Ever come across a solution for showcasing your food industry’s oversight of compliance with food safety and quality standards for every individual lot or batch of materials? This is exactly what a Certificate of Analysis (COA) provides.

What is a Certificate of Analysis (COA)?

A Certificate of Analysis (COA) is an official document generated by a laboratory outlining the outcomes of one or more laboratory tests. It may also include specifications and analytical methods, and it is signed by an authorized representative through manual or electronic means. The format and content of a COA may be structured based on the laboratory’s internal criteria, regulatory requirements, or standards established by relevant standard-setting bodies.

COAs have wide applications across various industries, including dietary supplements, pharmaceuticals, food items, and cosmetic products. Typically, they are issued by impartial third-party laboratories with specialization in testing and analysis. Customers, regulatory bodies, and other stakeholders often seek COAs as concrete evidence of a product’s quality and safety.

Purpose of a COA

The significance of COAs arises from their role in developing confidence that a product has undergone rigorous examination and scrutiny to confirm its quality and purity. They serve as a means of verification that the product adheres to corresponding designated parameters and is devoid of undesirable contaminants like heavy metals or harmful microorganisms. Furthermore, COAs are indispensable for validating the product’s compliance with federal and state regulations.

COA plays a multifaceted role beyond being a mere product inspection tool. With the continuous flow of materials between various locations, COA is capable of functioning as an essential document conveying detailed information from a material supplier to a material user. It is also possible for the receiver to compare the information provided in the vendor’s COA with their own specifications to determine whether the material aligns with the required criteria.

Components of a COA

The results in a COA must be delivered with precision, transparency, clarity, and objectivity, typically in the form of a report (such as a test report, calibration certificate, or sampling report). COA should encompass all the data that has been mutually agreed upon with the customer and is essential for comprehending the results. 

According to ISO/IEC 17025  guidelines for General Requirements for the Competence of Testing and Calibration Laboratories, the key constituents of COA can be understood as:

1. a title (e.g., “Test Report,” “Calibration Certificate,” or “Report of Sampling”);
2. the name and address of the laboratory;
3. the location of performance of the laboratory activities, including when performed at a customer facility or at sites away from the laboratory’s permanent facilities or in associated temporary or mobile facilities;
4. unique identification that all its components are recognized as a portion of a complete report and a clear identification of the end;
5. the name and contact information of the customer;
6. identification of the method used;
7. a description, unambiguous identification, and, when necessary, the condition of the item;
8. the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to the validity and application of the results;
9. the date(s) of performance of the laboratory activity;
10. the date of issue of the report;
11. reference to the sampling plan and sampling method used by the laboratory or other bodies where these are relevant to the validity or application of the results;
12. a statement to the effect that the results relate only to the items tested, calibrated, or sampled;
13. the results with, where appropriate, the units of measurement;
14. additions to, deviations, or exclusions from the method;
15. identification of the person(s) authorizing the report;
16. clear identification when results are from external providers.

Role of COA in Quality and Food Safety Control Process

A robust quality system will ensure that all inputs to the manufacturing process are reliable because quality controls will have been established for the receipt, production, storage, and use of all inputs. This is where COA becomes a key player in this process, as it is paramount in verifying the composition, quality, and safety of a specific raw material or ingredient utilized in these steps.

By referencing a COA, manufacturers can confirm that the incoming materials meet predetermined quality specifications and have undergone adequate testing and quality control measures, offering a systematic means to minimize the risk of using subpar or contaminated inputs, guaranteeing the overall quality and safety of the final product.

For instance, the BRC Global Standard for Food Safety specifies that a company shall have a procedure for the acceptance of raw materials and primary packaging on receipt based upon risk assessment. Acceptance of raw materials and their release for use shall be based on either one or a combination of product sampling and testing, visual inspection on receipt, certificates of analysis, and certificates of conformance, representing COA as a regulatory mandate for assessing ingredient risks. 

FDA’s Guidance for Industry on Quality Systems Approach to Pharmaceutical CGMP Regulations describes a comprehensive quality systems model, which, if implemented, will allow manufacturers to support and sustain proactive, modern quality systems that are consistent with CGMP regulations. This document entails COA as a non-negotiable ingredient in ensuring the safety and quality of the manufacturing process and produced products through the following points:

• CGMP regulations necessitate the use of either testing or a COA alongside an identity analysis to approve materials for manufacturing.

• The reliability of material safety and quality can be established by conducting tests or examinations and comparing the results with the supplier’s COA. Initial tests should be thorough enough for credibility and schedule for periodic reassessment.

