EXCiPACT Certification
What is EXCiPACT Certification ?
The EXCiPACT Certificate is an internationally recognized certification scheme developed specifically for pharmaceutical excipients. It certifies that excipient manufacturers and distributors comply with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), ensuring the quality, safety, and consistency of excipients used in pharmaceutical products. EXCiPACT helps reduce supply chain risks, enhances transparency, and builds trust between excipient suppliers and pharmaceutical companies by providing a globally accepted standard tailored to excipient production and distribution.
Benefits of getting EXCiPACT Certification ?
Getting a EXCiPACT Certification offers several benefits for businesses. Here are some potential advantages:
Global Recognition
EXCiPACT certification is accepted worldwide by pharmaceutical manufacturers, helping excipient suppliers gain international credibility and market access.
GMP & GDP Compliance Assurance
It confirms that excipient manufacturers follow Good Manufacturing Practices (GMP) and distributors follow Good Distribution Practices (GDP, ensuring consistent quality and safety.
Reduced Customer Audits
Since EXCiPACT is a trusted third-party certification, many pharmaceutical customers reduce or eliminate their own supplier audits.
Improved Product Quality & Safety
The certification enforces strong quality controls, risk management, and process consistency, reducing the chances of contamination or quality failures.
Enhanced Supply Chain Transparency
EXCiPACT ensures proper documentation, traceability, and change control throughout the excipient supply chain.
Increased Customer Trust
Certified organizations demonstrate their commitment to quality, which builds confidence among customers and regulators.
Regulatory Support & Compliance
Helps organizations meet regulatory expectations from authorities such as FDA, EMA, and other global regulators.
Competitive Market Advantage
EXCiPACT certification differentiates companies from non-certified suppliers, improving business opportunities and tender success.
Customer Trust & Loyalty
Shows commitment to responsible production, earning customer confidence.
Supports ESG & CSR Goals
Aligns with Environmental, Social, and Governance (ESG) standards and corporate social responsibility (CSR) strategies.
Audit Readiness
Prepares the organization for regular audits and assessments related to ESD controls.
Support for Digital Expansion
Contributes to India’s digital growth by helping establish a reliable and safe telecom network infrastructure with certified products.
For information on EXCiPACT Certification, please do not hesitate to reach out to us. We welcome the opportunity to discuss the process and requirements for becoming an esteemed partner.
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Who can get EXCiPACT Certification?
The ProTerra Certification contributes to India’s digital growth by helping establish a reliable and safe telecom network infrastructure with certified products. The following entities or businesses may seek approval from ProTerra Certification
Pharmaceutical excipient manufacturers
Excipient distributors and traders
Chemical companies supplying excipients to pharma industry
Contract manufacturers and processors
Warehousing and logistics service providers handling excipients
Domestic and international excipient suppliers
Leather Testing & Chemical Suppliers (as partners)
Document required for EXCiPACT Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of EXCiPACT Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain buyer approval in addition to enhanced performance.
The implementation process is described below:
Time Frame
Task
Process
Step 1
GAP Assessment
- GAP Assessment report as per EXCiPACT Certification checklist
Step 3
Training
- Training to Top Management
- Training to Employee's
Step 4
Implementation
- Verification of Documentation as per Checklist
- Internal Audit, Management Review Meeting & N-Closer for Internal Audit
Step 5
Audit Public Verification
- Verification by third party approval by EXCiPACT Certification
- Closer of Non-Conformetives
Year on Year
Yearly Compliance
- valid for three years
FAQ
EXCiPACT is an internationally recognized certification scheme for pharmaceutical excipients that verifies compliance with GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices).
No, it is not mandatory, but it is highly preferred by pharmaceutical companies and regulators worldwide.
EXCiPACT certificates are issued by approved, independent third-party certification bodies accredited under the EXCiPACT scheme.
The certificate is valid for 3 years, subject to annual surveillance audits.
GMP applies to excipient manufacturers, while GDP applies to excipient distributors and logistics providers.
No. EXCiPACT complements ISO standards and is specifically designed for pharmaceutical excipients.
Yes, it is globally recognized and accepted by major pharmaceutical manufacturers and regulatory bodies.
Typically, the certification process takes 2–4 months, depending on organization readiness and audit scope.
Yes, EXCiPACT is suitable for organizations of all sizes involved in excipient manufacturing or distribution.
Organizations must implement corrective actions, after which certification can be granted once compliance is verified.