Engineering Safety, Purity & Potency into Every Medicine
At Shikoy Pharma Pharmaceuticals Pvt. Ltd., Quality Control (QC) is not a mere compliance checkpoint—it is the foundational guarantee of our brand. Operating in strict accordance with WHO-GMP, GLP (Good Laboratory Practice), and ISO 9001:2015 standards, we ensure that every formulation distributed under our brand name is formulated at accredited partner units meeting rigorous clinical benchmarks.
Our accredited manufacturing partners and GLP testing facilities feature specialized Chemical, Instrumental, and Microbiological testing sections equipped with calibrated precision instruments to guarantee that every tablet, capsule, injection, and liquid preparation meets exact pharmacopoeial (IP/BP/USP) specifications before batch release.
Our 3-Tier Quality Control Workflow
Every formulation marketed by Shikoy Pharma passes through three uncompromising testing gates across accredited WHO-GMP partner units before reaching medical practitioners and patients.
Raw Material & API Analysis
Every consignment of Active Pharmaceutical Ingredients (APIs) and excipients is quarantined immediately upon arrival and sampled using statistical ANSI/ASQ Z1.4 protocols.
- FTIR Identification & Melting Point Verification
- HPLC Chromatographic Purity Assay (≥ 99.0%)
- Heavy Metals & Related Substances Limits
- Karl Fischer Moisture Titration & LOD
In-Process Quality Checks (IPQC)
Continuous, real-time hourly sampling across compression, encapsulation, liquid filling, and blister sealing lines to prevent process deviations.
- Tablet Hardness, Thickness & Weight Variation
- Tablet Friability testing (strictly < 0.8%)
- Disintegration Time (DT) profiling in 37°C media
- Fill volume & meniscus verification for liquids
Finished Batch Release Testing
No commercial batch leaves our warehouse without an authorized Certificate of Analysis (COA) signed by both the QC Manager and Head of Quality Assurance.
- Active Potency Assay via Reverse-Phase HPLC
- Complete In-Vitro Dissolution Rate (Q > 80%)
- Microbial Bioburden & Pathogen Absence Assay
- Leak Test & Blister Barrier Integrity Checks
Dedicated Testing Laboratories & Suites
Accredited partner manufacturing and testing facilities are segregated into distinct contamination-free zones with dedicated HVAC laminar flow units.
Analytical Chemistry Lab
Equipped with quaternary HPLC systems, dual-beam UV-Vis spectrophotometers, and digital polarimeters for molecular assay validation.
21 CFR Part 11 CompliantMicrobiology & Sterility Lab
Featuring Class 100 laminar airflow hoods, biological safety cabinets, microbial incubators, and bacterial endotoxin (LAL) test setups.
Zero Bioburden ValidationPackaging Testing Lab
Evaluates blister foil gauge, heat seal strength, vacuum leak testing, carton grammage, and optical barcode scannability.
Tropical Moisture BarrierControl Sample Archives
Temperature & humidity controlled retention sample banks maintaining reference quantities of every commercial batch for over 36 months.
Complete TraceabilityCertified Quality Credentials
Standardized Protocols & CAPA Quality Audits
Our Quality Assurance protocols enforce total cGMP compliance across all partner manufacturing lines through comprehensive batch documentation, Certificate of Analysis (COA) verification, and risk management systems.
Batch Manufacturing Records (BMR & BPR)
End-to-end documentation with real-time operator signoffs, line clearance checklists, and yield accounting.
Corrective & Preventive Actions (CAPA)
Structured root cause analysis (RCA) and systematic preventive actions for any out-of-specification (OOS) trends.
Stringent Vendor Qualification Audit
All API and primary packaging raw material suppliers undergo rigorous annual quality audits and compliance certifications.