1.0 Purpose: To describe the method for dispensing of active raw material from mother bottle to baby bottle as per requirement. 2.0 Aim: This Standard Operating Procedure is applicable to the distribution of active raw material supplied by approved vendor from mother bottle to small sterile bottles as required for formulation of a batch at … Read more
1.0 OBJECTIVE: To lay down the procedure for operation of Automatic Filling and Sealing Machine. 2.0 SCOPE: This procedure is applicable for operation of Automatic Filling and Sealing Machine in liquid department. 3.0 RESPONSIBILITY: 3.1 Operator / Production Staff To operate the equipment/machine as per approved SOP.To clean the equipment after use and keep the … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of vacuum cleaner. 2.0 SCOPE: This procedure is applicable to cleaning of vacuum cleaner used in production department in the Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Ensure that the power supply is turned off.5.2 Transfer the … Read more
1.0 OBJECTIVE: To lay down the procedure for operation and maintenance of DM water plant. 2.0 SCOPE: This procedure applies to DM water plant in Pharmaceuticals. 3.0 RESPONSIBILITY: Production In-Charge, Maintenance personnel, Maintenance Engineer. Learn: SOP for Preventive Maintenance of DM Plant 4.0 PROCEDURE for DM Water Plant: 4.1 PLANT SPECIFICATIONS:Maximum flow rate: 1.2 m3 … Read more
AHU Performance Qualification (PQ) Protocol Objective: The objective of this protocol is to verify that the AHU consistently maintains required environmental conditions during routine operation. Learn the Previous Steps of AHU Qualification: Installation Qualification Protocol for AHUOperation Qualification Protocol for AHU 1.0 PROTOCOL APPROVAL: Submitting this page for Protocol No. is acceptance of the Appendix … Read more
AHU Operational Qualification (OQ) Protocol Objective: The objective of this protocol is to verify that the AHU operates within defined parameters such as airflow, pressure, and filter integrity. 1.0 Protocol Approval: Signing this approval page confirms that the qualification approach described in this protocol is accepted. If any change becomes necessary, it will be handled … Read more
AHU Installation Qualification (IQ) Protocol Objective: The objective of this protocol is to verify that the AHU is installed as per approved design specifications, drawings, and manufacturer recommendations. This AHU Installation Qualification (IQ) Protocol covers the following: Related Topic: Learn Operational Qualification and Performance Qualification of AHU. SERIAL NO. ITEM DESCRIPTION 1.0 Identification and inspection … Read more
1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of holding tank(capacity –3000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of holding tank (capacity –3000 ltrs) in Liquid department Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production departmentManager- Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning and Operation of Holding … Read more
Change Control system SOP, including preparation of Format, Numbering, Initiation, Change & Assessment by QA, Review, Approval, Implementation, Distribution, Retrieval, Annexures, and closing of change control. 1.0 OBJECTIVE: To lay down the procedure for Change Control system SOP. 2.0 SCOPE: This Change Control system SOP is applicable to all related user departments as specified in … Read more
1.0 OBJECTIVE: To lay down the procedure for Cleaning and operation of sparkle filter press. 2.0 SCOPE: This procedure is applicable for cleaning and operation of sparkle filter press in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning and operation of carton over printing machine. 2.0 SCOPE: This procedure is applicable for cleaning and operation of carton overprinting machine in production department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE: for Carton Over Printing Machine5.1 … Read more
1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of linear bottle washingMachine 2.0 SCOPE: This procedure is applicable for cleaning and operation of linear bottle washing machine in Liquid department at Pharmaceutical. 3.0 RESPONSIBILITY:Operator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S):NA 5.0 PROCEDURE:5.1 Cleaning … Read more
1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of manufacturing tank (capacity –1000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of manufacturing tank (capacity –1000 ltrs) at Liquid department in Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production and QA departmentManager – Production and QA Department 4.0 DEFINITION(S)NA 5.0 … Read more
1.0 OBJECTIVE: To lay down the procedure for the Cleaning and Operation of leak test apparatus for filled bottles in Pharmaceutical lab. 2.0 SCOPE: This procedure is applicable to cleaning and operation of leak test apparatus, which is used for Leak test of filled bottles in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer – Production … Read more
1.0 OBJECTIVE: Cleaning Validation Protocol for Multi Mill is designed to ensure that the cleaning procedure for multi mill removes residues to the extent of compliance with pre-determined acceptance level. 2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility. 3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production, and Quality Assurance departments. The … Read more
1.0 OBJECTIVE: Cleaning Validation Protocol for Sifter to ensure that the cleaning procedure for Sifter removes residues to the extent of compliance with pre-determined acceptance level. 2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility (name of company and place) 3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production and Quality Assurance departments. … Read more