Oct 28, 2024
Principle and Working of Autoclave
›
Sterilization is critical within the pharmaceutical and medical industries. From direct patient care to laboratory work, huge numbers of ins...
1 comment
Oct 22, 2024
Air Handling Unit and Its Working Process
›
Air handling in pharmaceutical manufacturing is important to maintain the safety and quality of the products. In this article, we shall unde...
Oct 16, 2024
Regulatory Guidelines on Data Integrity
›
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...
Oct 15, 2024
Identification of Worst Case in Cleaning Validation
›
It is not possible to carry out cleaning validation of all products manufactured in the facility. Therefore, products are selected on the ba...
Oct 14, 2024
Importance of Data Integrity in Pharmaceuticals
›
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, l...
Oct 7, 2024
Different Stages of Tablet Manufacturing Process
›
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...
Sep 27, 2024
Purified Water System Validation
›
Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term cont...
Sep 25, 2024
Procedure for Sampling in Process Validation
›
Sampling plays a major role in achieving the accurate results of the analysis. Sampling plan and procedure must be defined in validation ...
Sep 24, 2024
Validation of Clean Room Pass Boxes
›
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 ...
Sep 20, 2024
5 Steps of FDA Approvals
›
Medicines are not food and those are taken by unhealthy individuals. Therefore, the safety and efficacy of the drug product are a primary re...
Sep 18, 2024
FDA New Data Integrity Guidelines: Highlights
›
Recently FDA observed a lot of cGMP violation in pharmaceutical manufacturing facilities worldwide. Most of the violations are related to da...
Sep 16, 2024
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 pr...
Sep 11, 2024
Requirements of FDA for Training in Pharmaceuticals
›
The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR require...
Sep 5, 2024
Validation Program in Pharmaceutical Industries
›
Validation is defined as: Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or a...
Sep 4, 2024
Tips to Develop Equipment Cleaning Procedure
›
A well-developed cleaning method is a primary requirement for the cleaning validation . Cleaning procedure should be developed before sta...
Sep 3, 2024
Basics of Cleaning Validation
›
Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufa...
Aug 30, 2024
Validation of Utility Systems in Pharmaceutical Facilities
›
This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as ...
Aug 29, 2024
Low Temperature Sterilization Process (115°C) and Its Validation
›
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...
Aug 28, 2024
Basic Requirements for Process Validation Exercise
›
Every pharmaceutical plant has got a prime objective of manufacturing products of required attributes and quality in a consistent manner, at...
Aug 27, 2024
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 p...
Aug 26, 2024
Epoxy Flooring and Its Benefits in Pharmaceuticals
›
The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating mus...
Aug 23, 2024
Equipment Lubricants Used in Pharmaceuticals
›
Lubricants are used to minimize the faction between the moving surfaces of the machines. The fraction may cause the heating of the moving...
Aug 22, 2024
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 ...
Aug 21, 2024
How to Care for pH Meter Electrodes
›
pH meter electrodes measure the degree of acidity by comparing the aqueous solutions. The electrodes are immersed in with the reference half...
Aug 9, 2024
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 betwee...
Aug 8, 2024
Sanitation of Cleanroom Area in Pharmaceutical Manufacturing
›
It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. The area should be clean a...
Aug 7, 2024
Activated Carbon Filter and Increase in Efficiency for Water System
›
The activated carbon filter is used to remove chlorine and organic matter from the water. It also removes the color and odor from the wat...
Aug 6, 2024
Biofilm Removal and Chemical Sanitization of RO Systems
›
To control microbial growth, RO systems must be chemically sanitized on a regular basis. Prior to sanitation , it is important to chemica...
Aug 1, 2024
Planning and Procedure followed During Regulatory Audits
›
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically...
Jul 31, 2024
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 chemic...