Certificate of Analysis

Definition:

A Certificate of Analysis (also known as CoA) is a document that attests to the quality and purity of a product. It is commonly used in pharmaceutical and chemical industries to ensure that batches manufactured meet established specifications.

The certificate of analysis contains important information such as:

• Proof of identity: Confirmation that the product is what it should be.
• Salary: The concentration of the main ingredients.
• Contaminants: Permissible limits for contaminants.
• Physical and chemical properties: Other relevant quality features.

These certificates are essential for quality assurance and are often required when approving products.

Test methods and standards
An analysis certificate also contains information on test methods used (e.g. in accordance with ISO, DIN or pharmacopoeic standards such as USP/EP) to ensure the traceability and comparability of the results. Standardised analysis methods and validation guidelines are used, which ensure that the tested specifications are reliable and internationally recognized.

_{Sources/further links:
USP (Certificate of Analysis & Analytical Methods Standard): USP Certificate of Pharmacopeial Analysis (On-Demand)}

_{European Pharmacopoeia — Reference Methods & Quality Standards: EDQM reference standards - FAQs Home - FAQs}

_{ISO 17025 (requirements for testing and calibration laboratories): https://www.iso.org/standard/66912.html}

_{DIN Standards Suite (Chemical Test Methods): Publications}

Traceability & batch control:
COAs support the full traceability of products along the supply chain and serve as proof in the event of complaints, quality checks or audits. They are often part of official documentation requirements and must be stored in an audit-proof manner. In regulated industries — such as pharmaceuticals and food — they are a central part of GMP and GDP processes.

_{Sources/further links:
EU GMP Guide, Part I — Documentation and audit requirements: Chapter 4 Documentation} 

_{EU GDP guidelines (documentation and traceability requirements): Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human UseText with EEA relevance} 

_{FDA — Lab Records & Certificate Requirements (§211.194): eCFR:: 21 CFR 211.194 -- Laboratory records.}

Challenge in managing certificates of analysis:

Decentralized and manual management of analysis certificates
Many companies still store and manage COAs in distributed systems or manually via email, Excel or paper-based archives. This results in media breaks, version conflicts and a high level of effort for traceability and audit security. Delays or errors in delivering COAs can slow down logistics and production processes.
_{Sources/further links:
McKinsey — Digital Quality in Chemicals (manual QC processes as an efficiency problem): Digitization, Automation, and Online Testing: The Future of Pharma Quality Control} 

_{FDA CFR §211.180 — Documentation and Retention Requirements: eCFR:: 21 CFR Part 211 -- Current Good Manufacturing Practice for Finished Pharmaceuticals}

Inconsistent COA formats make data processing difficult
COAs are often provided in various layouts, structures, and file formats in the supply chain. This lack of standardization makes automated import into ERP or QMS systems difficult, leads to manual testing costs and increases the risk of errors.
_{Sources/further links:
European Pharmacopoeia — standardized test methods and documentation: General Methods, General Chapters and General Monographs} 

_{ISPE — need for digital, structured quality data (Pharma 4.0): Guidance Documents | ISPE | International Society for Pharmaceutical Engineering} 

Time-critical dependency for approval processes
COAs are absolutely necessary before hazardous substances, pharmaceutical products or precursors can be processed, transported or passed on to customers. Delays or missing COAs lead to delivery stops, production downtime or inquiries along the supply chain.
_{Sources/further links:
EU GDP guidelines (documentation requirement before transport approval): Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human UseText with EEA relevance}

_{EU GMP Annex 15 — Batch Release & Test Documentation: EU-GMP-Leitfaden_Anhang_15.pdf}

Risk of compliance violations and recalls
Incomplete, faulty, or delayed COAs can cause legal issues, product suspensions, or recalls. Companies bear high liability risks in the event of quality fluctuations or lack of documentation.
_{Sources/further links:
EMA — Documentation requirements & traceability:}

_{‍Post-authorisation | European Medicines Agency (EMA)}

_{Improving quality of submissions | European Medicines Agency (EMA)}

_{FDA §211.194 — Quality test documentation (including COA obligations):}

_{eCFR:: 21 CFR 211.194 -- Laboratory records.}‍

Loady's solution:

Clear requirements for documents along the supply chain
Loady allows you to clearly define which documents — such as a certificate of analysis — are required for specific products and locations. Logistics and transport partners know in advance which documents are required and how they must be provided.

Central, consistent source of information
Product and location information is maintained at a central location and can be published in a controlled manner. This eliminates the need to manually forward requirements and distribute outdated requirements.

Standardised, multilingual data for international transport
Loady provides requirement information in a structured and multilingual manner so that drivers and logistics service providers receive consistent and verified information worldwide — regardless of location.

Data Sovereignty and Governance
Authorized roles (such as quality or location managers) maintain content directly. This ensures that data is accurate, up-to-date and comprehensible.