requirements across pharmaceutical, food, cosmetic, and medical device manufacturing.
What is GMP?
GMP regulations require manufacturers to establish and follow quality management systems. These systems must ensure that products are made consistently, meet quality standards, and are traceable from raw materials to finished products. Key requirements include documentation, batch records, quality control, and complaint handling.
How Sprint GMP Helps You Meet GMP Requirements
Complete Batch Traceability
GMP requires full traceability from raw materials to finished products. Sprint GMP automatically tracks every batch, linking raw material lots to production batches and finished products. You can instantly trace any product back to its source materials and forward to all batches that used it.
GMP Requirement: Maintain complete batch records showing all materials used, production steps, and quality control results.
Documented Procedures
All manufacturing procedures must be documented and version controlled. Sprint GMP stores your formulas, bills of materials, and standard operating procedures with full version history. Changes require approval workflows, ensuring procedures are reviewed before implementation.
GMP Requirement: Document all manufacturing procedures and maintain version control.
Quality Control Records
Quality testing must be documented for every batch. Sprint GMP provides structured test records that link to specific batches, store test results, and track approval status. All quality control data is searchable and ready for audit review.
GMP Requirement: Document all quality control testing and maintain test records for each batch.
Complaint Handling
GMP requires systematic complaint handling with investigation and corrective actions. Sprint GMP tracks complaints, links them to specific batches, documents investigations, and records corrective actions. The system maintains a complete audit trail of all complaint activities.
GMP Requirement: Establish procedures for handling complaints and investigating quality issues.
Audit Trail
Every change in your manufacturing system must be traceable. Sprint GMP automatically logs all changes to materials, batches, formulas, and quality records. The audit log shows who made changes, when they were made, and what changed, providing complete transparency for regulatory audits.
GMP Requirement: Maintain audit trails showing all changes to manufacturing records.
Document Management
GMP requires organized storage of certificates, test reports, and compliance documents. Sprint GMP provides centralized document storage with version control, expiration tracking, and easy retrieval. Link documents to materials, suppliers, or batches for instant access during audits.
GMP Requirement: Maintain organized records of all compliance documents and certificates.
Key GMP Features in Sprint GMP
- Complete batch-to-batch traceability with lot tracking
- Version-controlled formulas and procedures
- Structured quality control test records
- Complaint tracking and investigation workflows
- Complete audit trail of all system changes
- Centralized document management with expiration tracking
- Rapid recall capability for affected batches
Ready to Achieve GMP Compliance?
Sprint GMP provides all the tools you need to meet GMP requirements. Start your free trial today and see how easy compliance can be with the right system.
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