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 … Read more
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; … Read more
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 in the healthcare system. How … Read more
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 … Read more
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 innovative solution not only enhances … Read more
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. Its versatility, sensitivity, and ability … Read more
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 the environment in mind. In … Read more
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 … Read more
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 automating the application of labels … Read more
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 results in quality drugs available … Read more
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, processing, packing, or holding do … Read more
Reference-Standard and Working Standards The US Food and Drug Administration defines a reference-standard material as a “highly purified compound that is well characterized” (1). The US Pharmacopeia (USP) defines reference-standard materials as “highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators” (2). Scientists performing analytical testing use reference … Read more
REMEDIATION OF DATA INTEGRITY FAILURES Data Integrity issues responding – Consideration should be primarily given to resolving the immediate issues identified and assessing the risks associated with the data integrity issues. The response by the company in question should outline the actions taken as part of a remediation plan. Responses from implicated manufacturers should include: … Read more
Classification of data integrity deficiencies Data integrity to aid consistency in reporting and classification of data integrity deficiencies. Deficiencies relating to data integrity failure may have varying impacts on product quality. Prevalence of the failure may also vary between the actions of a single employee to an endemic failure throughout the inspected organization. Data integrity … Read more
Bung Processor / Autoclave Definition of Autoclave An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different to ambient air pressure. Autoclave is used in medical application to perform sterilization, and in the chemical industry to cure coatings, vulcanise rubber and for hydrothermal synthesis. Definition of Sterilization … Read more
Turn Tables Boosting Efficiency: Streamlining Material Handling and Process Optimization Turn tables, also known as rotary tables or revolving tables, are versatile and innovative equipment that revolutionize material handling and process optimization. These rotating platforms enable smooth and controlled movement of products, components, or equipment, enhancing efficiency, reducing manual labor, and improving overall productivity. In … Read more
Out of Specification & Out of Trend Investigations as per MHRA Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: • Batch release testing and testing of starting materials. • In-Process Control testing: if data is used for batch calculations/decisions and if … Read more
HPLC HPLC (High-Performance Liquid Chromatography) is a powerful analytical technique used for separating, identifying, and quantifying components in a mixture. It operates on the principles of liquid chromatography, with a liquid mobile phase carrying the sample through a stationary phase. The distinguishing feature of HPLC is the application of high pressure to enhance the separation … Read more
NITROGEN GAS DISTRIBUTION SYSTEM WELDING AND CLEANING DETAILS CERTIFICATION Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client. 10% of all orbital welded connections and 100% of all … Read more
PURIFIED WATER WELDING AND CLEANING DETAILS CERTIFICATION Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client. 10% of all orbital welded connections and 100% of all manually welded … Read more