Imprimis Pharmaceuticals USFDA warning Letter 12/21/17
Imprimis Pharmaceuticals USFDA warning Letter 12/21/17 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
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Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17
Continental Manufacturing Chemist, Inc. USFDA warning Letter 12/21/17 For Warning Letter Click here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Investra-24hs USFDA warning Letter 12/28/17
Investra-24hs USFDA warning Letter WARNING LETTER The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites (listed at the bottom of this letter) and determined that they offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved new drugs…
Casmara Cosmetics, S.A. USFDA warning Letter 2/12/18
Casmara Cosmetics, S.A. USFDA warning Letter 2/21/18 For Warning Letter Click the Link – Casmara Cosmetics, S.A. 2/12/18 For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
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…
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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…
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…
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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…
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…
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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 /…
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…
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…
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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…
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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…
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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…
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…
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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…
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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…
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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…
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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…
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