Tag Archives: North

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 …

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 …

INSPECTIONS/AUDITS 1. Manufacturing Process i. Drug Product (Dosage Form) In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a …

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 …

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 …

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 …

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 …

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 …

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 …

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, …

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 …

Quality Measures Quality measures are designed to drive healthcare quality, and they also influence measured entity payments, reduce risks to individuals, and affect measured entity burden. That is why it is so important that quality measures be vetted to verify that they do, in fact, indicate quality and drive quality …

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 …

Enhancing Efficiency with Automatic Rotary Type Measuring Cup Placement In the fast-paced world of manufacturing, efficiency and accuracy are crucial factors for success. Automatic rotary type measuring cup placement is a cutting-edge technology that revolutionizes the process of measuring and placing cups onto containers or packaging in various industries. This …

HPLC Chromatography High-Performance Liquid Chromatography (HPLC) has revolutionized the field of analytical chemistry, offering a powerful and versatile tool for separating, identifying, and quantifying compounds in complex mixtures.  High-Performance Liquid Chromatography has become an indispensable tool in various scientific disciplines, contributing significantly to advancements in research, quality control, and diagnostics. …

Change management As Per WHO TRS1019 Annex 3 Change management is the process that uses to identify, document and authorize changes in approved standard documents  & procedure to minimizes the likelihood of disruptions, unauthorized alterations and errors. The change control procedures should be designed with the size and complexity of …

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 …

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 labelling machine is a cutting-edge technology that streamlines the labelling process for bottles, ensuring accuracy, efficiency, and aesthetic appeal. By …

Quality Metrics in pharmaceutical industry Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. Quality Metrics play an important role in the desired state of pharmaceutical quality and regulation – minimal but effective regulatory oversight that …

FDA 483 Warning Letter Dated MARCH 30, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, …