ERP VALIDATION IN PHARMA
CORPORATE QUALITY ASSURANCE (CQA) SOP IN PHARMA
In general, large companies with multiple sites have one site that serves as “headquarters” for the corporation. It’s the place where (irrespective of any other activities) corporate executives work, and in most cases direct the activities of the subsidiary venues. Each of those ancillary locations will likely have its management team that answers to the […]
DECODING PHARMA
GTP IN QC CHEMICAL
JOB DESCRIPTION IN PHARMA
QUALITY CONTROL SPECIFICATIONS OF RAW MATERIALS
QUALIFICATION OF IPQC INSTRUMENTS
GTP FOR MICROBIOLOGY
USER REQUIREMENT SPECIFICATION FOR INJECTABLE
The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the validation process, typically before the system is created. They are written by the system owner and end-users, with input from Quality Assurance.
STABILITY IN PHARMA
Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity.
