Archives for Good Manufacturing Practices
Trend Analysis a tools for Risk-Based thinking
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…
5 ways to reduce Human Error
"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 Analysis of MHRA 2018 GMP Inspection’s Deficiencies
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…
Quality Oversight – an USFDA warning letter
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…
Media fill aseptic processing
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…
Handling of consumables in pharmaceutical industries
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…
SOP on Technology Transfer
SOP ON TECHNOLOGY TRANSFER The objective of this procedure is to provide a guideline on the transfer of technology from R&D to the manufacturing site and from one manufacturing site…
Microbial Contamination in Pharmaceutical products
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…
Raw Material Supplier Selection And Qualification in Pharmaceutical
In pharmaceutical raw materials supplier selection and qualification is a lengthy but essential process for any pharmaceutical products. Each and every raw materials (excipients, Active pharmaceutical ingredients , preservative)…
Sampling of Raw Material used in the Pharmaceutical Drug Product Preparation
Each of the raw material used in the preparation of pharmaceutical drug products plays a vital role as it directly affects the quality of final drug product so in…