01
Step 01
Peptide Synthesis
SPPS or solution-phase synthesis with sequence verification and yield targets
QUALITY & REGULATORY FRAMEWORK
Quality Systems & Regulatory Infrastructure.
True Pharmaceutical operates within structured quality frameworks designed to support global regulatory expectations. We emphasize long-term supply integrity and reproducible manufacturing outcomes across every scale of production.
STERILE MANUFACTURING PROCESS
From Synthesis to Release.
A controlled, validated flow — every step documented, every environment classified, every batch released under QA oversight.
02
Step 02
Purification & Analytical Testing
HPLC purification, identity confirmation, purity assessment (>98%), impurity profiling
03
Step 03
Sterile Filtration (0.22µm)
Validated membrane filtration in controlled environment, pre-filter integrity testing required
Our Regulatory Approach
Process Validation Discipline
IQ, OQ, and PQ protocols for all critical manufacturing equipment and processes — ensuring reproducibility at every scale.
Batch Traceability
Complete material traceability from raw material CoA through finished product batch record — supporting regulatory submissions and audit readiness.
Analytical Method Oversight
Validated analytical methods per ICH Q2(R1). Routine method verification and OOS investigation protocols in place.
Documentation Control Systems
Structured document management with version control, review cycles, access management, and complete audit trails across all GMP documentation.
Controlled Change Management
Compliance & Certifications
Current certifications and active compliance programs.
cGMP Manufacturing
FDA-registered facilities, continuous compliance monitoring. ACTIVE
FDA Registration
Facility registered with U.S. Food & Drug Administration. ACTIVE
ICH Q7 Alignment
GMP for Active Pharmaceutical Ingredients. ACTIVE
ISO 9001 Quality Management
Quality management system certification. IN PROGRESS
Cleanroom Classification
ISO 5 (aseptic fill), ISO 7 (background), validated environments. VALIDATED
Aseptic Processing
Media fill validation, environmental monitoring program. VALIDATED
Download Our
Capabilities Overview.
A comprehensive summary of manufacturing capabilities, quality systems, regulatory certifications, formulation categories, and production specifications — formatted for print and regulatory review.