Principle: The limit test for sulphate based on the interaction between soluble sulphate and barium chloride in the presence of dilute hydrochloric acid. This reaction produces barium sulphate, which manifests as solid particles (turbidity) within
Principle: The limit test for iron is based on the formation of the purple color through interaction of iron with thioglycolic acid within a solution buffered with ammonium citrate. This resultant produced is then compared
Limit test definition Limit: Threshold indicating presence or absence of substance in sample.Test: Qualitative or semi-quantitative analysis determining substance presence.Impurities: Undesirable substances present in material or chemical compound. “Limit test is defined as quantitative or
Definition of limit test: Limit test are quantitative or semi-quantitative tests designed to identify and control small quantities of impurity, which are like to be present in the substance. The quantity of any one impurity
The Significance of Limit Testing: Limit testing involves determining the maximum allowable concentration of a substance, beyond which it poses a risk to human health or the environment. For arsenic, establishing these limits is crucial
Data integrity stands as a paramount concern for regulators globally. It is due to poor practices develop by the industry. Collection of various types of information and results collectively called as data. This data are
1.0 PURPOSE: To lay down a procedure for Operation, Cleaning and Calibration of Ultra Violet Cabinet. 2.0 SCOPE: This SOP covers the procedure for Operation, Cleaning and Calibration of Ultra Violet Cabinet (Make- Aarkey Labtronix
1.0 PURPOSE: To define the procedure for cleaning of laboratory glassware used for analytical purpose, to avoid any cross contamination which results in erratic values. 2.0 SCOPE: The procedure for cleaning of laboratory glassware is
1.0 PURPOSE: To lay down the procedure for cleaning and sanitization of waste bins. 2.0 SCOPE: This procedure is applicable for cleaning and sanitization of waste bins in (Company name). 3.0 DEFINITIONS: Nil 4.0 RESPONSIBILITY:
1.0 PURPOSE: To define the procedure for total viable spore count determination of Biological indicator. 2.0 SCOPE: This procedure for total viable spore count determination of biological indicators is applicable to Quality Control Department, at
Quality Management System Definition: A Quality Management System (QMS) is a set of procedures, policies, plans, resources, processes, practices, specification of responsibilities and authority of an organization designed to achieve product and service quality levels,
1.0 PURPOSE: To define the procedure for operation and cleaning of cooling cabinet. 2.0 SCOPE: This procedure for operation and cleaning of cooling cabinet is applicable to warehouse department (Company name). 3.0 REFERENCE: Nil 4.0 DEFINITION: Cooling
1.0 PURPOSE: To define the procedure for handling and storage of raw and packaging materials. 2.0 SCOPE: This procedure for handling and storage of raw and packaging materials is applicable to warehouse department at (Company
1.0 PURPOSE: To define the procedure for operation and cleaning of vacuum cleaner. 2.0 SCOPE: This procedure for operation and cleaning of vacuum cleaner is applicable to warehouse/production department at (Company name). 3.0 REFERENCE: Nil
1.0 PURPOSE: To define the procedure for disposal of waste materials in warehouse. 2.0 SCOPE: This procedure for disposal of waste materials in warehouse is applicable to warehouse department at (Company name). 3.0 REFERENCE: NIL
1.0 PURPOSE: To define the procedure for safety and precautions in warehouse. 2.0 SCOPE: This procedure for safety and precautions in warehouse is applicable to warehouse department of (Company name). 3.0 REFERENCE: NIL 4.0 DEFINITION:
1.0 PURPOSE: To lay down the Procedure for Hydrostatic test for pipe lines. 2.0 SCOPE: This procedure applies for Hydrostatic test for all the MS, SS, PP and GI pipe lines (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To lay down the Procedure for Calibration of Dosing Pumps. 2.0 SCOPE: Procedure for Calibration of Dosing Pumps is applicable to all the Dosing Pumps related to the water plant at (Company name).
1.0 PURPOSE: To lay down the procedure for operation and cleaning of portable de-humidifier. 2.0 SCOPE: This procedure for operation and cleaning of portable de-humidifier is applicable at (Company name). 3.0 DEFINITIONS: De-humidification: Removing of
1.0 PURPOSE: To lay down the procedure for Operation and Calibration of Micropipettes. 2.0 SCOPE: This SOP is applicable for Operation and Calibration of Micropipettes used in Quality Control Department at (Company name). 3.0 REFERENCE:
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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