Quality Assurance

Uncompromising commitment to quality, safety, and efficacy in every product we manufacture.

Our Certifications Contact Quality Team

Our Quality Philosophy

Quality is not just a process - it's our commitment to excellence in every aspect of our operations.

Built-In Quality, Not Tested-In

At Spacegen Lifecare, we believe that quality cannot be tested into a product; it must be built into every step of the manufacturing process. Our quality assurance begins at raw material selection and continues through every stage of production, packaging, and distribution.

We maintain a culture of continuous improvement where every team member is empowered and responsible for quality. Our comprehensive Quality Management System ensures consistency, traceability, and compliance with global standards.

Our commitment extends beyond regulatory requirements to encompass ethical manufacturing practices, environmental responsibility, and sustainable operations that benefit both our customers and the communities we serve.

Quality Control Laboratory

Certifications & Accreditations

Our commitment to quality is validated by international certifications and regulatory approvals.

GMP Certified

Good Manufacturing Practice certification ensuring consistent production and control according to quality standards.

ISO 9001:2015

International quality management system certification for consistent quality and continuous improvement.

ISO 13485:2016

Medical devices quality management system certification for our diagnostic and medical product lines.

Organic Certification

Certification for our organic product lines, ensuring natural sourcing and processing standards.

NABL Accreditation

National Accreditation Board for Testing and Calibration Laboratories accreditation for our testing facilities.

WHO-GMP Compliance

World Health Organization Good Manufacturing Practices compliance for international market requirements.

Quality Assurance Processes

Comprehensive quality control at every stage of product development and manufacturing.

1

Raw Material Qualification

All raw materials undergo rigorous testing for identity, purity, potency, and contaminants before approval for use in manufacturing. We maintain a qualified supplier program with regular audits and performance reviews.

2

In-Process Quality Control

Continuous monitoring and testing during manufacturing ensures consistent product quality. Our in-process controls include physical, chemical, and microbiological testing at critical control points.

3

Finished Product Testing

Comprehensive testing of finished products against established specifications for identity, strength, quality, purity, and stability. Each batch undergoes multiple analytical tests before release.

4

Stability Studies

Long-term and accelerated stability studies determine shelf life and storage conditions for all products. We maintain stability chambers with controlled temperature and humidity conditions.

5

Documentation & Traceability

Complete batch records, testing documentation, and distribution records ensure full traceability. Our electronic document management system maintains records in compliance with regulatory requirements.

6

Continuous Improvement

Regular internal audits, customer feedback analysis, and process capability studies drive continuous improvement. We employ statistical process control and Six Sigma methodologies for quality enhancement.

Advanced Testing Methods

State-of-the-art analytical techniques for comprehensive quality assessment.

HPLC & UPLC

High-Performance and Ultra-Performance Liquid Chromatography for precise quantification of active ingredients and impurities.

GC-MS

Gas Chromatography-Mass Spectrometry for identification and quantification of volatile compounds and residual solvents.

Microbiological Testing

Comprehensive microbial limit testing, sterility testing, and preservative efficacy testing for product safety.

Physical Testing

Tablet hardness, disintegration, dissolution, and other physical tests to ensure product performance and consistency.

Endotoxin Testing

Bacterial endotoxin testing using LAL method for products requiring pyrogen-free specifications.

DNA-Based Authentication

Molecular authentication of herbal ingredients using DNA barcoding to ensure botanical identity and purity.

Quality Standards & Compliance

Adherence to national and international regulatory requirements.

Pharmacopoeial Standards

Compliance with USP, EP, IP, and other pharmacopoeial standards for all pharmaceutical products.

Nutraceutical Regulations

Adherence to FSSAI, FDA, and other regulatory requirements for dietary supplements and nutraceuticals.

Probiotic Standards

Compliance with international standards for probiotic identification, quantification, and stability.

Organic Certification

Adherence to NPOP, USDA, and EU organic standards for certified organic product lines.

Quality Performance Metrics

Measuring our commitment to quality through key performance indicators.

99.7%
Batch Release Rate
100%
Regulatory Compliance
0.02%
Customer Complaints
>99.5%
On-Time Delivery

Quality Assurance Inquiries

Contact our quality team for technical specifications, quality documents, or audit requests.

Quality Assurance Department

Our dedicated quality team is available to address your inquiries regarding product specifications, quality documents, regulatory compliance, and audit scheduling.

Quality Head

Ms. Deepika Patel

Quality Department

+91 9492591258

Email

quality@spacegenlifecare.com

Response Time

Within 24 hours for quality inquiries