The purified water is prepared by purified water generation system (Reverse Osmosis System) and collected in purified water storage tank of required capacity and distributed by a centrifugal pump for loop recirculation.
Steps for Analytical Method Development
Analytical methods in chemistry context entail how chemical components in natural materials or synthetic materials are identified, separated and then quantified. Analytical method development is a process whose main purpose is to prove if any analytical method in the pharmaceutical industry is suitable to be used in the measurement of API.
Organogram and Job Responsibilities in Pharmaceuticals
An organogram is a diagrammatic representation of any organization or company. It contains all the positions of all departments in the company. In other words, an organogram shows the relationship between all the employees of the organization.
Relative Response Factor (RRF) and its Calculation in HPLC Analysis
During the manufacturing process of active pharmaceutical ingredients, some unwanted substances are produced those are known as impurities. Some impurities are raised due to the degradation of the actual drug.
How to Remove Pathogens from Water Systems
Pathogens are the microorganisms which are capable the cause disease. All of these microorganisms are harmful to human. Those can survive into the purified water as well as the water for injection. The pathogenic bacteria found in water system are E.coli, Salmonella and Pseudomanas.
CAPA and Its Proper Implementation
When we are sick, we always trust the medical product believing that they will certainly provide relief. We get assured that the medical care we receive is not faulty. It is so fortunate that failure is not frequently experienced in medical devices and healthcare. Oftenly failure can occur, and the investigation is carried out to explain the reasons why it occurred.
How Pharmaceutical Companies Can Prevent Drug Recalls
Accidents happen. Even with a range of measures in place, we’ll likely always see drug recalls that cost companies a lot of money. However, that’s not to say that pharmaceutical companies aren’t in a good position to reduce how many drug recalls they have.
Data Integrity in Microbial Analysis
Data integrity in microbial analysis refers to the maintaining and assuring the accuracy of the data that is being obtained from the raw information. Microbiological laboratories handle a lot of important data. In most of the occasions, those are the mix of quantitative as well as the qualitative data. Though protecting the pharmaceutical microbial data against vulnerability is much more importan…
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.
FDA Warning Letters for Cleaning Validation
Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA GMP inspections.
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 …
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 …
Computerized System Validation Planning and Execution
Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Computer Validation Report as documented assurance that all activities required to validate the computerized system have been successfully completed.
7 Steps for Monitoring Compliance in Pharmaceuticals
Pharmaceutical manufacturing industry is a highly regulated industry that is regulated by different regulatory agencies from drug development to manufacturing and marketing. To ensure the compliance with all regulatory norms, pharmaceutical company needs to have a well-established monitoring system. In this article we understand the key step to monitor the compliance.
Role of Lubricants in Tablets
Lubricants are added to solid tablets and capsules to prevent the sticking of material to the punch, dies and compression machine during manufacturing. It allows the tablet to remove easily from the dies. Lubricants also stop the tablets from sticking to each other when stored in bulk form.
Difference between FDA 483 and Warning Letters
FDA inspects pharmaceutical manufacturing facilities to find cGMP violations. The observations are documented in form 483. If these observations are not fixed within the given timeframe by the company, the FDA may send them a warning letter.
Trends in GMP Violations in Pharmaceuticals
All pharmaceutical companies have established strict guidelines and regulations according to current good manufacturing (cGMP) guidelines. These guidelines help the manufacturers to ensure the quality of manufactured pharmaceutical products. Despite these efforts by the companies, there are a lot of issues found during regulatory inspections. This article will explore some of the most common GMP …
Guidelines for Drug Master File Submission
1. Meaning of a Drug Master File
DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers.
DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers.
Tips for a Successful FDA Inspection in Pharmaceuticals
It is the responsibility of the FDA to ensure that pharmaceutical products are safe and effective. To ensure this, the FDA inspects the pharmaceutical manufacturing facilities. This inspection of pharmaceutical manufacturing facilities is known as regulatory inspection. There are some important things to remember in the preparation of FDA inspection. In this article, we will share the same tips t…
Indian Govt releases guidelines on Pharmaceutical Marketing
Indian government published the latest guidelines to prevent unethical pharmaceutical industry practices that can influence healthcare professionals. Foreign tours in the name of medical education workshops and grants for research are not allowed now. This will help to gain transparency in the medical field.
