When Must You Calibrate Your Test Equipment

Calibration of an instrument involves comparing the measurements of two instruments, one which has a known magnitude (also known as the standard) against the instrument whose unit measure is under the test. The calibration standard must be more accurate than the instrument under test. Calibration establishes a relation between a) the quantity values with measurement […]

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Things You Need To Know About cGMP

CGMP or Current Good Manufacturing Practice regulations are enforced by the US Food and Drug Administration (FDA). They provide for systems which can assure proper monitoring, design and control of manufacturing processes and facilities. By adhering to CGMP regulations, you can assure the quality, strength and purity of any product manufactured by a company. You […]

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All About the Quality Management System

Quality Management System refers to a set of processes, policies and procedures that are required for planning and execution in any core business area of a company. It is a system that an organization follows to reduce and eventually eliminate non-conformance to standards, specifications and expectations of a customer in a cost efficient manner. Some […]

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The Role of Quality Assurance in the Pharmaceutical Industry

Quality assurance is a wide concept that covers all aspects that collectively or individually impact the quality of the product. That is, the sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use. Quality assurance is a good practice in the […]

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Project Management Services for Maintaining Pharmaceutical Quality

Project management is a set of processes designed to help make a project effectively see the light of day. It is a discipline that widely accepted across various industries and its principles can be applied to any and every sector, especially manufacturing. In addition to assigning responsibility to key stakeholders, it also entails regular monitoring […]

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What Does a Quality Engineer Do?

As the name suggests, a quality engineer is someone who has been thoroughly trained to inspect, monitor and test various products and services to see they all meet the specified standards they are required to, especially in industries that are heavily regulated by the FDA and other agencies. A quality engineer is a qualified and […]

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Internal & External Checks: Quality Assurance, Control, and Assessment Measures

Quality monitoring in production lines and industrial processes needs to be assessed on two basic factors – assessing the accuracy (how close your results are to actual figures) and gauging the precision (the repeatability of the results). The various aspects involved in this process can be divided into quality assessment measures, and quality assurance/control. Let’s […]

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Importance of Prerequisite Verifications in Equipment Qualification

Equipment qualification is an essential step that companies need to perform in order to ensure that their products or services meet manufacturing and testing requirements. It is especially crucial for businesses that manufacture medical devices and instruments, since these are treated the same as equipment used in manufacturing. Prerequisites are a form of documented verification […]

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When is installation Qualification required?

Accuracy and high precision in instruments that are used in pharmaceutical companies, health care industries and small laboratories is critical. This is mainly because the data obtained is what is used as a guideline in getting the correct diagnosis. What do DQ, IQ, OQ and PQ refer to in equipments? Prior to acquiring a new […]

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What is IQ OQ PQ?

For industries involved in pharmaceutical and health care products, or even laboratories, product quality is paramount and minute inconsistencies can have disastrous results. Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are an essential part of quality assurance through equipment validation. What Do IQ, OQ and PQ Mean? IQ OQ PQ protocols are […]

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