What is coa in pharmaceutical industry?

Chemical manufacturers and distributors must be able to demonstrate that the products they supply have met the requested specifications and passed all quality assurance tests.

A Certificate of Analysis (CoA) is a document that does exactly that – it summarizes all the tests performed on a product and gives the needed reassurance to the customers. It is therefore an essential document for most companies in the chemical and food sector.

A CoA is usually required whenever a customer needs to report to a regulatory agency or a government body. These typically include the Food and Drug Administration (FDA), the International Organization for Standardization (ISO) or The Occupational Safety and Health Administration (OSHA).

CoAs vary depending on the product, as each chemical is subject to different regulations. Moreover, a customized CoA has to be issued for every customer – even if they are purchasing the same product, their requirements or specification may vary.

If carried out manually, the process of filling a CoA is fairly time consuming and can be prone to errors. It’s also often difficult for suppliers and distributors to keep track of the various assurance tests that customers require.

While information going into a CoA may vary, there are certain tests commonly performed on chemical products. Examples of such tests include percentage of solid and pH, as well as percentage of moisture and viscosity.

Datacor’s enterprise resource planning (ERP) software makes everything far simpler. The CoA generated contains the following information:

Manual creation of CoAs complicates the process as it slows it down and increases the risk of inputting the wrong information by mistake. Other pain points could include the storing and sharing of certificates, as well tracking specific pieces of information in their text.

Companies that do not use a specialized ERP system traditionally rely on Microsoft Word templates to generate their CoAs.

However, the amount of customization involved in the creation of a separate CoA for each customer is too great and makes tracking each individual customer’s specifications too challenging.

Users that generate many CoAs, therefore, will need a much more dynamic tool to complete the task efficiently.

Datacor’s ERP is one of the few software solutions that can generate CoAs as it is specifically designed to meet the needs of the chemical manufacturing and distribution industry.

It allows users to keep records of the tests required by each customer and then quickly insert the results that validate those specifications.

There are three major features that distinguish Datacor’s ERP functionality from other software alternatives:

A Certificate of Analysis is a vitally important resource that prove products meet the required standards and are fit for purpose. Datacor ERP helps to simplify and optimize the entire CoA generation process.

How can an ERP system benefit my business?Enterprise Resource Planning helps to keep your business connected and automate everything from manufacturing and procurement to sales and logistics.

What are the main Features of Datacor’s ERP software for process manufacturing?Datacor ERP offers far more than certificate of analysis (COA) creation. Our software includes key features such as demand planning and forecasting, recipe and formula management, and master production scheduling (MPS).

How do I demo Datacor ERP?Want to learn more? Get in touch to request a free no-obligation demo of Datacor ERP.

General Requirements

Format of CoA

-The name and address of the laboratory issuing the CoA;

-The identification number of the CoA and on each page an identification, the page number and the total number of pages to ensure that every page is recognized as a part of the certificate;

-The name, address and contact person representing the originator of the request for analysis;

-The number assigned to the sample by the laboratory during registration upon receipt;

-The date on which the sample was received in the laboratory and the quantity of sample (number of units or packages);

-The name, description (for example, active ingredient, dosage form, strength, package size in the case of FPPs; grade in the case of starting materials; type and material of the primary packaging), batch number (used by the original manufacturer and repacker or trader) of the sample for which the certificate is issued, the expiry date (or retest date, where applicable) and date of manufacture (if available);

-The name and address of the original manufacturer; in addition, if supplied by repackers or traders, the certificate should show the name and address of the repacker or trader;

-Specifications for testing and a reference to the test procedure(s) used, including the acceptance criteria (limits);

-The results of all tests performed on the sample for which the certificate is issued (in numerical form, where applicable) and a comparison with the established acceptance criteria (limits); results of tests performed by subcontractors should be identified as such;

-Any comments, observations or information on specific test conditions, where these are necessary for the interpretation of the results;

-Conclusion as to whether or not the sample was found to be within the limits of the specification;

-The date and signature of the head of the laboratory or other authorized person approving the certificate.

Other Requirements

At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness.

There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are a few regulatory requirements which are often unknown.

A certificate of analysis is prepared for each batch of a substance or product and usually contains the following information:

(a) the registration number of the sample;

(b) date of receipt;

(c) the name and address of the laboratory testing the sample;

(d) the name and address of the originator of the request for analysis;

(e) the name, description and batch number of the sample where appropriate;

(f) the name and address of the original manufacturer and, if applicable, those of the repacker and/or trader;

(g) the reference to the specification used for testing the sample;

(h) the results of all tests performed (mean and standard deviation, if applicable) with the prescribed limits;

(i) a conclusion as to whether or not the sample was found to be within the limits of the specification;

(j) expiry date or retest date if applicable;

(k) date on which the test(s) was (were) completed; and

(l) the signature of the head of laboratory or other authorized person.

The analytical test report should provide the following information:

(a) the laboratory registration number of the sample;

(b) the laboratory test report number;

(c) the name and address of the laboratory testing the sample;

(d) the name and address of the originator of the request for analysis;

(e) the name, description and batch number of the sample, where appropriate;

(f) an introduction giving the background to and the purpose of the investigation;

(g) a reference to the specifications used for testing the sample or a detailed description of the procedures employed (sample for investigative testing), including the limits;

(h) the results of all the tests performed or the numerical results with the standard deviation of all the tests performed (if applicable); a discussion of the results obtained;

(j) a conclusion as to whether or not the sample(s) was (were) found to be within the limits of the specifications used, or for a sample for investigative testing, the substance(s) or ingredient(s) identified;

(k) the date on which the test(s) was (were) completed;

(l) the signature of the head of the laboratory or authorized person;

(m) the name and address of the original manufacturer and, if applicable, those of the repacker and/or trader;

(n) whether or not the sample(s) complies (comply) with the requirements;

(o) the date on which the sample was received;

(p) the expiry date or retest date, if applicable; and

(q) a statement indicating that the analytical test report, or any portion thereof, cannot be reproduced without the authorization of the laboratory.

At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness.

There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are a few regulatory requirements which are often unknown. Requirements can be found in the following sets of rules:

According to the EU GMP Guide Part I, certificates of analysis provide an overview of test results obtained from a product or a material. This also includes the assessment of compliance with the specification determined.

Section 11.4 of the EU GMP Guide Part II on certificates of analysis requires an authentic certificate of analysis for each batch of an intermediate or API. Among other things, this certificate should contain the following information:

A Certificate of Analysis (COA) is a document that communicates the results of a scientific test done on a product such as food or drugs. The COA also lists the chemicals used in the product's manufacturing and testing and is created to ensure all important regulations are met and complied with.