Batch Record

A controlled document that contains validated instructions on how to perform and document the manufacture of a product.


Corrective Action Preventative Action – This is a process for correcting and preventing errors during a procedure. A corrective action may be implemented as the result of a non conformance or deviation. The corrective action may be a document change, training, or any documented activity that is designed to stop the re-occurrence of the deviation. … Read more


Current Good Manufacturing Practice


Good Manufacturing Practice


Standard Operating Procedure The International Conference on Harmonization (ICH) defines a SOP as “detailed, written instructions to achieve uniformity of the performance of a specific function”.