“Uncompromising Testing for Superior Product Safety & Efficacy”
At Oceanic Pharmachem, we recognize that delivering high-quality pharmaceutical products requires rigorous testing, precise analysis, and strict compliance with global regulatory standards. Our Quality Control (QC) Department ensures that every batch meets the highest industry benchmarks by performing in-depth analytical testing, documentation verification, and risk assessments before product release.
We adhere to stringent cGMP (Current Good Manufacturing Practices), ICH Guidelines, and global pharmacopeial standards (USP, EP, JP, IP, BP), ensuring that every product is safe, effective, and market-ready.
Advanced Quality Control Processes
Our Quality Control system is built on a multi-layered approach that involves:
1. Pre-Shipment Sampling & Testing
Before dispatching any product, we implement a strict three-tiered sampling process:
This system ensures total transparency, batch-to-batch consistency, and full product traceability.
2. Comprehensive third Party Analytical Testing
We conduct extensive testing to verify purity, potency, stability, and safety of every product. Our core analyses include:
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Purity & Impurity Profiling |
? Detection and quantification of related substances ? Organic volatile impurity analysis ? Heavy metal contamination checks |
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Residual Solvent Testing |
? Ensures solvents are within permissible limits as per ICH Q3C guidelines |
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Microbiological & Endotoxin Testing |
? Identification of bacterial contamination ? Sterility and endotoxin level assessment for injectable products |
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Physical & Chemical Property Testing |
? pH, moisture content, and density measurement ? Particle size distribution and polymorphic form analysis |
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Stability & Shelf-Life Testing |
? Accelerated Stability Testing (ICH Q1A guidelines) to predict product shelf life ? Real-time Stability Studies under varied environmental conditions |
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Dissolution & Content Uniformity Testing |
? Ensuring proper drug release profiles for pharmaceutical formulations |
By covering every critical parameter, we guarantee that our products meet the highest safety and efficacy standards before reaching the market.
3. Cutting-Edge Analytical Instruments
We have excellent third party testing laboratories with state-of-the-art laboratory equipment for precise and reproducible results:
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High-Performance Liquid Chromatography (HPLC) |
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Gas Chromatography-Mass Spectrometry (GC-MS) |
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Nuclear Magnetic Resonance (NMR) |
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Fourier Transform Infrared Spectroscopy (FTIR) |
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X-Ray Diffraction (XRD) |
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Inductively Coupled Plasma (ICP) for Heavy Metal Analysis |
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Microbial Contamination & Sterility Testing Chambers |
This highly advanced setup allows us to detect even trace-level impurities, ensuring that every batch conforms to the strictest global quality norms.
4. Data Integrity & Documentation
Our custom syntheisis partner maintain detailed, audit-ready documentation to ensure transparency, regulatory compliance, and full product traceability. Our QC documentation includes:
? Certificate of Analysis (COA) – Comprehensive quality assessment of each batch
? Batch Manufacturing Records (BMR) – Documented proof of adherence to quality guidelines
? Regulatory Compliance Reports – Ensuring alignment with international standards
? Transportation & Storage Records – Complete traceability for every shipment
Our partner follow the ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) principle for data integrity, ensuring that all records are tamper-proof, well-documented, and regulatory-compliant.
5. Regulatory Compliance & Audits
Our Custom synthesis partner ensure strict compliance with international quality and safety regulations, including:
USFDA, MHRA, EMA, WHO-GMP, EDQM, TGA, and ANVISA standards
ICH Q6A/Q6B Guidelines for Specifications
ISO 9001 & ISO 17025 Laboratory Accreditation
And the dedicated QC experts conduct regular internal audits, supplier audits, and third-party verifications to ensure seamless regulatory compliance.
With Oceanic Pharmachem, you can be confident that every product has passed stringent quality checks, thorough testing, and regulatory audits — ensuring safety, consistency, and market readiness.
Partner with us for Uncompromising Quality Control – Contact Oceanic Pharmachem Today!