Tag Archives: Antrim and Newtownabbey

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 …

IQ OF AUTOMATIC ROTARY TYPE MEASURING CUP PLACEMENT Contents Pre Execution Approval Objective Equipment Description Participants Log Installation Qualification Checklist Sub-Component CheckList Component Location List MOC Verification List Test / Inspection Reports Utility Verification List Attachment Log Summary, Conclusion, and Recommendation Abbreviations Post Execution Approval PRE-EXECUTION APPROVAL Prepared by By …

Troubleshooting There is no standard troubleshooting procedure. General Pattern: Locate the problem by ranking possible causes. Verify the presence of the most probable cause. If present – fix the problem, otherwise verify the existence of the next possible cause. Two Types  of HPLC troubleshooting System problems or Method problems HPLC …

Change management As Per WHO TRS1019 Annex 3 Manufacturers should follow change-control procedures when changes are planned to existing systems or processes. The change-control procedure and records should ensure that all aspects are thoroughly documented and approved, including regulatory approval where appropriate (variation). Sufficient data should be generated to demonstrate …

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 …

DESIGN QUALIFICATION OF AUTOMATIC VERTICAL ROUND BOTTLE STICKER LABELLING MACHINE The Automatic Vertical Round Bottle Sticker Labeling Machine is one of the most users friendly. The machine is used for full/partial wrap around labeling on different size of round containers. It is capable of labeling up to 80 to 120 …

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 …

USFDA 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, …

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 …