February 25, 2019

GMP Requirements for Certificates of Analysis (CoA)

Quality Control

GMP Requirements for Certificates of Analysis (CoA) 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 […]

GMP Requirements for Certificates of Analysis (CoA) Read More »

General Safety Rules for  Quality Control Laboratory. 

Quality Control

General Safety Rules for  Quality Control Laboratory. General Safety Rules For Quality Control Laboratory. General and specific safety instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate (e.g. with written material, poster displays, audiovisual material and occasional seminars). General rules for safe working in accordance with national

General Safety Rules for  Quality Control Laboratory.  Read More »

Quality Control Testing of Raw Materials, APIs, and Finished Products.

Quality Control

Quality Control Testing of Raw Materials, APIs, and Finished Products. The Quality Control Testing  of Raw Materials, APIs, and Finished Products sample should be tested in accordance with the work plan of the laboratory after completion of the preliminary procedures. If this is not feasible the reasons should be noted, e.g. in the analytical worksheet,

Quality Control Testing of Raw Materials, APIs, and Finished Products. Read More »