OBJECTIVE To provide the guidelines for compilation of data for process parameters, assay values for actives to establish that Process performs according to design and is under control. Trend analysis data can be used to apply reduced testing in non-regulatory specifications after having established ...

OBJECTIVE The objective of carrying out Product Quality Review (PQR) is to establish that the product is manufactured as per approved procedures and the trends of results of critical quality attributes are well within acceptable limits. PQR will also address the review of raw and primary packaging materials ...

Manufacturers should ensure that the products are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures. Manufacturing processes should be shown to ...

BARBARA PIROLA: Hold time can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications What tools do pharmaceutical ...