OBJECTIVE: The purpose of this SOP is to lay down a procedure for reprocessing, reworking and recovery of the drug products. SCOPE: This SOP is applicable for handling of reprocessing, reworking and recovery of the drug products, at different stages of manufacturing, at the manufacturing facility. RESPONSIBILITY: Authorized Designee of Quality Assurance shall …
SOP For Handling of Reprocessing, Reworking and Recovery Read More »
OBJECTIVE To define the general requirements for an effective calibration control system to ensure that applicable measuring and test equipment is calibrated and maintained within accuracy limits sufficient for their intended purpose. SCOPE This procedure is applicable for calibration of all equipment /instrument/ measuring devices. RESPONSIBILITY Follow up: Concern Department Officer/Executive Overall responsibility: Concern …
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 …
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. …
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 …
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 …
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 …
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 …
OBJECTIVE: The purpose of this SOP is to lay down a procedure for Mobile phase filtration assembly in Quality control department. SCOPE: This SOP is applicable to Mobile phase filtration assembly in Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The Head of …
