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…
ALCOA Principles of Data Integrity
Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious consequences. Data integrity is defined as maintenance and assurance of data consistency and accuracy throughout its life-cycle. Keeping data consistent (unchanged from the very start to the end) is also a matter of data security and even though data integri…
Quality Inspection in Pharmaceuticals
In pharmaceuticals, quality inspection involves a complete assessment and testing of medicinal products to ensure that they meet the required standards. It involves a number of actions taken place as discussed here.
30 Common Ways to Avoid the Most Frequent GMP Errors
Most of the 483s and warning letters are issued because of common GMP errors. Below I have described common mistakes (and ways to avoid them) that I have seen and that many managers, supervisors, and executives have told me they have seen. Many common good manufacturing practice errors in pharmaceuticals can be easily avoided by following a few simple rules.
Reynolds Number and Its Significance in Purified Water System
Purified water is commonly used in the pharmaceutical industry, science laboratories, laser cutting and automotive use. Purified water finds a considerable amount of usage in the pharmaceutical industry in the form of raw material, component and solvent in the production of a number of medications.
Types of Purified Water Systems in Pharmaceuticals
One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation in many pharmaceutical procedures. Special care and attention must, therefore, be taken to ensure that the water used, meets the standard quality for purified water. Water is purified to remove impurities and prevent microbes which might cause contamination o…
How to Write a Factory Acceptance Test FAT Protocol
Factory Acceptance Test (FAT) is done at the equipment manufacturing site of the vendor before the shipping. A proper FAT can help to minimize the problems occur during the installation of the equipment at the site. A FAT protocol can be written as follows.
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…
Sanitization of RO Membranes in Purified Water System
The main ingredient in most of the pharmaceutical products used by people is water. Given the ever-increasing concerns about the ingredients used to make pharmaceutical products, it is important to ensure that the water used is stable and consistent.
Checks Before and After Installation of HVAC System
HVAC system provides a safe and controlled environment for pharmaceutical manufacturing because most of the pharmaceutical drugs are temperature and humidity sensitive. It also helps to maintain the classified area by controlling the dust particles and microbial load.
Importance of Microbiological Analysis in Cleaning Method Validation
Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times during manufacturing and processing of pharmaceutical products, active residues are left on the equipment and it may cause contamination of the next product to be processed in the same equipment.
Top 5 Tips for a FDA Inspection
It is being difficult to handle an FDA audit these days because a lot of warning letters are being issued to different pharmaceutical companies. Following are some tips to handle the FDA inspection properly.
Criteria for Selection of Clean Room Garments in Pharmaceuticals
A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals so as to ensure the quality of the products produced is not only achieved but also maintained. In order to achieve such a sterile environment, the products, as well as clothing that enter the GMP clean room, should be of the highest quality to prevent bringi…
Biocontamination Control Techniques for Purified Water System
Water treatment, storage and distribution system for preparation and distribution of purified water should have the properties to control microbiological contamination. Techniques should be employed during the qualification of water system.
Factory Acceptance Test - FAT
Any equipment that is being intended to be used in producing various products has to meet certain specifications before it is delivered to a purchaser and installed. The equipment has to undergo what is called the Factory Acceptance Test (FAT) so as to ensure its proven quality and compliance. These tests play a vital role in ensuring guaranteed quality product.
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.