• As part of purchasing controls, it is advisable to analyze data trends related to material acceptance and rejection based on records of COA to gauge supplier performance.

• The quality systems approach recommends periodic supplier audits based on risk assessment. These audits involve observing the supplier’s testing or examinations to assess the trustworthiness of their COA.

• A combined strategy is suggested, meaning that suppliers’ COAs should be verified through both analysis and supplier audits.

• Procedures should be implemented under the quality systems approach to verify the qualification of material sources and address the acceptance, usage, rejection, and disposition of materials produced in-house, as well as the systems responsible for producing them, all of which would involve COA generation to validate whether they meet their acceptance criteria. 

Steps Involved in COA Generation

A COA comes into existence as an end result of a multitude of processes. Let us delve into these steps:

1. Sample Collection: The process begins with the collection of samples from the batch of products to be tested. These samples should be representative of the entire batch.

2. Sample Identification: Each sample is labeled and identified with vital information such as batch or lot number, date of collection, and any other relevant identifiers.

3. Analytic Testing: The collected samples are sent to a qualified testing laboratory to perform the required analyses. The laboratory selects suitable testing methods based on the product’s specifications and requirements. The laboratory conducts a series of tests on the samples according to the selected methods.

4. Data Compilation: Test results are recorded, and data is compiled in an organized manner, including raw data and calculations used to determine the parameters being measured. 

5. Interpretation of Results: After obtaining the test results, the laboratory interprets the data to determine whether the product meets the specified quality and safety standards. They compare the results against established acceptance criteria and reference standards.

6. Report Creation: A formal COA report is generated. This report will include all the requisite elements.

7. Review & Approval: The COA report is reviewed and approved by qualified personnel within the laboratory. This individual ensures the report is correct, complete, and compliant, which is then published and maintained as a record of the product’s quality at the time of testing, which may become useful for traceability and future reference.

Challenges Associated with the COA Generation Process

The manual creation of COAs can be a cumbersome and error-prone process, complicating workflows and increasing the risk of inputting incorrect information. Moreover, issues arise in the storage and sharing of these certificates, as well as the daunting task of tracking specific details within their contents. For businesses that lack a specialized system, the conventional mode often involves using Microsoft Word templates to produce COAs. However, the extensive customization required to create distinct COAs for each customer presents a considerable challenge and hinders the efficient tracking of individual customer specifications. Some major challenges are:

Data Accuracy & Review

Ensuring the accuracy of the data presented in a COA is pivotal. Inaccuracies in this data can have significant consequences, including legal and regulatory issues, customer dissatisfaction, and product recalls. COAs bring up a snapshot of a supplier’s production process, detailing the characteristics of a shipment batch. When using traditional forms of COA generation, it provides static information, offering insights into a single point in time and failing to reflect ongoing compliance or potential variability. They are also difficult to review and manage, often getting lost or damaged, and can lead to delays in emergency situations. Sharing this information is also problematic, as multiple departments may need access to it. 

Compliance Status 

The compliance status of a product depends on the comparison and result between the product specifications, conducted analysis or test results, and the compliance outcome. When COA is created manually, this process becomes quite tedious and can lead to non-compliance issues in case any inconsistency occurs in the COAs, ultimately causing regulatory violations, non-compliance penalties, legal issues, or rejected shipments. Enabling manufacturers and stakeholders to assess the real-time compliance status of products would also be challenging.

COA Authentication

Authentication of the COA is about verifying the legitimacy of the document. In many industries, especially those dealing with high-value or sensitive products (e.g., pharmaceuticals), ensuring the COA has not been tampered with or forged is crucial. Proper authentication methods, such as digital signatures or secure storage, are essential to maintaining the integrity and trustworthiness of the COA.

COA authentication is instrumental in safeguarding consumer health and trust by ensuring the COA has not been tampered with or forged, thus facilitating transparency in the food supply chain.

Delivery Format

The format in which the COA is delivered can be a challenge. Different stakeholders, such as customers, regulatory bodies, or internal departments, may have specific requirements for how they receive and access COAs. Some may prefer hard copies, while others require electronic formats, like PDFs or integration with electronic record systems. Assuring that the COA is delivered in the apt format for each recipient can be a logistical challenge.

Digital Quality Management System (QMS) to the Rescue

A digital Quality Management System (QMS) integrates and harmonizes data across essential processes such as design control, document management, change management, non-conformance handling, complaint resolution, Corrective and Preventive Actions (CAPA), and audit management throughout the product lifecycle. A digital QMS can serve to eliminate the challenges linked to COA and support automated procedures to accelerate COA generation and achieve a faster quality management process through the following capabilities: