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: 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 …
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. …
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). …
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 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 …
SOP For Recording Pressure Difference in Manufacturing Area Read More »
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 …
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 …
