Hello friends, I am here again with an exciting topic-certificate of analysis. Now you may be wondering that what on the earth is this certificate. Yes, I am fully aware that having this assumption that you all are ignorant about this certificate may be also not justified because if you run a pharmaceutical company, you may be fully aware of such certificate. Here, I will discuss how you can create such certificates with the certificate of analysis templates that I am going to provide you. Now, before you take a look at my certificate of analysis templates that I am providing without charging you a single penny, first you have to develop a clear understanding about the certificate itself.
What is a certificate of analysis
Certificate of analysis template is specifically used by a regulating and controlling agency of a government to be able to check if a pharmaceutical or any kind of product that is for organic consumption is safe for use or not. This document is also known as a COA (Certificate of Analysis) document. This document is used in many industries including the pharmaceutical, manufacturing, and food industry. In some cases, a COA includes a unique identification number.
What is COA in the medical field
You may be wondering that what significance can have a document like COA in the medical field. Pharmaceutical companies across the world have to show to the FDA that the materials that they have used for the drug preparation are safe for their intended consumption. Some examples of these materials are the raw ingredients, processing aids, etc. For the same, pharmaceutical quality control laboratories prepare and issue a certificate upon detailed testing and analysis (inspection) of the drug samples that they collect. This certificate is the COA or Certificate of Analysis in the medical field.
What is COA in the Food and Beverage Industry
We all know that the food and beverage industry is highly competitive. It is essential to control the production costs without compromising on the quality aspect. At the same time, companies within this industry are highly dependable on the testing and certification services of ISO/IEC 17205:2005 accredited labs to ensure they are providing only quality food products as expected by their customers. COA is the certificate that such a lab offers to a food company after picking up the food samples and testing them in a thorough manner for microbiological, nutritional, chemical, product development or other varieties of analysis. In the food and beverage industry, even a wrong choice of the packaging material can contaminate the manufactured or packaged food items. So, it is even checked that whether they have the right kind of primary packaging to reach the end customer or not.
What does COA mean in manufacturing
Just like the companies engaged in the food and beverage industry, those in the manufacturing industry too need a COA before exporting their manufactured products to other countries. For example, if you are a manufacturer of a cosmetic product say a talcum powder, you need to first prepare a COA where test results for the batch of talcum powder bottles that you want to export should be there with utmost clarity. In short, COA must have the batch number, production date, specifications, raw material used for manufacturing the same, expiry date, and other things that may be physical or chemical properties.
What are the components of a certificate of analysis
Following are the components of a certificate of analysis:
- Company Name/Identifier
- Product Name
- Catalog Number
- Lot Number
- Test Conditions
- Test Parameters
- Specifications or Requirements
- Results (qualitative and/or quantitative)
- Approval Signature and Date
Sometimes, some other essential information is also included within the document.
As if this is not enough…
I am going here to explain how you can get such a certificate. If you are a manufacturer of some food item that you want to export or to sale in your country of residence, you have to get the COA or otherwise, FDA will definitely shut down your business.
Now that you have already understood that to get this type of certificate, you have to give some samples of your manufactured items to quality control labs and they will issue the same to you. But before you provide the samples for testing and analysis, you have to keep in mind that you have adhered to all the preconditions that are outlined in the audit standards like that the audits of the Global Food Safety Initiative (GFSI), a global collaboration established by the International Trade Association.
There may be also some upfront costs associated with obtaining a certificate of analysis document. Especially if the results are not in your favor you may have to shell out more money for your action plan to ensure everything is falling in the right place.
Now if you have nothing to do with a manufacturing or pharmaceutical industry, a question is pop in your mind that how do I get a certificate of analysis? You can be also a customer like me. So, in such a case, ATTC, the global bio-resource center comes to your rescue. Just log on to http://www.attc.org and go to the tab ‘Resources’ in the menu. Now choose Certificate of Analysis (COA) under the section ‘Product Documents’. A new web page will open soon. You have to just enter the Lot number and the Catalog number of the packaged product in an input box and then just click on the ‘Retrieve Certificate of Analysis’ button. You can have a view of the same effortlessly!
Uses of a certificate of analysis template
I know that now that you have developed a concrete idea about the certificate of analysis, you must have an idea that certificate of analysis templates can be of great importance to you because such templates take away all the pain that goes into thinking what to put and what to not in the certificate. Also, even if you know the essential components that should be there in such a certificate, there remains a room for a lot of ambiguity about how all this information should be presented.
When you have readymade templates that you can edit, you are relieved. So, just browse through my beautiful certificate of analysis templates and choose the one that you think fits your purpose. Download it and edit or save it as per your requirements. Believe me, these templates can save your much valuable time. So, make the most of these templates and keep on checking my site for a range of templates.