QA & QC

RESOURCES-THE QUALITY SYSTEMS MODEL

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 …

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MANUFACTURING-THE QUALITY SYSTEMS MODEL

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 …

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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 …

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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 …

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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 of QUALITY SYSTEMS MODEL Quality systems call for continually monitoring trends and improving systems. This can be achieved by monitoring data and information, …

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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 …

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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 …

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HPLC Chromatography troubleshooting

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. …

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Change management

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 …

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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 …

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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 …

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REMEDIATION OF DATA INTEGRITY FAILURES

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 …

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Classification of data integrity deficiencies

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 …

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Out of Specification & Out of Trend Investigations as per MHRA

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 …

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HPLC Interview Questions

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 …

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Microbiological Efficacy of the Cycle

Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production cycle need to estabilished. A sterility assurance of 10 or -6 better should be demonstrated for any terminal sterilization process. The level of sterility assurance should be demonstrated for all parts of the drug product …

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Microbiological Monitoring of the Environment

Microbiological Monitoring of the Environment The microbiological monitoring program shall be performed during routine production and media fills and procedure for microbiological monitoring program are clearly defined in SOP. Microbiological monitoring – frequency of monitoring, type of monitoring, sites monitored, alert and action level specifications, and clearly defined procedure for …

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TOOLS FOR QUALITY IMPROVEMENT PART – I

TOOLS FOR QUALITY

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 …

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Human Errors

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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 …

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POST-APPROVAL CHANGE MANAGEMENT PROTOCOL (PACMP)

CHANGE MANAGEMENT PROTOCOL (PACMP) A Change Management protocol (PACMP) is a regulatory tool that provides predictability and transparency in terms of the requirements and studies needed to implement a change that Provides an opportunity for lower reporting category when implementing changes. PACMP tools that allow continued opportunities for streamlined change …

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