Drug Master File (DMF): FDA Guidelines
A Drug master file is a submission form, that is required to submit to the Food and Drug Administration (FDA). …
A Drug master file is a submission form, that is required to submit to the Food and Drug Administration (FDA). …
Below learn about the List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy) and the …
Schedule M was incorporated by the Drug and cosmetic act of 1940 in 1988. Schedule M is also known for …
Batch manufacturing records (BMR) are an essential part of pharmaceutical manufacturing as they document the entire process of production and …
In Industries, we always face confusion about the “Usage of expired Raw Materials” and “Retesting of expired raw materials” in …
SAT is an inspection at the user’s site after machine/instrument delivery. opposite to SAT, the Factory acceptance test is a …
The airlocks is a transition space that typically has two doors in series to separate controlled environments such as a …
In today’s Pharmaceutical industries, the Granulation Technique is highly employed to get better Quality granules. Granulation is the act or …
Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO CleanRoom Classification through …
Due to the growing demand for GMP and regulatory requirements in the pharmaceutical industry, there is a high chance of …
Change control is Managing to control a change in a process/procedure/system through proper and scientific justification, review, approval, implementation, follow-up, …
Most pharmaceutical manufacturing companies have realized that in order to achieve the goal of long-term business survival in today’s regulated …
Before beginning an on-site audit, the following Check List for Visitors points should be considered: Using the WHO-GMP Document Checklist …
Six Sigma is an extremely disciplined activity that focuses on growing and giving close to excellent products and services. Six …
Good manufacturing practice and current good manufacturing practice are both terms correlated with each other. Both GMP and cGMP same …
Recall and complaints both are different things that are used for marketed products. Recall means a company’s removal and correction …