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Pharmaceutical Guidelines

Jun 18, 2017

Duct Designing in HVAC System

Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill.
Jun 11, 2017

Problems Associated with Pharmaceutical Cleanroom Areas

Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to a number of reasons. Human being plays a significant role in producing this contamination through vital body organs such as the skin.
Jun 4, 2017

Sampling in Cleaning Validation in Pharmaceutical Industry

Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). Such as, FDA inspectors now expect to see a functioning cleaning validation program with appropriate documentation in place during their inspections.
May 28, 2017

Possibilities of Contamination in Sterile Products

In pharmaceutical production, the term "sterile products" is usually used to describe parenteral preparations. These are products which are not meant to be administered via oral route or alimentary canal, so do not benefit from the protection of the immune system which the alimentary canal provides. Administration of these drugs is done directly to the blood stream or various body tissues.
May 21, 2017

ALCOA in Pharmaceuticals : A necessary tool for Quality

Any pharmaceutical product has to undergo a process before it can be used by the public. This process ensures that the product is safe for everyone. And if there are any side-effects of the product, the consumer can be warned about them beforehand. This helps to decide for whom the product would be suitable.
May 14, 2017

Controlled area in Sterile Pharmaceutical Manufacturing

A controlled (classified) area is an enclosed environment or room with a flawless control over particulate contamination. More specifically, the areas have a controlled contamination level, which is specified regarding the number of particles for every cubic meter, for a specified particle size. The restricted areas are constructed with impeccable humidity, temperature and pressure control to minimize the generation, introduction, and retention of particulate matter inside the rooms.
May 7, 2017

Basics of HVAC System

Air conditioning has changed over years, HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Heating, Ventilation and Air Conditioning is a system that is used to control the air temperature by controlling the air filtration and the moisture in the air. 
May 1, 2017

Importance of Negative and Positive Controls in Microbial Analysis

In microbiology, there two types of test controls, the positive and the negative control. The positive control is an experiment that involves the repetition of the test using working treatment. It is a duplicate experiment which helps the analyst confirms the correctness of the results of a particular test.
Apr 25, 2017

Critical and Non-critical Areas in Pharmaceutical Manufacturing

Appropriate design, positioning and use of critical and non-critical areas in the pharmaceutical manufacturing process are among the key prerequisites for success in this industry. Critical areas include all areas in which any kind of sterile product (including both drugs and equipment) must be exposed to the sterile environment and where activities including sterilization, sterile filling and closing take place.
Apr 16, 2017

Various Types of Blenders and Their Purpose

A blender is a very important equipment in the pharmaceutical industry, as a medicine is manufactured by mixing a number of drugs and chemicals. This mixing is required to be undertaken in either dry or wet state depending upon the chemical composition and the reactions allowed. There are various types of blenders available in the industry, each one having its own purpose. Some of them are discussed in subsequent paragraphs.
Apr 9, 2017

Performance Qualification (PQ) of Pharmaceutical Equipment

When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
Apr 2, 2017

Operational Qualification (OQ) in Pharmaceuticals

Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
Mar 26, 2017

Concept of GAMP 5 in Pharmaceuticals

Good Automated Manufacturing Practice denoted as GAMP, are guidelines provided for both users of automated pharmaceutical products and manufacturers of these products. GAMP was founded in 1991 by pharmaceutical industry professions in the UK with the aim of addressing the needs of the industry and basically to improve the changing expectations of Europe regulatory agencies and it mainly wanted to provide understanding on how pharmaceutical companies should validate their computer systems.
Mar 19, 2017

Installation Qualification (IQ) in Pharmaceuticals

Installation Qualification (IQ) is ascertaining that all the important aspects of process equipment together with ancillary system installation follow the approved specification of a manufacturer and what the supplier recommends. An equipment has to be installed by trained personnel according to the drawings and specifications provided. An approved protocol designed by an engineering department is used for performing an IQ. All procedures to do with maintenance, cleaning and calibration are drawn at the installation stage.
Mar 13, 2017

Design Qualification (DQ) of Equipment

Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceuticals and manufacturing practices. However, the procedure for design qualification in pharmaceuticals is one reason as to why some products do not make it to the shelves in drugstores.
Mar 5, 2017

Top 10 General Interview Questions and Answers

Your answers to the questions asked in the interview directly affect your selection for the job. Everyone prepares for the job interview and tries to find the question those could be asked in his interview. Some questions are very common those are asked by the interviewers.