This article is helpful to understand the terminology of addendum, errata, attachment, format, annexure, exhibit, amendment, corrigendum. These all concepts are used in the pharmaceutical industry.

This case study is based on the belt speed verification test of depyrogenation tunnel. Belt Speed test failed during operational qualification. We will see how to rectify, investigate this deviation/nonconformance. Description of deviation During operation qualification of depyrogenation tunnel third party found that conveyor belt speed verification test is fail…

This article contains definition of Pharmacovigilance and Adverse Event, Importance of Pharmacovigilance, how to report Adverse event, Content of adverse report form and Main task of pharmacovigilance in pharmaceutical. 1.0 Definition of Pharmacovigilance As per WHO Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention…

SOP for Annual product quality review (APQR/APR) which is the best tool in pharmaceuticals for identification of the process/method consistency, the need for product/process, and method improvement. …

This SOP is applicable for the microbiology laboratory to achieve accuracy in the microbiological results. Mainly Bacterial Endotoxin Test (BET) and sterility / Bio Burden tests are performed in the microbiology lab. 1.0 Bacterial Endotoxin Test (BET) 1.1 Always check the cleaning status of the LAF and working area of…

The root cause is the very common procedure adopted by most of the industry to identify the issue/problem. Most of the industry follow the standard procedure to identify the root cause. Some of the common tools are used to identify the root cause. These tools are the way to identify…

Data integrity is a very popular concept in the pharmaceutical industry. All regulatory bodies required authentic, accurate, complete and trustworthy data. FDA’s general requirement is that, keep data in an unaltered and secure manner. So, the pharmaceutical industry secures its data in such a way that data should be unaltered…

Good laboratory practices need to be performed in the laboratory for consistent, reliable analytical results. This SOP introducing about Good Laboratory Practices (GLP) guidelines (USFDA), Examples of Good laboratory Practices (GLP), Good Laboratory Practices principles, Rounding rules, Schedule L1 requirements. Good laboratory Practices is quality standard practices which follow in…

Standard operating procedure on Site Master File (SMF) is describes, What is a site master file and what are the requirements of the regulatory bodies while preparation of the site master file. 1.0 PURPOSE: Purpose of this SOP to provide a procedure for preparation and updation of Site Master File…