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Pharmaceutical Guidelines

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Gap Analysis for Regulatory Compliance

If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis.

Process Analytical Technology (PAT) in Pharmaceuticals

Process Analytical Technology is a system for designing, analyzing and controlling manufacturing processes through timely measurement during processing. With the goal of ensuring final product quality, it analyzes raw and in-process materials. The PAT is now being deployed in the pharmaceutical industry, where it is seen as a technology that can help companies to improve their conformity with ma…

Detergents Used for Cleaning of Pharmaceutical Equipments

There are different types of detergents such as anionic detergents, cationic detergents, amphoteric detergents, alkaline detergent etc. This nature of the detergent depends upon the nature of the surfactant found in the detergent. These all have their specific use due to their cleaning properties.

Quality by Design (QbD) in Pharmaceuticals

The term quality means the appropriateness for the intended use. In the field of pharmacy, quality refers to the state of being free from any contamination and ability to treat the disease intended for. The Quality of the pharmaceutical commodity can be assessed by in vivo or in vitro execution tests.

Cellulose Membrane Filters Used in Pharmaceuticals

Membrane filters are thin polymer films those have many microscopic pores. These filters have different pores sizes and used for different purposes accordingly. Membrane filters are used in various pharmaceutical activities. Cellulose filters are most commonly used filters in microbial analysis and reverse osmosis water systems. Most of the cellulose membrane filters are hydrophobic in nature.

Different Types of Temperature Sensors

Temperature sensors are used in different processes in pharmaceuticals. Different types of temperature sensors are used in different processes according to their accuracy needs.

Buffer Area and Its Maintenance in Sterile Facility

The buffer area is the sterile zones in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation facility is known as the buffer area. The buffer area is always ISO 7 area (class 10,000) or better air quality.

Different Types of Titrations

Titrimetry, or in more general terms titration is a process which is carried out to analyze an unknown compound in order to determine the concentrations of various substances present in it. It is a well-known method used in laboratories for the sole purpose of quantitative and qualitative estimation of a particular chemical substance.

Requirements and Maintenance of HVAC System in Manufacturing Facilities

Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper environmental condition in the manufacturing area. Therefore, environmental conditions of the manufacturi…

Steps to Minimize the Data Integrity Risk

Data security and has become a hot issue in pharmaceuticals over the past few years because FDA and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records. Recently FDA has published a guideline in the form of question and answer for the compliance of data integrity in firms. These documents clarify the expectations of the FDA from ph…

Working of a HVAC System and Its Functions

Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of good quality. It ensures that there are all the necessary favorable conditions for successful manufacturing. A basic working HVAC system works as explained below:
First, the system collects fresh air from outside the plant from where it is filtered using a fi…

Maintenance of Pharmaceutical Clean Area: FDA Recommendation

Maintenance of pharmaceutical clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area.

Difference Between HEPA and ULPA Filters

The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are designed to catch and remove tiny, airborne particulate matter such as bacteria, pollutants, and dust…

Isolators and Their Use in Sterile Manufacturing

An isolator can best be defined as an arrangement of physical barricades which are incorporated to a degree that the isolator is capable of being sealed; so as that it can undertake a scheduled leak tests that are based on pressure, to attain stated limits.

Restricted Access Barrier System (RABS) in Pharmaceuticals

The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms and useful in aseptic filling systems. RABS process in an ISO 5 environment, similar to isolators. RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and the int…

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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