Pharmaguideline

1.0 OBJECTIVE 1.1  To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification ...

NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined to calculate the MACO (Maximum Allowable Carry Over) in c...

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

1. Introduction Validation is an essential part of good manufacturing practices (GMP) . It is, therefore, an element of the quality as...

The kind of effort expended for Process Validation is largely determined by organizational structure. Whether Process Validation is mana...

HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture. In the HPLC techniqu...

In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of di...

HPLC detectors are used in the detection of the solute present in the eluent coming from the HPLC column . They are capable of determini...

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collect...

The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the...

There are different grades of stainless steel according to the composition like 302, 304, 304L, 316, 316L, 410, 430, 440 etc. but all are...

Sometimes during manufacturing, the in-process materials need to be held for a period more than usual. Hold time study during manufacturi...

Organizations engaged in the distribution, as well as the storage of materials along with products, should monitor, establish, maintain and ...

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

Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals...

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

Introduction Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in ...

Auditing in the pharmaceutical industry is an important tool to improve the efficiency and quality of products. It ensures the implementatio...

Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and ...

In any type of audit, the first and most important part is making a plan. In order to make the execution of audit of pharmaceutical effectiv...

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...

In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities giv...

Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by...

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

GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmace...

In 2016 FDA published a guidance “Pharmaceutical Manufacturing/Quality Standards Data Integrity and Compliance with cGMP” to highlight the d...

FDA recently published a guidance for manufacturers and suppliers of the glycols to spread awareness about the potential health risk. In ear...

The quantity of tablets used for coating in coating pan plays a great role in getting good coating results. The capacity of the coating mac...

Root Cause Analysis is the most important factor in determining the quality of each organization including the pharmaceutical industry, it i...

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...