Tag: Belarus

Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store

Posted on By Abha Maurya

Cleaning of Raw Material Store, Packing  Material Store and Finished Goods Store Procedure Collect all the waste material, dust settled over tables, floors, containers, furniture, fixtures & walls with the help of a vacuum cleaner. Clean the door, window glasses, door closures, handles, and all the hinges of the door using a clean dry duster…

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Warehouse

Dispensing of raw materials and transfer of dispensed materials from RM store to Production

Posted on By Abha Maurya

Dispensing of raw materials and transfer of dispensed materials from RM store to Production Pre-start-up activity for dispensing & Issuance of Raw material: On the receipt of the requisition slip from the production department for the manufacture of a product, the store personnel shall ensure that the requisition slip bears the signature of all the…

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Warehouse

Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Posted on By Abha Maurya

Stock Rotation of Raw Materials, Packing Materials, and Finished Goods on the “First-in, First-out” basis Objective To lay down a procedure to ensure proper stock rotation of Raw materials, Packing Materials, and Finished Goods so that the stock rotation of the materials may be on the “First-in, First-out” basis. Scope This Standard Operating Procedure is…

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Warehouse

Inventory Control of Materials and Components

Posted on By Abha Maurya

Inventory Control of Materials and Components Procedure Raw Material Store, Packing Material Store and Finished Goods Store shall maintain proper records with respect to the Inventory Control of Materials and Components. Inventory Control regarding Raw Materials:-The following records shall be maintained by the Incharge of the Raw Material Store in which necessary inventories shall be…

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Warehouse

ELECTRONIC RECORDS

Posted on By Abha Maurya

ELECTRONIC RECORDS  Scope (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that…

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Quality Assurance

Water Analysis as per IP/BP/USP

Posted on By Abha Maurya

Water Analysis  as per IP/BP/USP Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. The precautions taken to avoid contamination must be…

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Quality Control

RESOURCES-THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

RESOURCES-THE QUALITY SYSTEMS MODEL Appropriate allocation of resources is key to creating a robust quality system and complying with the CGMP regulations. This section discusses the role of resources in developing, implementing, and managing a robust quality system that complies with CGMP regulations. 1. General Arrangements Under a robust quality system, sufficient resources should be…

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Quality Assurance

MANUFACTURING-THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

MANUFACTURING-THE QUALITY SYSTEMS MODEL Significant overlap exists between the elements of a quality system and the CGMP regulation requirements for manufacturing operations. It is important to emphasize again that FDA’s enforcement programs and inspectional coverage remain based on the CGMP regulations. When quality system elements in this section do not correlate to the CGMP regulations,…

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Quality Assurance

MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL The goal of this section is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe the…

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Quality Assurance

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS

Posted on By Abha Maurya

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to the manufacture of pharmaceutical products. A. Quality Every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the…

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Quality Assurance

EVALUATION ACTIVITIES – THE QUALITY SYSTEMS MODEL

Posted on By Abha Maurya

EVALUATION ACTIVITIES – THE QUALITY SYSTEMS MODEL The elements of a quality system correlate closely with the requirements in the CGMP regulations. 1. Analyze Data for Trends of QUALITY SYSTEMS MODEL Quality systems call for continually monitoring trends and improving systems. This can be achieved by monitoring data and information, identifying and resolving problems, and…

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Quality Assurance

USFDA Guidance on Quality Metrics

Posted on By Abha Maurya

USFDA Guidance on Quality Metrics Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers;…

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Quality Assurance

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

Posted on By Abha Maurya

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules A. Differences in Size and Shape of Tablets and Capsules between a Reference Listed Drug and a Drug Product Subject to an Abbreviated New Drug Application 1. Size Difficulty swallowing tablets and capsules can be a problem for many individuals and can lead to…

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Production

Enhancing Efficiency with Automatic Rotary Type Measuring Cup Placement

Posted on By Abha Maurya

Automatic Rotary Type Measuring Cup Placement In the fast-paced manufacturing world, efficiency and accuracy are crucial for success. Automatic rotary-type measuring cup placement is a cutting-edge technology that revolutionizes measuring and placing cups onto containers or packaging in various industries. This innovative solution not only enhances productivity but also ensures precise measurements and consistent product…

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Validation & Qualification

Continued Process Verification As Per WHO TRS1019 Annex 3

Posted on By Abha Maurya

Continued Process Verification As Per WHO TRS1019 Annex 3 Manufacturers should monitor the product quality of commercial batches after completion of process design and process qualification. This will provide evidence that a state of control is maintained throughout the product life cycle. The scope and extent of process verification will be influenced by a number…

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Production

Revolutionizing Product Packaging with Bottle Sticker Labelling Machines

Posted on By Abha Maurya

Revolutionizing Product Packaging with Bottle Sticker Labelling Machines In today’s competitive market, effective product packaging plays a crucial role in capturing consumer attention and promoting brand recognition. The bottle sticker labeling machine is a cutting-edge technology that streamlines the labeling process for bottles, ensuring accuracy, efficiency, and aesthetic appeal. By automating the application of labels…

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Validation & Qualification