Risk Assessment for the Purified Water System in Pharmaceuticals
The risk assessment is the process that helps to identify the risks associated with the process or system. Risk assessment is important for all pharmaceutical systems to know the potential risks for the product and the patients. In this article, we will discuss the risk assessment process for purified water system in pharmaceutical industry.
4 Steps to Effective Change Control in Pharmaceuticals
The pharmaceutical industry is the most impactful industry for human beings because it has direct impact on people’s lives. But the pharmaceutical industry is also a business and the personnel working in pharmaceutical industry can make errors like any other industries. These human errors can lead to serious consequences for patients and workers. To prevent these problems from happening, a good c…
Event Tree Analysis (ETA) in Pharmaceuticals
Event tree analysis (ETA) is a risk assessment technique that is used to sequence of events in a variety of industries. In pharmaceutical industry ETA is widely used to determine the root cause of any event. In this article, we will understand the uses of event tree analysis in pharmaceutical industry.
Tablet Defects in Pharmaceutical Manufacturing
Defected tablets are the most common problem in pharmaceutical manufacturing. These defects may occur in any stage of manufacturing from raw material to final product packaging. The defects may occur due to any human error, equipment malfunction or any environmental factor. In this article, we will focus on tablet defects that occur during manufacturing.
The Stratified Sampling Approach in Process Validation
Pharmaceutical manufacturing is a perfectly systematic process that primarily relies on quality control to produce quality products. The goal of quality control is to reduce batch failures and defects during manufacturing by taking steps at every manufacturing stage. Therefore, the sampling of the intermediate and final products is very important. One more considerable approach to validate the ma…
Contamination Control Strategies for Manufacturing Area
Contamination is a very serious issue in pharmaceutical manufacturing especially in sterile manufacturing. It is important to control the contamination in the pharmaceutical manufacturing area to protect the product. There are many ways of contamination so there are different strategies to control it. This article provides some strategies to control contamination in pharmaceutical production.
New Drug Application (NDA)
New Drug Application (NDA) are the documents about the product you want to manufacture and those are submitted to the government to detail the product and its usage. This document may take months to years to be approved, so it is important to submit the correct NDA for approval.
Case Studies: Troubleshooting Purified Water System Failures
Purified water in the pharmaceutical industry is a critical component because it is used at various stages of pharmaceutical manufacturing. There are many cases of water system failure in pharmaceutical industries that can be a cause of quality-compromised products. In this article, we shall discuss two different case studies of water system failures in the pharmaceutical industry.
Cleaning Validation of Clean-in-Place (CIP) Systems
The clean-in-place cleaning method is used to clean equipment that can not be disassembled or displaced like pipelines, tanks and large vessels. Cleaning validation ensures that our cleaning method is capable of removing the residues and contaminants from the equipment or vessel. Cleaning validation of such equipment as great importance because we can not move them for proper cleaning and some pa…
Regulatory Requirements and Guidelines for Cleaning Validation
Cleaning validation is an important part of pharmaceutical manufacturing and regulatory agencies take it very seriously. FDA issues many warning letters due to improper cleaning of facilities and equipment in various pharmaceutical manufacturing firms every year. Cleaning validation helps to ensure cleanliness to prevent cross-contamination to maintain product quality.
Enhancing Efficiency and Quality: Implementing Lean Manufacturing Principles in Pharmaceutical Manufacturing
In pharmaceutical manufacturing product quality, efficiency and regulatory compliance have important roles. To maintain product quality and use manpower efficiently, lean manufacturing principles play an important role. Lean manufacturing principles can help to optimize manufacturing operations, reduce manufacturing costs and improve product quality while maintaining regulatory compliance. In thi…
