Tuesday , May 26 2020

Recent Posts

Installation Qualification of Encapsulation Machine

PURPOSE To describe the Installation Qualification of Encapsulation Machine 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 specification as Design Qualification aid verification of the installation as per equipment general arrangement …

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Facility Validation in pharmaceutical Company

Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce …

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How to face Interview

Remember, you never get a second chance to make a good first impression. However, good preparation takes the pain out of the process. Interview Preparation Remember: Prepare, prepare, prepare! Preparation is essential and greatly enhances your chances of performing well, So: know your CV know your potential employer understand commonly …

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Operational qualification protocol of Blister Packing Machine (BQS)

PURPOSE To describe the Operational Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to define the specification of the sytem in order to: Ensure that the equipment meets the Operational/Design limits as per user requirements Ensure that the equipment will be operationally qualified …

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Design Qualification of Colloid Mill

OBJECTIVE To design, engineer, and supply the Colloid Mill and to provide assurance that the machine is manufactured and it comply 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 at utmost …

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Installation qualification of 300 L Gelatin Melting Reactor

PURPOSE: To describe the Installation Qualification of 300 L Gelatin Melting Reactor 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 …

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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 same at utmost transparency. Validation procedure …

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Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules

OBJECTIVE : To provide 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 / Inprocess analysis request for commercial batches/Analysis Request “(Annexure …

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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 general arrangement …

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Operational qualification protocol of Gelatin Melting Reactor

PURPOSE: To describe the Operational Qualification of 300 L Gelatin Melting Reactor, 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 …

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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 with current Good …

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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 in the document, …

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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 the system installation …

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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 the equipment will be …

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SOP on Training

SOP on Training Objective: To lay down a procedure to conduct training of working personnel at all levels and its evaluation. Scope: This Standard Operating Procedure is applicable for training of personnel at Pharmaceuticals Company. Responsibility Head, QA or his/her designee for co-ordination on training of the personnel. Head of every department …

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SOP on Drug Product Recalls

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  …

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Issuance and Evaluation of Product Exception Investigation Reports (“EIRs”).

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 …

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SOP on Process Validation Programmed in Pharmaceutical Company

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 …

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Preparation, Approval, Issue and Control of Art works for labeling of Pharmaceutical products

Preparation, Approval, Issue and Control of Art works for labeling of Pharmaceutical products OBJECTIVE : To lay down the Procedure for Preparation, Approval, Issue and Control of  art works for labeling of pharmaceutical products. RESPONSIBILITY : R&D(Packaging Development) to prepare the Art work, positives or soft copy, and procure shade …

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Procedure for calibration of weighing balances

Procedure for calibration of weighing balances OBJECTIVE To lay down a procedure for calibration of weighing balances. SCOPE The Standard Operating Procedure is applicable to In process Quality Assurance areas. RESPONSIBILITY Concerned Technician ACCOUNTABILITY Inprocess Quality Assurance Executive/ Officer. PROCEDURE DAILY CALIBRATION Before calibrating the balance, clean the weighing platforms. …

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