Certificate of analysis template is a document that is issued to a company by the Quality Assurance departments so as to confirm that the products of the company meet the required, tested criteria. The document contains the actual results that are derived from the tests performed as part of quality control of an individual batch of a product. Therefore, tests have to be done on your products and pass for you to receive a certificate of analysis.
Here are a particulars for certificate of analysis.
- Name and Address of the Certifying Body.
This is the first part o the certificate whereby all the details of the certifying company is indicated. The details include; the name of the organization and the physical address as well.
- The Title of Document.
The document should contain the correct title which reads “Certificate of Analysis.” Some companies may issue other names such as the certificate of compliance, but the collect title should be the certificate of analysis.
- Description of the Certified Reference Material.
This part contains all the information and description of the certified reference material. Enough information of the material should be identified so as to distinguish it from the other materials.
- Certified Reference Material Code and Batch Number.
Each and every certified material has its code and batch number which are different from the other certified reference materials.
- Description of Certified Reference Material.
The information described in this part includes the description about the batch number of the starting material or the raw materials used. It measures and finds out if the item is completely pure or there are any impurities detected. If there are any impurities found they should be recorded on this part.
- Intended use of Certified Reference Material.
This is the part where the reason for issuing the certified reference material is listed.
- Instructions for the CRM’s Correct Use.
The certificate of analysis should also include the safety data sheets. The reference material should be utilized according to the conditions given and in the sequence outlined in the document.
- Hazardous Situation.
The document should contain the material safety data sheet that lists the nature of any hazards and the precautions to take so as to avoid the dangers.
- The level of Homogeneity.
There is a section that consists of the data about the identity of the item.
The Certified Values and their Uncertainties.
In the case of any error in the budget, it should be recorded on the risk budget. All CRM should have a stated uncertainty that should be defined on the Certificate of Analysis.
The results of the measured property which can relate with stated reference should be indicated.
- Values Obtained by Individual Laboratories or Methods.
In the case where another lab is asked to check the results of the project carried out, the information should be reported on the certificate as well.
- Uncertified Values.
The values are listed to provide information and should be used as a reference.
- Data of Certification.
This is the part where the first dates of the certificate of reference material and the certificate of analysis are stated.
- Period of Validity.
The part indicates the date that the CRM’s and certificate of analysis are expected to expire.
- Further Information.
In the case where there is additional information to be added, it should be indicated as well.
- Names and Signatures of Certifying Officers.
The name of the official who takes responsibility for the information of the certified analysis must be included on the certificate.
Here are a few samples of the certificate of analysis.