Water Analysis as per IP/BP/USP Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. The precautions taken to avoid contamination must be…
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 system, sufficient resources should be…
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 correlate to the CGMP regulations,…
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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