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Handling Static Charge in Pharmaceutical Manufacturing

Static charge is the electric current developed by the rubbing of moving parts of equipment or contact and separation of material particles. It is generated in different pharmaceutical manufacturing equipment during processing. Sometimes it is generated by the continuous flow of the powder on the equipment surface.

Fishbone Tool of Investigation in Pharmaceuticals

Fishbone diagrams, also known as Ishikawa fishbone diagrams, is a visual form of cause and effect diagram which can help analyze the root causes of a problem. It allows the audience to brainstorm the reasons which might otherwise be directly ignored. These causal diagrams have been in use since 1968 to find root-cause analysis of a specific event. 

Different Types of HPLC Columns Used in Analysis

Columns are the main component in HPLC because the column is responsible for the separation of the sample components. The sample passes through the column with the mobile phase and separates in its components when it comes out from the column.

Planning and Execution of Internal Audits in Pharmaceuticals

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 effective and efficient, a good audit plan is compulsory. Internal Audits can be a valuable tool for any company for information collection and assessment of daily performance.

Airlocks and Change Rooms in cGMP Facility

A pharmaceutical GMP (Good Manufacturing Practices) facility has to be designed to minimize the risks involved in the pharmaceutical production those cannot be avoided through testing the final product. There is a protocol to follow the GMP system which ensures that the products are consistently produced and controlled according to quality standards.

How Effectively Execute a Validation Protocol?

Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.

What does Inspector Look for during FDA Inspection?

FDA inspections in pharmaceutical manufacturing units is being critical these days and it seems that it will be more critical in future because FDA is focusing more on product quality as well as its documentation.

Steps for HPLC Method Development

Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, used column, mobile phase and buffer should be common. It can be done easily step by step.

10 Tips for HPLC Analysis In Pharmaceuticals

HPLC, also known as High-Performance Liquid Chromatography system, is one of the most crucial analytical methods in pharmaceuticals. The purpose of HPLC is the separation of each compound that make up a mixture.

It passes pressurized liquid solvent with the use of pumps which holds the sample mixture via a column full of solid adsorbent substance. There is a difference in the flow rates for each …

Steps for HPLC Method Validation

In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the assay method to provide useful data to ensure that the process or the technique gives satisfacto…

FDA’s Top Data Integrity Issues Found During Inspections

Data integrity is the common issue that is found during the FDA inspections. When FDA finds any invalid or unreliable data during the inspection, it is considered by FDA that the quality of the products manufactured in such a manufacturing facility cannot be good. FDA issues warning letter when the violation of 21 CFR part 11 is found during the inspection.

Top 10 Tips for Sterility Test

Sterility is a critical test in sterile pharmaceutical manufacturing. there are a lot of chances of errors in this test due to the requirement of highly aseptic conditions during the process. The analyst must be careful about the contamination during the handling of the sample and sterile equipment.

Possible Causes of Out of Specification

Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the predefined limits for that particular product. There are various possibilities that may be responsible for these deviations.

How to Eliminate Microbial Contamination from Classified Area

We are receiving a lot of queries from pharmaceutical professionals that they have a lot of contamination in the classified areas. Contamination exceeds grade limits and they have tried everything but unable to get rid of it. Here we shall discuss the effective ways to remove the contamination from the classified areas.

How to Prepare for a FDA Inspection

Facing FDA inspection is being critical day by day because FDA is inspecting pharmaceutical units at very short notice period. This makes it critical because of having a short period of preparation. FDA is doing this because they want to develop a quality culture in pharmaceutical firms instead of a culture where quality is maintained before inspection.

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

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