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5 ways to reduce Human Error

PharmaWhiz Author February 8, 2020 5 ways to reduce Human Error2020-02-08T17:17:15+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…

Statistical Evaluation (Analysis) of MHRA 2018 GMP Inspection’s Deficiencies

PharmaWhiz Author January 8, 2020 Statistical Evaluation (Analysis) of MHRA 2018 GMP Inspection’s Deficiencies2020-01-09T15:31:52+00:00 Audit & Compliance 2 Comments

MHRA published its GMP Inspection Deficiency Data for year 2018. In totality MHRA Inspectorate audited 286 facilities across the globe in the year 2018 and made total 6209 deficiencies EU…

Quality Oversight – FDA warning letter

PharmaWhiz Author November 24, 2019 Quality Oversight – FDA warning letter2020-01-08T17:47:51+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…

Aseptic Process Simulation by Media Fill

PharmaWhiz Author October 1, 2019 Aseptic Process Simulation by Media Fill2020-01-19T15:39:42+00:00 Good Manufacturing Practices 6 Comments

A media fill 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 are adequate to…

How to implement Good Documentation Practices

PharmaWhiz Author August 7, 2019 How to implement Good Documentation Practices2020-01-08T17:48:50+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…

HPLC Troubleshooting & Its Data Integrity Assessment

PharmaWhiz Author February 12, 2019 HPLC Troubleshooting & Its Data Integrity Assessment2019-02-12T16:27:13+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…

Handling of consumables in pharmaceutical industries

PharmaWhiz Author December 11, 2018 Handling of consumables in pharmaceutical industries2019-11-24T17:51:06+00:00 Good Manufacturing Practices 4 Comments

If I am talking about material management system, we do all the thing to comply the regulatory requirement; Raw material supplier qualification, raw material technical evaluation, testing etc. but to…

Technology Transfer Procedure

PharmaWhiz Author December 11, 2018 Technology Transfer Procedure2019-09-01T12:32:43+00:00 Good Manufacturing Practices No Comment

PROCEDURE ON TECHNOLOGY TRANSFER Objective of this procedure is to provide a guideline on the transfer of technology from R&D to manufacturing site and from one manufacturing site to another manufacturing…

Microbial Contamination in Pharmaceutical products

PharmaWhiz Author December 10, 2018 Microbial Contamination in Pharmaceutical products2019-11-28T22:14:27+00:00 Good Manufacturing Practices 1 Comment

What is Microbes?The microorganism or microbes is a microscopic organism which may exist in single celled form or in a colony. Single celled microorganism were in the first form of…

Disinfectant validation and its significance in pharmaceutical industries

PharmaWhiz Author December 9, 2018 Disinfectant validation and its significance in pharmaceutical industries2020-01-03T14:53:13+00:00 Validation No Comment

There are number of products which are recalled from the market just because of contamination issue. Now, here are more Question come into mind; Where did it contamination came from ? How…