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Management Review in Pharmaceutical Industry

PharmaWhiz Author October 31, 2020 Management Review in Pharmaceutical Industry2020-10-31T17:24:22+00:00 Others 2 Comments
As you know, pharmaceutical industry is a regulated industry and makes products that directly affect the health of the patient. Because all these pharmaceutical products are administered by the patient, then…
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Risk Management Approach

PharmaWhiz Author August 21, 2020 Risk Management Approach2020-08-22T09:12:45+00:00 QMS 3 Comments
What should be the Risk Management Approach, We all recognize that risk management could be a very good tool to avoid any major failure or disaster with in the future if we actually…
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Trend Analysis a tools for Risk-Based thinking

PharmaWhiz Author May 10, 2020 Trend Analysis a tools for Risk-Based thinking2020-11-28T13:46:43+00:00 Good Manufacturing Practices 5 Comments
The biggest concern in this Regulatory Challenging Environment is to apply risk-based thinking for implementing, deploying and maintaining a quality management system with limited resource There is a significant concern…
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COVID-19 (Corona Virus) and Unethical Business

PharmaWhiz Author March 10, 2020 COVID-19 (Corona Virus) and Unethical Business2020-07-11T06:32:23+00:00 Others No Comment
On one side, China & other countries across the world are struggling with the infection of COVID-19 (Corona Virus) and on the other side, some selfish people are selling unapproved products…
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5 ways to reduce Human Error

PharmaWhiz Author February 8, 2020 5 ways to reduce Human Error2020-07-08T10:46:38+00:00 Good Manufacturing Practices No Comment
"The great majority of reported defective medicinal products has resulted from human error or carelessness, not from the failure of technology"  Source: MHRA, Orange Guide 2002 As stated by Orange Guide…
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Statistical Analysis of MHRA 2018 GMP Inspection’s Deficiencies

PharmaWhiz Author January 8, 2020 Statistical Analysis of MHRA 2018 GMP Inspection’s Deficiencies2020-08-21T11:31:10+00:00 Audit & Compliance 2 Comments
MHRA published its GMP Inspection Deficiency Data for the year 2018. In totality MHRA Inspectorate audited 286 facilities across the globe in the year 2018 and made total 6209 deficiencies…
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Quality Oversight – an USFDA warning letter

PharmaWhiz Author November 24, 2019 Quality Oversight – an USFDA warning letter2020-07-08T11:02:54+00:00 Good Manufacturing Practices 10 Comments
Food and Drug Administration issued a warning letter to the Chinese Drug Manufacturing facility where Inspector found Oversight concerning the Quality. There are numbers of pharmaceutical industries received FDA 483s…
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Media fill aseptic processing

PharmaWhiz Author October 1, 2019 Media fill aseptic processing2020-06-14T09:29:18+00:00 Good Manufacturing Practices 6 Comments
A media fill aseptic processing is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures…
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How to implement Good Documentation Practices

PharmaWhiz Author August 7, 2019 How to implement Good Documentation Practices2020-06-14T09:27:13+00:00 Good Documentation Practices 2 Comments
In a pharmaceutical or healthcare GMP environment, implementation of Good documentation practices is very much required as it is directly affecting the product quality, safety, efficacy. If any document related…
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HPLC Troubleshooting & Its Data Integrity Assessment

PharmaWhiz Author February 12, 2019 HPLC Troubleshooting & Its Data Integrity Assessment2020-06-14T09:23:58+00:00 Good Laboratory Practices 2 Comments
HPLC (High Performance Liquid Chromatography) is a chromatographic technique used to separate a mixture of compounds between Mobile phase and stationary phase. The technique is widely used in industrial area…
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