1.0 PURPOSE: To lay down a procedure for introduction of any new product into the manufacturing facility with adequate assessment, in line with established system / procedure. 2.0 SCOPE: SOP for introduction of new product
1.0 PURPOSE: To lay down a procedure for Operation and cleaning of Friability test apparatus. 2.0 SCOPE: The SOP for operation and cleaning of Friability test apparatus covers the detailed procedures for operation and cleaning
1.0 PURPOSE: To lay down a procedure for Calibration of Friability test apparatus. 2.0 SCOPE: The SOP for Calibration of Friability Test Apparatus covers the Calibration of Friability test apparatus at Quality assurance, Quality control
1.0 PURPOSE: The purpose of this procedure is to provide guidelines for preparation, approval, issue of protocols and preparation and approval of reports. 2.0 SCOPE: The SOP for preparation of protocol and report is applicable to
1.0 PURPOSE: To lay down a procedure for identifying SS316 or SS 304 through molybdenum test kit. 2.0 SCOPE: This procedure applies to all the equipment’s or items for which the SS quality is to
Material of construction for the manufacturing equipment is a very crucial concern of GMP. Stainless Steel used in pharmaceuticals industry is an alloy of iron in which different materials are added. The main goal is
Current good manufacturing practice (cGMP) for finished pharmaceuticals falls under the schedule-M as per drug & cosmetic rule 1940 and refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. cGMP provides for
1.0 PURPOSE: To define the procedures of safety precaution in production area. 2.0 SCOPE: This SOP for safety precautions in production area is applicable to production department at (Company name). 3.0 DEFINITION: Not Applicable 4.0
1.0 PURPOSE: To define the procedures for performing lacto phenol cotton blue staining technique for identification of fungi. 2.0 SCOPE: This SOP for lacto phenol cotton blue staining for identification of fungi is applicable for
1.0 PURPOSE: To lay down a procedure for Laboratory safety guideline. 2.0 SCOPE: This procedure is applicable to all analysts who have work in Quality Control Laboratory at (Company name).
1.0 PURPOSE: To lay down a procedure for Disposal of all types of samples after testing excluding Microbiology. 2.0 SCOPE: This SOP for disposition of analytical samples covers Disposal of all types of samples after
1.0 PURPOSE: To lay down the procedure for cleaning of Sampling Tools. 2.0 SCOPE: This SOP for cleaning of sampling tools and accessories is applicable to all sampling tools (Rod, dies, scoops, spatula, etc.) used
1.0 PURPOSE:To lay down a procedure for preparation, review and approval of facility qualification document. 2.0 SCOPE:This procedure is applicable for preparation, review and approval of facility qualification at (Company name). 3.0 DEFINITIONS:Nil 4.0 RESPONSIBILITY:4.1