OBJECTIVE : The purpose of this SOP is to lay down the procedure for ( Failure Investigation ) investigation failure of any activity to meet its predetermined specification, limits or acceptance criteria SCOPE : This SOP is applicable to process failures as well as non process failures (e.g. operator related). This SOP is not applicable […]
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OBJECTIVE: The purpose of this SOP is to lay down the procedure for men and material movement. SCOPE: This SOP is applicable for material movement across the different blocks and area and men movement in miscellaneous areas at the manufacturing facility. RESPONSIBILITY: Each individual entering into the area shall be responsible to follow the practice.
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1.0 OBJECTIVE To lay down the procedure for the visual inspection and statistical evaluation of a batch ( Acceptance Quality Level). SCOPE This procedure is applicable for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation, coating and packing in the company (XXX Name of the company).
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OBJECTIVE : The purpose of this SOP is to lay down the procedure for introduction of new product at the manufacturing location. SCOPE : This SOP is applicable for all new products including exhibit and validation batches being taken for manufacturing facility. Responsibility: Quality Control: Prepare and send the Specifications, Standard Test Procedures and Method
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OBJECTIVE: The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for operation of Neocota and Ganscoater used for tablet coating in coating area. SCOPE: This SOP is applicable to Neocota and Ganscoater used for tablet coating in coating area at manufacturing facility. RESPONSIBILITY: 3.1 Officer/ Executive shall be responsible
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for sampling of Rinse / Swab during manufacturing of different products. SCOPE: This SOP is applicable for sampling of Rinse / Swab during manufacturing of different types of products at manufacturing facility. RESPONSIBILITY: Authorized designee of QA shall prepare the
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OBJECTIVE: The purpose of this SOP is to provide a procedure for recording pressure difference in cubicle with respect to adjacent area. SCOPE: This SOP is applicable to checking of pressure difference in cubicles with respect to adjacent area at manufacturing facility. RESPONSIBILITY: Authorized designee of user department shall be responsible for recording of differential
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OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of different type of labels ( Label Control) in production department. SCOPE: This SOP is applicable for handling of different type of labelsat manufacturing facility. RESPONSIBILITY: Authorized designee of user department is responsible to maintain thestatus label in department. Head- user
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Purpose: This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the quality audit of marketed product and to evaluation of counterfeit/falsified medicines in the market Scope: This SOP is applicable to all marketed products with a view to evaluate their Performance under expected storage and operational conditions and to analyze
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OBJECTIVE: The purpose of this SOP is to lay down a procedure for Maintenance of Laboratory Instrument / Equipments in Quality control department. SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The Head of Quality Control Department or his
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