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Your Trusted Generics Medicine Supplier
- +91 84484 44095 / 8071 555 357
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Mumbai, India
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Quality Standards & Manufacturing Excellence
Commitment to highest quality standards in manufacturing Mefloquine Tablets USP 250mg at Taj Pharma facilities.
Quality Policy
Our Commitment
Taj Pharmaceuticals is committed to manufacturing pharmaceutical products of the highest quality that consistently meet and exceed customer expectations and regulatory requirements. We strive for continuous improvement in our quality systems and processes.
Quality Objectives
- Maintain 100% compliance with WHO-GMP and international quality standards
- Achieve zero product recalls through rigorous quality control
- Continuously improve manufacturing processes and quality systems
- Ensure customer satisfaction through consistent product quality
- Maintain leadership position in pharmaceutical quality excellence
- Foster a culture of quality consciousness throughout the organization
Quality Principles
- Quality First: Quality is our top priority in all decisions and actions
- Compliance: Strict adherence to all regulatory requirements
- Continuous Improvement: Never satisfied with current performance
- Customer Focus: Understanding and exceeding customer expectations
- Employee Involvement: Every employee is responsible for quality
- Data-Driven Decisions: Quality decisions based on factual data
WHO-GMP Certification
WHO-GMP Certified Facilities
Our manufacturing facilities are certified by the World Health Organization - Good Manufacturing Practices (WHO-GMP), ensuring compliance with international quality standards for pharmaceutical production.
Key WHO-GMP Compliance Areas:
- Quality Management System: Comprehensive QMS covering all aspects of production
- Personnel & Training: Qualified personnel with ongoing training programs
- Buildings & Facilities: Designed and maintained for pharmaceutical production
- Equipment: Qualified, calibrated, and properly maintained equipment
- Documentation: Complete and accurate documentation systems
- Production: Validated processes and strict in-process controls
- Quality Control: Comprehensive testing and quality assurance procedures
- Contract Manufacturing: Proper oversight of contract manufacturers
- Complaints & Recalls: Effective systems for handling complaints and recalls
- Self-Inspection: Regular internal audits and self-inspections
Certification Scope
Our WHO-GMP certification covers:
- Manufacturing of solid dosage forms (tablets, capsules)
- Production of Mefloquine Tablets USP 250mg
- Quality control laboratory operations
- Packaging and labeling operations
- Warehousing and distribution
Certificate Validity: Valid through 2025 with regular surveillance audits
Quality Control Standards
Quality Control Systems
Raw Material Control
- Supplier qualification and approval
- Incoming material testing and verification
- Material specification compliance
- Stability testing of raw materials
- Traceability and batch tracking
In-Process Control
- Real-time monitoring of critical parameters
- Intermediate product testing
- Process validation and verification
- Environmental monitoring
- Equipment qualification and maintenance
Finished Product Testing
- Complete pharmacopeial testing
- Dissolution and content uniformity testing
- Microbiological testing
- Stability studies and shelf-life determination
- Batch release testing
Analytical Testing Methods
Chromatographic Analysis
- HPLC for assay and impurity profiling
- GC for residual solvent analysis
- TLC for rapid identification
Spectroscopic Analysis
- UV-Vis spectroscopy for assay
- IR spectroscopy for identification
- NMR for structure confirmation
Physical Testing
- Hardness, friability, and disintegration
- Particle size analysis
- Flow properties and bulk density
Stability Studies
Comprehensive Stability Program
Our stability studies ensure product quality throughout its shelf life under various storage conditions.
Long-Term Stability
- Duration: 36 months at 25°C/60% RH
- Real-time storage conditions
- Testing at 0, 3, 6, 9, 12, 18, 24, 36 months
- Parameters: Assay, dissolution, appearance, etc.
Accelerated Stability
- Duration: 6 months at 40°C/75% RH
- Predictive stability assessment
- Testing at 0, 1, 2, 3, 6 months
- Rapid identification of degradation pathways
Intermediate Stability
- Duration: 12 months at 30°C/65% RH
Refrigerated Stability
- Duration: 24 months at 5°C ± 3°C
- For products requiring cold storage
Stability Results for Mefloquine Tablets
Shelf Life: 36 months when stored below 30°C
Storage Conditions: Store in original container, protect from moisture and light
Stability Indicators:
- Assay remains within 95-105% of labeled amount
- Dissolution > 75% in 30 minutes throughout shelf life
- No significant degradation products detected
- Physical properties remain within specifications
Packaging Quality
Packaging Quality Standards
Our packaging systems ensure product protection, integrity, and compliance with regulatory requirements.
Primary Packaging
- Aluminum-Aluminum blister packs with high barrier properties
- PVC-Aluminum blister packs for cost-effective solutions
- HDPE bottles with child-resistant caps
- Tamper-evident seals and security features
Secondary Packaging
- Sturdy cartons with proper labeling
- Desiccant inclusion for moisture protection
- Batch and expiry date printing
- Product information inserts
Packaging Testing
- Integrity testing of blister packs
- Container closure integrity testing
- Label durability and legibility testing
- Transport simulation testing
Continuous Improvement
Quality Improvement Programs
Kaizen Events
Regular Kaizen events for process optimization and waste reduction
Six Sigma Projects
Six Sigma methodology for defect reduction and quality improvement
Lean Manufacturing
Lean principles for efficiency improvement and waste elimination
Quality Circles
Employee involvement in quality improvement initiatives
Quality Metrics & KPIs
Product Quality Index
Target: >99.5% | Current: 99.8%
Customer Complaint Rate
Target: <0.1% | Current: 0.05%
On-Time Delivery
Target: >98% | Current: 99.2%
First Pass Yield
Target: >95% | Current: 97.3%