Quality Control and Quality Assurance – The Difference

Introduction Stringent global pharmaceutical regulations on quality ensure that all manufacturers and distributors in the pharmaceutical circuit maintain high quality of medicinal products. Every organization has a quality manual of its own that outlines the responsibility of each personnel in upholding quality at each step of the product lifecycle. Such a system not only encourages

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Making GMP training relevant

Good Manufacturing Practice (GMP) GMP is a system that ensures consistent production of high quality products. GMP processes at each stage of production aids in maintaining the quality of every finished batch and helps eliminate errors that cannot be rectified in a finished product.1,2 Most countries have developed GMPs by adapting GMP guidelines laid down

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FDA’s New Social Media Policy

The social media policy of FDA applies to all employees and contractors of the drug administration. The policy outlines expectations and guidelines to encourage healthy use of technologies that support FDA’s communication and exchange of credible information with the primary interest of protecting and promoting public health. Definition and scope of the policy FDA defines

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Pharmacovigilance

What is pharmacovigilance? Pharmacovigilance is a branch in clinical research that involves all activities related to drug surveillance to track, detect, and assess adverse events and possible idiosyncrasies related to the drug. In response to the thalidomide tragedy in 1961, the WHO promoted global pharmacovigilance programs to ensure patient care and safety.1 The WHO program

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FDA’s review of NDA in the drug approval process

Introduction A new drug application (NDA) is submitted by the Sponsor company when the Sponsor intends to market the drug in the United States. An NDA should include crucial information such as drug manufacturing process, drug pharmacokinetics and pharmacodynamics, as well as all relevant human and animal research data.1 In addition, the application should have

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Clinical trials in the FDA drug approval process

Introduction The FDA has laid down several rules and regulations to protect individuals who volunteer to take part in clinical trials. FDA also emphasizes and upholds the need to safeguard participants from foreseeable risks and plays an influential role in encouraging pharmaceutical and biotechnology companies to ensure that they provide detailed and step wise drug

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THE 10 PHASES OF AN EFFECTIVE CAPA

The U.S. Food and Drug Administration, as well as other regulatory agencies view Corrective and Preventive Action (CAPA) as the central component that influences all control segments.  This includes design, production and process controls. It also encompasses documents change controls, material controls, facility and equipment controls. The worst thing that can happen is a sudden

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MANAGING QUALITY CONTROL LABORATORY RECORDS

What is Laboratory Quality? Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. Every Laboratory should have standardized forms to support the Laboratory Quality system. Once  the  forms are used to record information, they become records. What are Records? Records are the proof of the Laboratory quality and they must

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Writing Effective Deviation Investigations

Deviation investigations are a very common topic to be reviewed during FDA investigations.  Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.  Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls. Proper root

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An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations

According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we

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Effective Analytical Method Transfer Between Two Labs

As per the USP, the transfer of an analytical method is defined as the documented process that qualifies a laboratory (receiving laboratory) to use an analytical method that originated in another laboratory (transferring laboratory), whether that is internal or external to the receiving laboratory. These two types of laboratories can have varying relationships. The improvement

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