What is the typical duration of a shelf life study?

Accelerated stability testing takes 6 months at 40°C/75% RH. Real-time stability testing requires minimum 12 months under proposed storage conditions, though many studies run 24-36 months to establish longer shelf lives. Total timeline from sample submission to final report is 7-40 months depending on claimed shelf life period.

Is shelf life study mandatory for all exports from India?

Yes, for regulated products including pharmaceuticals, FSSAI-regulated food items, and cosmetics. Non-regulated commodities (spices, tea, coffee without fortification claims) may not require formal studies but benefit from stability data for market credibility. Destination country regulations determine mandatory requirements—EU and USFDA markets always require validated shelf life documentation.

Can I use shelf life data from my international parent company?

Partially. If your facility manufactures under the same GMP conditions and uses identical formulations, you may reference parent company data as supporting documentation. However, CBIC and destination regulators typically require site-specific testing to validate that your manufacturing environment produces equivalent stability profiles. A bridging study (3-6 months comparative testing) is recommended.

What happens if my product fails the shelf life study?

If the product fails stability criteria, you must reformulate, change packaging, adjust storage conditions, or reduce the claimed shelf life. The laboratory will provide detailed failure analysis indicating which parameters degraded. Retesting after reformulation incurs additional laboratory fees (₹50,000–₹1,50,000). Failed products cannot be exported under the original claims until corrective action is validated through new testing.

How often must I renew my shelf life study certificate?

Shelf life certificates remain valid for 3-5 years from issuance. Renewal is mandatory when: formulation changes >5%, packaging changes, manufacturing location changes, destination regulations update, or product approaches claimed expiration without real-time confirmation. Proactive renewal 6 months before expiry prevents export delays and maintains CBIC compliance status.

Shelf Life Study

Expert guidance on Shelf Life Studies for Indian exporters. Ensure regulatory compliance for pharma, food, cosmetics. NABL-certified testing, DGFT-compliant documentation.

Select a NABL-accredited ISO/IEC 17025 certified testing laboratory capable of conducting stability studies for your product type
Submit product samples (20-30 units), master formulas, batch records, and proposed storage conditions to the chosen laboratory
Collaborate with the laboratory to develop a Stability Testing Protocol aligned with ICH Q1A(R2) or relevant pharmacopeial standards
Conduct parallel accelerated stability testing (6 months, 40°C/75% RH) and real-time testing under intended storage conditions (12-36 months minimum)
Receive Stability Test Report and Certificate with shelf life recommendation and analytical data for export documentation and customs declaration

Google VerifiedBusiness

500+Export Clients Served

End-to-EndEXIM Support

Book a Free Consultation Call

Share your details — our EXIM expert will call you back.

100% free, no obligation

We respond within 2 business hours

Dedicated expert for your service

What is Shelf Life Study?

A Shelf Life Study is a scientific evaluation conducted to determine the maximum period during which a product maintains its safety, efficacy, and quality when stored under specified conditions. For exporters in India, this study is essential documentation that validates product stability and extends marketability, particularly for pharmaceuticals, food products, cosmetics, and nutraceuticals destined for international markets. The study involves accelerated and real-time testing protocols that simulate storage conditions to predict product degradation rates and establish expiration dates compliant with importing country regulations.

Under the FSSAI Act, 2006 and Drugs and Cosmetics Act, 1940, shelf life determination is mandatory before product approval for export. The study generates scientific data demonstrating that the product remains safe and effective throughout its claimed shelf life, meeting both Indian regulatory requirements and destination market standards. This documentation becomes part of your export compliance record and is subject to verification by CBIC (Central Board of Indirect Taxes and Customs) during customs clearance.

Pricing

Package	Price	Details
Standard	On request	Including document prep

Process

📋
Select a NABL-accredited ISO/IEC 17025 certified testing laboratory capable of conducting stability studies for your product type
🔍
Submit product samples (20-30 units), master formulas, batch records, and proposed storage conditions to the chosen laboratory
📝
Collaborate with the laboratory to develop a Stability Testing Protocol aligned with ICH Q1A(R2) or relevant pharmacopeial standards
✅
Conduct parallel accelerated stability testing (6 months, 40°C/75% RH) and real-time testing under intended storage conditions (12-36 months minimum)
📤
Receive Stability Test Report and Certificate with shelf life recommendation and analytical data for export documentation and customs declaration

Documents Required

Valid IEC (Importer Exporter Code) from DGFT with active export status
Manufacturing License (Pharma: Form 20-B; Food: FSSAI Registration; Cosmetics: BIS/State License)
WHO-GMP or equivalent quality certification for pharmaceutical manufacturers
Product Master Formula and Batch Manufacturing Records with process parameters
Proposed packaging specifications and storage condition details (temperature, humidity, light exposure)
NABL-accredited Laboratory's Stability Testing Protocol and ISO/IEC 17025 accreditation certificate

Frequently Asked Questions

Related Services

By category

||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

Ready to get started?

Get a free consultation and custom quote.

Book Free Consultation

Shelf Life Study

Expert guidance on Shelf Life Studies for Indian exporters. Ensure regulatory compliance for pharma, food, cosmetics. NABL-certified testing, DGFT-compliant documentation.

Select a NABL-accredited ISO/IEC 17025 certified testing laboratory capable of conducting stability studies for your product type

Submit product samples (20-30 units), master formulas, batch records, and proposed storage conditions to the chosen laboratory

Collaborate with the laboratory to develop a Stability Testing Protocol aligned with ICH Q1A(R2) or relevant pharmacopeial standards

Conduct parallel accelerated stability testing (6 months, 40°C/75% RH) and real-time testing under intended storage conditions (12-36 months minimum)

Receive Stability Test Report and Certificate with shelf life recommendation and analytical data for export documentation and customs declaration

Google VerifiedBusiness

500+Export Clients Served

End-to-EndEXIM Support

What is Shelf Life Study?

Package

Price

Details

Standard

On request

Including document prep

Process

📋

Select a NABL-accredited ISO/IEC 17025 certified testing laboratory capable of conducting stability studies for your product type

🔍

Submit product samples (20-30 units), master formulas, batch records, and proposed storage conditions to the chosen laboratory

📝

Collaborate with the laboratory to develop a Stability Testing Protocol aligned with ICH Q1A(R2) or relevant pharmacopeial standards

✅

Conduct parallel accelerated stability testing (6 months, 40°C/75% RH) and real-time testing under intended storage conditions (12-36 months minimum)

📤

Receive Stability Test Report and Certificate with shelf life recommendation and analytical data for export documentation and customs declaration

Documents Required

Valid IEC (Importer Exporter Code) from DGFT with active export status

Manufacturing License (Pharma: Form 20-B; Food: FSSAI Registration; Cosmetics: BIS/State License)

WHO-GMP or equivalent quality certification for pharmaceutical manufacturers

Product Master Formula and Batch Manufacturing Records with process parameters

Proposed packaging specifications and storage condition details (temperature, humidity, light exposure)

NABL-accredited Laboratory's Stability Testing Protocol and ISO/IEC 17025 accreditation certificate