1.0 PURPOSE: To lay down the Operation and Calibration procedure of Bursting Strength Test Apparatus. 2.0 SCOPE: SOP for Operation and Calibration of Bursting Strength Test Apparatus is applicable in Quality Control Department at (Company
1.0 PURPOSE: To lay down a procedure for Preparation, Review, Approval, Control and Revision of Site Master File. 2.0 SCOPE: This procedure is applicable for Preparation, Review, Approval, Control and Revision of Site Master File
1.0 PURPOSE: To lay down the procedure for operation and verification of Eye Washer and safety shower. 2.0 SCOPE: This procedure is applicable for the Operation of Eye Washer and safety shower in Quality Control
1.0 PURPOSE: To lay down the procedure for polishing of punches and dies. 2.0 SCOPE: SOP for polishing of punches and dies is applicable at production department of (Company name). 3.0 DEFINITIONS: NIL 4.0 RESPONSIBILITY:
1.0 PURPOSE: To lay down the procedure for inspection of uncoated tablets. 2.0 SCOPE: SOP for inspection of uncoated tablets is applicable at production department of (Company name). 3.0 DEFINITIONS: NIL 4.0 RESPONSIBILITY: 4.1 Production
1.0 PURPOSE: SOP for handling of deviation is to establish a system for identification, recording, evaluation and approval of any Deviations from the standard procedure. 2.0 SCOPE: This SOP for handling of deviation is applicable
1.0 PURPOSE: To lay down the procedure for usage and control of machine lubricants. 2.0 SCOPE: This procedure is applicable for usage and control of machine lubricant’s in OSD block at (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To lay down the procedure for operation and cleaning of LAF’s and RLAF’s. 2.0 SCOPE: SOP for operation and cleaning of LAF and RLAF is applicable both in injectable and OSD block at
1.0 PURPOSE: To lay down the procedure for operation and cleaning of dynamic pass box. 2.0 SCOPE: SOP for operation and cleaning of dynamic pass box is applicable for operation and cleaning of dynamic pass
1.0 PURPOSE: To lay down the procedure for manual defoiling of blisters and bottles. 2.0 SCOPE: The SOP for manual defoiling of blisters and bottles is applicable for manual defoiling of blister and bottles at
1.0 PURPOSE: To define the procedure for Re-packing of tablets and Capsules. 2.0 SCOPE: Procedure for Re-Packing is applicable for all products packed in Production Department of at (Company name). 3.0 DEFINITION: Not applicable. 4.0
1.0 PURPOSE: To describe the procedure for administration of Corrective and Preventive action (CAPA) , including tracking and reporting of the status of CAPA. 2.0 SCOPE: The SOP for corrective and preventive action (CAPA )
1.0 PURPOSE: To lay down a procedure for Hold Time Study of pharmaceutical products for various stages of manufacturing process. 2.0 SCOPE: The SOP for Hold Time Study of Pharmaceutical Products is applicable to the
1.0 PURPOSE: The SOP for self-inspection (Internal Audit) provides the procedure for self-inspection (Internal Audit) to verify compliance with cGMP. 2.0 SCOPE: This procedure applies to self-inspection (Internal Quality Audit) conducted by suitably experienced and trained personnel
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
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