Colloid Mill The design of colloid Mills is based on years of experience in wet communication, homogenization, emulsification, dispersion, fluidization mixing, etc. The principle of the Colloid Mill is based on the Stator /Rotor Principle. The stator is ring-shaped with two different staggered special design tooth stages and conical shape tuning inside the stator with…
Installation qualification of Gelatin Melting Reactor PURPOSE: To describe the Installation Qualification of the Gelatin Melting Reactor and its accessories and to define the Specification of the system: Ensure that the equipment meets the specifications as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation…
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SOP for Design Qualification of Blister Packing Machine (Model – BQS) OBJECTIVE To design, engineer, and supply the Blister Packing Machine (Model: BQS) and to ensure that 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…
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SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules OBJECTIVE : To provide a procedure for representative sampling of In-process blends, uncoated tablets, coated tablets and filled capsules. RESPONSIBILITY : Officer – Quality Assurance. Head – Quality Assurance to ensure compliance. PROCEDURE : After receiving the “Inprocess Analysis Request and report…
Installation qualification of Blister Packing Machine (Hoonga) PURPOSE To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (Hoonga), its accessories and to define the Specification of the system in order to Ensure that the equipment meets the specification as Design Qualification. Aid verification of the installation as per equipment…
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Operational qualification protocol of Gelatin Melting Reactor PURPOSE: To describe the Operational Qualification of 300 L Gelatin Melting Reactor, and 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…
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SOP for Operational Qualification of Capsule Printing Machine PURPOSE: To describe the Operational Qualification of Capsule Printing Machine its accessories and to define the specification of the system in order to: ensure that the machine meets the Operational / Design limits as per user requirements ensure that the machine will be operationally qualified in accordance…
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SOP for Design Qualification of Capsule Printing machine OBJECTIVE To design, engineer, and supply the Capsule Printing Machine and to provide assurance that the machine is manufactured as per the URS and it comply with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there…
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SOP for Installation Qualification of Capsule Printing machine PURPOSE To describe the Installation Qualification of Capsule printing machine, 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…
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SOP FOR OPERATIONAL QUALIFICATION of Soft Gelatin Encapsulation System PURPOSE To describe the Operational Qualification of Arbes Encapsulation System (CAP-X-8) along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per users requirements. ensure that…
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SOP on Drug Product Recalls OBJECTIVE : To define the procedures used to effect the recall of a marketed product once it has been decided that such a course of action is required. RESPONSIBILITY : The Managing Director and Divisional Head shall be responsible for making the decision that a recall is necessary, based on…
Issuance and Evaluation of Investigation Reports OBJECTIVE : To establish a documentation system by which qualified representatives report and investigate the exceptions of drug products in the manufacturing process, in-process specifications. RESPONSIBILITY : Executive – Production/Packaging to prepare the Exception Investigation Report (EIR). Head – Production to investigate and implement necessary corrective actions. Head – …
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SOP on Process Validation Programmed in Pharmaceutical Company OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research Development to prepare and execute the validation protocol and to prepare a final…
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Preparation, Approval, Issue, and Control of Artworks for labeling of Pharmaceutical products OBJECTIVE : To lay down the Procedure for Preparation, Approval, Issue, and Control of artworks for labeling of pharmaceutical products. RESPONSIBILITY : R&D(Packaging Development) to prepare the Artwork, positive or soft copy, and procure shade cards & specimens from the printers. QA (Documentation)…
Calibration for Weighing Balances In various industries, such as pharmaceuticals, laboratories, manufacturing, and research, precise measurements are of utmost importance. Weighing balances are essential instruments that enable us to obtain accurate measurements, making them crucial in ensuring the quality of products, integrity of research, and compliance with regulatory standards. Calibration is a fundamental process that…
Calibration procedure for halogen moisture analyzer OBJECTIVE To lay down the procedure for calibration of the Halogen moisture analyzer, SCOPE This SOP shall provide the calibration procedure of the Halogen moisture analyzer in the in-process quality assurance department and quality control department. RESPONSIBILITY Officer/ Executive – Quality Control/Quality Assurance. ACCOUNTABILITY Head QC/QA PROCEDURE Precautions: Make …
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Handling of Returned Pharmaceutical Products OBJECTIVE : To establish a procedure for the Inspection and Handling of Returned Drug Products. RESPONSIBILITY : Head – Warehouse to inform Head QA about the product returned. Officer Warehouse to identify the product returned, against documents received and to verify the physical conditions of the received drug product. Officer…
SOP For calibration of disintegration test apparatus OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus. SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus . RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Check the water level in the water bath. Fill the water in…
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SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO) OBJECTIVE To lay down the procedure for Calibration of Autotitrator (METTLER TOLEDO DL50). SCOPE This SOP shall be applicable for the Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched…
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Procedure for calibration of the calculator OBJECTIVE To lay down the Procedure for Calibration of the calculator. SCOPE This SOP provides guidance to calibrate the calculators, which are used for simple and complex calculations of analysis in the quality control department. Scientific calculator Desktop calculator Calculator used in the computer (Windows Version 98, 2000, 2003,…
