IND, or the Investigational New Drug Application, is a U.S. permission process required to move any new medicine or therapy from laboratory research to human testing, meaning clinical trials. For example, imagine scientists have developed a new medicine. They cannot directly test it on humans. First, they must submit proof to the U.S. drug authority through an … Read more
Self-inspection, also known as an internal audit, is a routine check that pharmaceutical companies run on their own to check the gaps between the procedures and documents. All manufacturing and quality teams must follow this process to maintain compliance. We can say it is a review that checks if daily work matches Good Manufacturing Practices … Read more
1.0 Scope: Procedure is applicable to perform the colour test of the sample wherever specified. Learn: Procedure to Check Clarity of Sample Solution 2.0 Apparatus:You will need: 3.0 Reagents:Use analytical grade (AR) chemicals for the following: 4.0 Method: A. Ferric Chloride Colorimetric Solution (FCS) Dissolve roughly 55 g of ferric chloride hexahydrate in a mixture … Read more
1.0 Scope: This procedure is applicable to check the clarity of sample solution. Learn: Laboratory Color Test Procedure 2.0 Apparatus: 3.0 Reagents: 4.0 Method:4.1 Preparation of Standard Suspension:First, take 1.0 g of hydrazine sulphate. Dissolve it in enough purified water to make exactly 100.0 ml. Leave the mixture aside for about 6 hours. Next, take … Read more
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