SOP FOR OPERATION AND CLEANING OF DUST EXTRACTOR DRY SYRUP FILLING MACHINE

SOP FOR OPERATION AND CLEANING OF DUST EXTRACTOR DRY SYRUP FILLING MACHINE OBJECTIVE: To lay down the procedure for cleaning and operation of Dust Extractor Machine in Dry Syrup Filling. SCOPE: This procedure is applicable to Dust Extractor Machine in Dry Syrup Filling area. RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the … Read more

SOP FOR OPERATION AND CLEANING AIR JET CLEANING MACHINE

SOP FOR OPERATION AND CLEANING AIR JET CLEANING MACHINE OBJECTIVE: To lay down a procedure for the operation and cleaning of Air Jet cleaning machine. SCOPE: This procedure is applicable for operation and cleaning of Air Jet cleaning machine placed in Dry Syrup area. RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure … Read more

SOP FOR OPERATION AND CLEANING OF TURN TABLE

SOP FOR OPERATION AND CLEANING OF TURN TABLE OBJECTIVE: To lay down the procedure for operation and cleaning of turn table. SCOPE: This procedure is applicable for operation and cleaning of turn table. RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP. Officer Production/Supervisor or designee is … Read more

SOP FOR PERSONNEL ENTRY AND EXIT PROCEDURE IN PRODUCTION

SOP FOR PERSONNEL ENTRY AND EXIT PROCEDURE IN PRODUCTION OBJECTIVE: To lay down the Procedure for Entry and Exit Procedure for Staff, Visitors, worker in Secondary Change Room of Production Area. SCOPE: This procedure is applicable for Entry and Exit procedure for Staff, Visitors, worker. RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the … Read more

SOP FOR PROCEDURE FOR ENTRY AND EXIT TO THE WAREHOUSE

SOP FOR PROCEDURE FOR ENTRY AND EXIT TO THE WAREHOUSE OBJECTIVE: To lay down the procedure for entry and exit to the warehouse. SCOPE: This procedure is applicable to Opening and closing of warehouse RESPONSIBILITIES: It is the responsibility of store assistant to follow the procedure as prescribed in this SOP during entry and exit to the warehouse. … Read more

SOP FOR MANUFACTURING OPERATION START UP AND SHUT DOWN IN THE AREA

SOP FOR MANUFACTURING OPERATION START UP AND SHUT DOWN IN THE AREA OBJECTIVE: To lay down the procedure for Manufacturing Operation start up and close down the activity. SCOPE: This procedure is applicable for activities to be carried out before start up and after close down the Activity.. RESPONSIBILITY: It is the responsibility of operator and production supervisors … Read more

SOP FOR OPENING AND CLOSING OF PRODUCTION DEPARTMENT

SOP FOR OPENING AND CLOSING OF PRODUCTION DEPARTMENT OBJECTIVE: To lay down the procedure for opening and closing of Production Department. SCOPE: This procedure is applicable to opening and closing of Production Department RESPONSIBILITY: It is the responsibility of production chemist/officer to follow the procedure prescribed in this SOP for opening and closing of Production Department. It … Read more

SOP FOR OPERATION AND CLEANING DRY SYRUP FILLING MACHINE

SOP FOR OPERATION AND CLEANING DRY SYRUP FILLING MACHINE OBJECTIVE: To lay down the procedure for operation and cleaning of dry syrup filling machine. SCOPE: This procedure is applicable for operation and cleaning of dry syrup filling machine RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during … Read more

SITE MASTER FILE

SITE MASTER FILE Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections. The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out … Read more

QUALITY MANUAL

QUALITY MANUAL  QUALITY MANUAL describes one comprehensive model for an effective pharmaceutical quality system that is based on the quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements serves as the Validation Road map, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that … Read more