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What Is a CEP (Certificate of Suitability)? A CEP (Certificate of Suitability) is an official document issued by the EDQM that certifies an active pharmaceutical ingredient (API) or excipient conforms to the quality standards outlined in the European Pharmacopoeia (Ph. Eur.). It replaces the need to submit detailed substance data in each EU Marketing Authorization […]
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What Is a Certificate of Analysis (COA)? A Certificate of Analysis (COA) is an official, batch-specific document issued by a manufacturer or quality control lab that verifies a product’s identity, strength, purity, and conformance to predefined specifications. It’s essential for quality assurance and regulatory compliance across APIs, excipients, drugs, and reference materials. Why Is a COA Important in the Pharma
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What is a Certificate of Origin(COO)? A Certificate of Origin (COO) is an official trade document that certifies the country where a product was manufactured, processed, or produced. In the pharmaceutical and chemical export industry, it serves as proof that goods originate from a particular country — a key requirement for customs authorities, trade agreements, and import licensing procedures. The document is
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What is a Certificate of Pharmaceutical Product (CPP)? A Certificate of Pharmaceutical Product (CPP) is an official document issued by a regulatory authority under the World Health Organization (WHO) Certification Scheme. It confirms that a specific pharmaceutical product is authorized for sale in the country of origin and complies with WHO Good Manufacturing Practice (GMP) standards. The CPP is one of the most recognized
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