Tag Archives: Myaanmar (Burma)

WATER PURIFICATION -VALIDATION AND QUALIFICATION Establishing reliability of pharmaceutical water purification, storage, and distribution systems requires demonstrating control of the process through an appropriate period of monitoring and observation. Finished water is typically continuously produced and used, while product and process attributes may only be periodically assessed. The quality of bulk …

ANALYTICAL INSTRUMENT QUALIFICATION A large variety of laboratory equipment, instruments, and computerized analytical systems  are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst’s objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the …

Analytical Instrument Categories Users are  establishing the level of qualification needed for an instrument. On the basis of the level needed, it is to categorize instruments into three groups: A, B, and C, as  for detail defined below. Examples of instruments in each group are provided. Note that the list of instruments …

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 …

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, …

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 …

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. …

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 …

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 …

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. …

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 …

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 : …

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: …

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 …

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 …

  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 …

  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 …

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 …

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 …

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 …