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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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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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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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;…
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…
OPERATION, CLEANING, AND CALIBRATION PROCEDURE OF DISINTEGRATION TEST APPARATUS
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…
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:…
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…
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…
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TOOLS FOR QUALITY IMPROVEMENT PART – I teams of people working together on projects in order to achieve pre-defined quality objectives or Eliminate the root cause(s) of a specific problem is an integral part of ST culture. To ensure that all these team members are sufficiently equipped to undertake their projects. This requires a basic…
Human Errors Understanding Human Errors Regulatory expectations The current way of handling human errors Types of human errors Investigation of human errors CAPAs Case study Human Error Is The Leading Cause Of GMP Deviations – 25-60% of the deviations / Incidents in the companies are caused by human errors Human Errors Regulatory expectations {(as per…
Quality management Review
What are the different types of Quality Management systems (QMS)? Quality management is an essential system that every company should have in place. It is a set of practices that help companies identify, measure, and control the quality of their products. They help identify potential hazards before they become problems and can be used as…
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What is future mapping? “Future Mapping” is a remarkable new technology for problem-solving, creativity, and innovation. It involves a map with six areas to create an action scenario to achieve your goal … far more advanced than current methods … … reverses existing ideas on goal achievement … … turns thoughts into concrete action plans … Because…
OUT OF SPECIFICATIONS (OOS) Out of Specification (OOS) means the test result that falls outside the specifications or acceptance criteria which has been specified in the official compendia monographs or the finished product specification in registration dossiers. OOS IS OBSERVED IN THE ANALYSIS OF: Stability study Finished product In-process Raw materials Packing materials Identification of…
SOP for Quality Assurance Policy Quality assurance policies are to ensure that routine and continuous quality improvement is an essential, and fundamental part of our organization. Controlling change will aim for continuous improvement in the quality of all aspects of its work as part of its determination to help to get achieve the highest possible…
ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION The quality objective of manufacturers is to ensure that products are fit for their intended use, comply with the requirements of the Marketing Authorisation (MA) and do not place patients at risk due to inadequate safety, quality, or efficacy. The fulfillment of quality objectives is the duty of senior…
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RISK MANAGEMENT METHODOLOGY – ICH Q9 Quality risk management (QRM) – a scientific and practical approach to decision-making. QRM provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity, and detectability of the risk. Quality risk management (QRM) In general, risks…
TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9 TABLE OF CONTENTS 1. INTRODUCTION…………………………………………………………………………………………………1 2. SCOPE………………………………………………………………………………………………………………..2 3. PRINCIPLES OF QUALITY RISK MANAGEMENT…………………………………………………2 4. GENERAL QUALITY RISK MANAGEMENT PROCESS…………………………………………..2 4.1 Responsibilities ………………………………………………………………………………………………… 3 4.2 Initiating a Quality Risk Management Process ……………………………………………………. 3 4.3 Risk Assessment……………………………………………………………………………………………….. 3 4.4 Risk Control……………………………………………………………………………………………………… 4 4.5 Risk Communication…………………………………………………………………………………………. 5 4.6 Risk…
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