Pharmaguideline

UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in puri...

Media  fill test is done to verify the sterility of the sterile manufacturing process. Media fill validation for sterile API is differen...

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specificat...

Standard operating procedures are back bone of a pharmaceutical manufacturing company. These are essential to produce effective and quality ...

Cleaning is an important part of pharmaceutical manufacturing to manufacture contamination-free quality products. Facility cleaning and sani...

Analytical method validation is documented evidence that any analytical method used for the analysis of any product is suitable, reliable an...

Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage ...

Film Coating Process Film coating process plays a very important role in film coating and a number of problems in tablet coating are relat...

Sterilization is critical within the pharmaceutical and medical industries. From direct patient care to laboratory work, huge numbers of ins...

Air handling in pharmaceutical manufacturing is important to maintain the safety and quality of the products. In this article, we shall unde...

The pharmaceutical industry has been on the public eye for a long time now. People all over the world depend on quality medicine, safe to us...

It is not possible to carry out cleaning validation of all products manufactured in the facility. Therefore, products are selected on the ba...

These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, l...

The tablet manufacturing process is a series of steps that are followed step by step to produce a quality product. All steps have their uniq...

Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term cont...

Sampling plays a major role in achieving the accurate results of the analysis. Sampling plan and procedure must be defined in validation ...

A pass box which is also called a hatch is an equipment which is used to transfer pharmaceutical material from an area of lower cleanliness ...

Medicines are not food and those are taken by unhealthy individuals. Therefore, the safety and efficacy of the drug product are a primary re...

Recently FDA observed a lot of cGMP violation in pharmaceutical manufacturing facilities worldwide. Most of the violations are related to da...

Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the pr...

The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR require...

Validation is defined as: Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or a...

A well-developed cleaning method is a primary requirement for the cleaning validation . Cleaning procedure should be developed before sta...

Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufa...

This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as ...

Sterilization of the media and material is generally done at 121 °C but sometimes it is required to do at low temperature (115 °C) becau...

Every pharmaceutical plant has got a prime objective of manufacturing products of required attributes and quality in a consistent manner, at...

Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any p...

The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating mus...

Lubricants are used to minimize the faction between the moving surfaces of the machines. The fraction may cause the heating of the moving...