Code to Code Transfer of Materials and Additional Testing of Materials / Products

Code to Code Transfer of Materials and Additional Testing of Materials / Products Objective (procedure) To lay down a procedure for code transfer of the same material from one code to another and to carry out additional testing of APIs, Excipients, and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard operating … Read more

CALIBRATION MASTER PLAN

CALIBRATION Calibration is an essential procedure that involves the adjustment and validation of measurement instruments to guarantee their accuracy and consistency in providing dependable results. This practice holds immense significance across diverse sectors including manufacturing, healthcare, research, and others. In the absence of meticulous calibration, errors can permeate throughout operations, resulting in subpar outcomes, escalated … Read more

SOP on In-process sampling of semi-finished product

SOP on In-process sampling of semi-finished product Objective: To lay down the procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product  in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished product samples. Production personnel are … Read more

SOP on execution of exhibit batches

SOP on the execution of exhibit batches  Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharmaceutical company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability The Head of the … Read more

SOP on withdrawal, storage, observation & destruction of control/retention sample

SOP on withdrawal, storage, observation & destruction of control/retention sample Objective: To lay down the procedure for withdrawal, storage, observation & destruction of control/retention sample from production (Oral & Injectable), Q.C. (RM Retention) . Scope: This SOP is applicable for the withdrawal, storage, observation & destruction of control samples from production (Oral & Injectable), and … Read more

SOP on preparation, control, issuance and revision of Batch Manufacturing and Batch Packing Records

SOP on preparation, control, issuance, and revision of Batch Manufacturing and Batch Packing Records Scope: This procedure is applicable to the manufacturing & packing records being generated at the formulation Plant of a Pharmaceutical company. Responsibility: Executive Production – Preparation of BMR / BPR. Head Production / nominee – Checking / Review of BMR / … Read more

SOP on line clearance

SOP on line clearance Objective: To lay down the procedure for line clearance of manufacturing, warehouse . This is to ensure that the start up of any production/ process is free from previous material/contaminants.  Scope: This SOP is applicable for line clearance of production (oral), warehouse areas of Formulation plant. Responsibility: Operator/ Supervisor shall be … Read more

SOP on Monitoring of Temperature, Relative Humidity and Pressure Differential

SOP on Monitoring of Temperature, Relative Humidity, and Pressure Differential Objective: To lay down a procedure for monitoring temperature, relative humidity, and differential pressure in controlled areas. Scope: This SOP is applicable for monitoring and recording the temperature (°C), Relative humidity (%), and differential pressure (Pa) in controlled areas using a wet and dry bulbs … Read more

SOP on Technology Transfer for Analytical Method

SOP on Technology Transfer for Analytical Method Objective: To lay down the procedure for the Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for the Transfer of technology for Analytical Methods from ARD to a Pharmaceutical Plant. Responsibility: The responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol … Read more

SOP on Transfer of Technology for Manufacturing process

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for the Transfer of Technology for the Manufacturing Process. Scope: This procedure is applicable for the Transfer of technology (i.e. for the Manufacturing process) from sending unit ( R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibilities of Sending Unit (R&D … Read more

SOP on Execution of Exhibit Batches

SOP on Execution of Exhibit Batches  Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharma Company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability The Head of the Department … Read more

Operational Qualification of Ointment Manufacturing Vessel

Operational Qualification of Ointment Manufacturing Vessel PURPOSE: To describe the Operational Qualification of Ointment Manufacturing Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing … Read more

Installation Qualification of Ointment Manufacturing Vessel

  Installation Qualification of Ointment Manufacturing VesselPURPOSE To describe the Installation Qualification procedure to be used during qualification of Ointment Manufacturing Vessel, its accessories and to define the Specification of the system in order to Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general … Read more

Design Qualification of Ointment Manufacturing Vessel

  Design Qualification of Ointment Manufacturing VesselOBJECTIVE To design, engineer, and supply the Ointment Manufacturing Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same … Read more

Design Qualification of Blister Packing Machine (Model – BQS)

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control procedure Qualification Document report approval Appendix … Read more

SOP on Procedure for storage of sterilized rubber stoppers in aseptic area .

Objective To lay down the procedure for storage of sterilized rubber stoppers in aseptic area. Scope This SOP is applicable for storage procedure of sterilized rubber stoppers in aseptic area Production dry powder Injectable facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP  : Standard … Read more

Purified Water -Design qualification pretreatment, generation system

Purified Water -Design qualification pretreatment, generation system To design the equipment / instrument in conjunction with the design data in order to provide basis for vendor, manufacturer & / or the design engineer for designing the system when the project begins. To prepare detailed specification for all major components of Equipment / instrument to ensure … Read more

Operational qualification for WFI generation plant

Operational qualification for WFI generation plant OBJECTIVE To establish documentary evidence to demonstrate the WS system is qualified for correct operation as per guidelines outlined in this protocol & operational manual SCOPE OF THIS DOCUMENT This protocol is applicable to multi column water. RESPONSIBILITES  Inspection  Customer or their authorized representatives are responsible for this SAT … Read more

Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station

OBJECTIVE To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document are the … Read more

Installation Qualification of Medicament Preparation Vessel

PURPOSE: To describe the Installation Qualification of Medicament Preparation Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation meets acceptance criteria. Ensure that … Read more