Quality Assurance

SOP For Handling of Reprocessing, Reworking and Recovery

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 …

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SOP For Calibration

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 …

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SOP for Handling of Artwork

OBJECTIVE: The objective of this SOP is to lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork. SCOPE:  This SOP is applicable for preparation, approval, distribution, revision, retrieval and destruction of artwork at the manufacturing facility. RESPONSIBILITY: Marketing: Responsible for Color and Design Production Department: Responsible for mentioning size as …

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SOP For Acceptance Quality Level

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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SOP For Sampling of Swab/Rinse

 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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SOP For Recording Pressure Difference in Manufacturing Area

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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SOP For Label Control

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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