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Temperature and Humidity Validation/Mapping in Storage Area

Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at a higher temperature, therefore, it important to validate the storage area for temperature.

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 t…

Media Fill Test Failure Investigation

Media fill test assures the sterility of the sterile manufacturing process. When any media fill test fails, it shows the contamination in the manufacturing system. This failure must be investigated.

Recovery Factor Determination in Cleaning Validation

It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical manufacturing equipment. Recovery factor is the recovery of swabbed material from the equipment to the solution.

Cleaning Validation of Pharmaceutical Equipment

The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous product. After the process, equipment used for manufacturing of the product shall be cleaned as mentioned in respective SOPs for cleaning.

Reduce Validation Cost in Pharmaceuticals

The traditional pharmaceutical validation process in the pharmaceutical industry is time-consuming and not very cost effective. There are various factors that can lead to increased costs and unnecessary delay in the validation. Some of these factors include inefficient analytical testing methods, an excessive number of approvals and personnel required to validate documents, repetition and rework.

Why Firms Must Avoid FDA 483 and Warning Letters?

FDA has the mandate of ensuring the safety of the public by assuring the safety of drugs and medical devices among others. To this end, FDA officials occasionally visit manufacturing establishments for the purpose of carrying out an inspection to find out whether or not the establishment is in compliance.


What Does Quality Really Mean for Pharmaceuticals?

Pharmaceutical companies are an important part of the medical field. They play a significant role for everyone involved, such as the producer, the doctor who prescribes and the consumer who is the patient. The pharmaceutical industry has been in existence for several years now and is considered to be a key industry in the medical field.

Quality System in Pharmaceuticals

Quality System in Pharmaceuticals or other words quality assurance is a dynamic process of understanding the regulations in this industry. The drugs that are taken to the consumers need to be safe and not cause long term effects on the one taking them.

Fault Tree Analysis for Investigation

The fault tree is an investigation tool to identify and resolve the defects in any system or process. It is also helpful to find the root cause of any event. An organization or company may have more than one fault trees based on their defects, errors or problems.

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.

5 Why Tool for Root Cause Analysis in Pharmaceuticals

Root cause analysis is done to determine the main cause of the error or problem caused during the process. The root cause for the out of specification, deviations during manufacturing and market complaints must be determined. Different methods are used for root cause analysis in pharmaceuticals.

ALCOA and ALCOA Plus Principles for Data Integrity

The term ALCOA is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA was then expanded to ALCOA Plus (ALCOA+), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.

Difference between C8 and C18 Columns Used in HPLC System

High Performance Liquid Chromatography system (HPLC) refers to a technique in analytical chemistry that is used to identify, separate and quantify each component in a mixture. C8 and C18 both refer to the alkyl chain of a bonded face of a column. They are both used in the high performance liquid chromatography system. The two columns have some similarities, but they are also different in some way…

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.

Purified Water Storage and Distribution System

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 …

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.


About the Author




Ankur Choudhary is experienced in pharmaceutical, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008.
Email: info@pharmaguideline.com

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