MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL

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 … Read more

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS

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 … Read more

EVALUATION ACTIVITIES – THE QUALITY SYSTEMS MODEL

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 Quality systems call for continually monitoring trends and improving systems. This can be achieved by monitoring data and information, identifying and resolving problems, and anticipating and preventing problems. … Read more

USFDA Guidance on Quality Metrics

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 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

HPLC troubleshooting

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 System Components •Pump •Injector/ Autosampler … Read more

Change management As Per WHO TRS1019 Annex 3

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 that the revised process will … Read more

Quality Metrics in pharmaceutical industry

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

Reference-Standard and Working Standards

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

REMEDIATION OF DATA INTEGRITY FAILURES Responding to Significant Data Integrity issues 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 … Read more

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