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…
Disinfectant validation and its significance in pharmaceutical industries
There are number of products that are recalled from the market just because of the contamination issue. Now, here are more Question come into mind; Where did it contamination came from ?…
How to prepare User Requirement Specification
URS mean User Requirement Specification is a first document to define the procedure for the procurement of any equipment. Generally people make lot of mistake during preparation of user requirement…
SOP on handling of Regulatory Audit
From the business point of view every regulatory audit is important for any pharmaceutical facility and handling of regulatory audit is an art and its required lots of preparation so…
Process alarm and Its significance during pharmaceutical product manufacturing
Process alarm is those alarms which are generally generated during any processing like manufacturing, packaging, utility operation and each alarm generate with some reason which has some significance on the…
Common Mistakes during Investigation of failure
Definitely you have encountered anytime with failure and you have done the investigation. If you see the FDA 483 and MHRA observation then you will find most of the observations…
Electronic Batch Record in Pharmaceutical and Its benefits
Since beginning Pharmaceutical & Biotechnology industries have a stringent or strict rule and regulation than other industries and day by day it becomes more strict as products which are manufactured…
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)…