| Preparation of Certificate of Analysis |
1.0 OBJECTIVE To lay down a procedure for preparation of certification of analysis. 2.0 SCOPE This SOP is applicable for preparation of Certificates of analysis in Quality Control Lab. 3.0 RESPONSIBILITY QC – Officer/ Sr. Officer /Executive/Sr. Executive and above. 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Preparation of certificates of analysis: 5.1.1 Formatting a test result is a ‘Certificates of Analysis’. 5.1.2 Quality control department officer / executive or his designee shall prepare certificate of analysis. 5.1.3 Certificate of analysis shall be prepared for various types of products and materials and water test results. 5.1.4 The test parameters in the COA shall be same as specification is applicable to those product/materials and water. 5.1.5 A typical formats of certificate of analysis for various type of products and materials and water shall be as given in the below table: 5.1.6 The product/ material and water information, and specification/ standard test procedure, date of sampling, date of analysis and other relevant details shall be given in the COA. 5.1.7 The test results in the COA shall have specific units with descriptive. 5.1.8 The standard statement for complies or does not comply shall be strike as appropriate. 5.1.9 Certificates of analysis shall be reviewed by Head QC or his designee and approved by Head QA or his designee in the COA format. 5.2 Certificates of analysis shall be filled along with record of analysis 6.0 ABBREVIATIONS SOP – Standard Operating Procedure QC – Quality control QA – Quality Assurance No. – Number COA – Certificate of analysis |
