Quality & GMP Standards
Benchmarking against global best practices, we integrate uncompromising quality control into every stage of pharmaceutical manufacturing.
Our Commitment to Excellence
At PEC Pharma, customer satisfaction and patient safety are our primary objectives. We believe that true pharmaceutical excellence requires a proactive, systemic approach to quality assurance that exceeds basic regulatory compliance.
Our manufacturing infrastructure in GIDC Saykha, Gujarat, is equipped with a versatile multipurpose plant, managed by a team of qualified, experienced professionals. This infrastructure is underpinned by an advanced, fully-equipped quality-controlled laboratory (QC Lab).
Core Quality Pillars
GMP Manufacturing
Strict adherence to Good Manufacturing Practices ensuring consistent product safety, identity, strength, purity, and quality (SISPQ).
Advanced Analytics
In-house laboratories capable of complex spectroscopic and chromatographic analysis (HPLC, GC, NMR, LC-MS, IR) for robust validation.
Regulatory Compliance
Aligning with ICH compliance paradigms (including ICH Q3A/Q3B for impurities) and pharmacopoeial standards across 4 global export regions.
Comprehensive Documentation
Providing pristine Certificate of Analysis (CoA), batch manufacturing records (BMR), DMF/ACTD dossiers and complete traceability logs.
Quality Policy
To be a technology-based and market-driven pharmaceutical company that aims at innovative production and creates niche markets, complying with all high standard regulatory schedules for the domestic and international market. We achieve this through:
- Continuous Improvement: Regularly upgrading our quality management systems (QMS) and adopting the latest testing methodologies.
- Raw Material Control: Stringent vendor qualification and incoming material testing to ensure zero compromise at the source.
- In-Process Control (IPC): Rigorous monitoring during synthesis and formulation stages to prevent deviations.
- Training & Culture: Fostering a "quality-first" mindset across our workforce through regular GMP and safety training.
Analytical Capabilities
Our testing and validation ecosystem enables us to profile complex molecules, isolate impurities, and guarantee formulation stability. Our data packages include:
Frequently Asked Questions
What quality standards does PEC Pharma adhere to?
We manufacture our pharmaceutical products under strict Good Manufacturing Practice (GMP) standards. Our quality control and assurance team ensures compliance with applicable pharmacopoeial schedules, ICH Q3A/Q3B guidelines and global regulatory requirements.
Are your products supported by regulatory documentation?
Yes. Our APIs, intermediates and finished formulations are accompanied by comprehensive Certificate of Analysis (CoA) reports, batch documentation, spectroscopic data (NMR, HPLC/GC) and 50+ ready-to-file DMF and ACTD dossiers.
How does PEC Pharma handle batch traceability?
We maintain end-to-end traceability for all raw materials, intermediates and finished goods. Every batch dispatched is trackable back to the specific raw materials and production logs, ensuring accountability and safety.
Does your facility undergo independent auditing?
Yes. Our multipurpose manufacturing facility in Bharuch and our analytical laboratories undergo rigorous internal quality audits, client audits and regulatory inspections to ensure continuous compliance with quality benchmarks.