Products such as optical comparators are used to compare manufactured parts with perfect originals, and normal tolerances are far tighter than defined in the USP to ensure part to part consistency. EN 10204 Documentation Type Document Content Authorized By Type 2.1: Certificate of Compliance: Statement of compliance with order: Manufacturer: Type 2.2: Material: Statement of compliance with order and indication of results of non-specific inspection: Manufacturer: Type 3.1: 3. In addition to using certified and traceable measurement tools, more sophisticated equipment is employed to ensure that all parts meet very tight manufacturing tolerances. The COA exceeds the COC in that it is possible to know the exact measurements and therefore record those for individual test positions.īecause producing a COA is quite time consuming and involved, there is generally an additional charge for those.Īn example of a COA for a dissolution basket This happens when the material handler uses an independent third. This means that each part is separately measured and recorded by the manufacturer. Material with a Type 3.1 certificate can be validated to the intent of Type 3.2 certificates. The COC generally defines the tolerances that the accessories are manufactured to and these should fall within those defined by the USPĪll QLA dissolution accessories supplied by LabHut are supplied with a COC.Ī COA is far more stringent than a COC and records the actual physical measurements of each individual accessory or part. Thus all baskets, paddles, basket shafts, vessels and any other part of the system should be both defined and measurable within the tolerances specified.Īll dissolution accessories should conform to these specifications, and the certification that they do so is known as the COC or Certificate of Conformance. These specifications are generally physical and can be measured with the appropriate tools. This means that all dissolution testers and their accessories must meet the specifications defined in the monograph. What is the difference between COC and COA for Dissolution?įor dissolution testing, the guidelines are specified by the USP, EP and/or JP.
QLA Pure Quality Filters for Dissolution.In addition to the declaration of conformity with the requirements of the order and the chemical composition of. About Tablet Dissolution and Dissolution Testing Inspection certificate EN 10204:2005 3.1.