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.
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…
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 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.
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.
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.
Process Validation in Pharmaceutical Manufacturing
1. IntroductionProcess validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance program associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These principles are as follows: • Quality, safety and efficacy must b…
User Requirement Specification (URS) of Equipments
User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by the equipment user department. It is sent to equipment manufacturer to make it as desired criteria.
Why Cold Chain Logistics are Required in Pharmaceuticals?
Over the years the pharmaceutical industry has used non-temperature specific drugs as pills for most of its purposes. Cold chain pharmaceutical logistics, however, for much of the decades, has been associated heavily with the food industry and less with the pharmaceutics. The introduction of new types of medicines, time and temperature dependent, has seen the adoption and wide consumption of cold…
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.
Mode of Action of Disinfectant Solutions
A lot of disinfectants are used for sanitization and disinfection in pharmaceutical industries. These have different antimicrobial properties based on their mode of action. Disinfectants having a different mode of actions are helpful to prevent the development of the resistance in microbes.
Validation of Compressed Air
Compressed air is used in the different areas of the pharmaceutical manufacturing facility. Compressed air may contain contaminants those may cause contamination in the pharmaceutical products. Therefore validation of compressed air is necessary to produce quality products.
Three Consecutive Batches for Validation in Pharmaceuticals
This is a common concept to validate three consecutive batches in pharmaceuticals. In process validation, initial three batches are taken for validation. This is a basic question that concentrates everyone’s mind that why three batches are taken for validation?
Qualification Procedure for Vial Washing Machine
Sterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before filling. Automatic vial washing machines are used to clean but the process of cleaning of the vials should be validated. The efficiency of these machines is verified by following tests.
HPLC System Software Validation Plan
Introduction
Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in different HPLC systems. All softwares are required to validate to ensure the accuracy of the produced data.
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
NOEL and MACO Calculations in Cleaning Validation
NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined
to calculate the MACO (Maximum Allowable Carry Over) in cleaning validation. NOEL
is the amount of drug in mg that does not have any effect on the human health.
Purpose of Process Validation in Pharmaceuticals
The kind of effort expended for Process Validation is largely determined by organizational structure. Whether Process Validation is managed by a department, a consultant, or a committee, the criteria for the program are still the same. These criteria will be examined by the responsible individuals so that the program will be tailored to the character of the process under study. The following ques…
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.
Sampling in Cleaning Validation in Pharmaceutical Industry
Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). Such as, FDA inspectors now expe…
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…
Importance of Validation in Pharmaceuticals
Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is a very common concept in the pharmaceutical industries throughout the world.
Regulatory Expectations from Cleaning Validation
Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product if it is not cleaned properly. Improperly cleaned manufacturing equipment is a major source of cross-contamination. Regulatory agencies are more concerned about the cross-contamination of penicillin with non-penicillin products.
How to Effectively Execute a Validation Protocol?
Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
How to Write a Validation Master Plan?
A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline on how to achieve and then maintain a qualified facility. VMP is basically a summary of the validation strategy. It is a crucial segment of Good Manufacturing Practi…
Revalidation of Equipment and Process in Pharmaceuticals
Revalidation in the pharmaceutical industry is very important as it helps to maintain the validated status of the equipment, plant, manufacturing process as well as the computer systems. This procedure is necessary for periodic checking of the validation results according to the revalidation period.
Alarm Challenge Test in Pharmaceuticals
The alarm challenge test in pharmaceuticals is very important as it ensures that everything is in working order, hence preventing accidents and other hazards. Safety concerns take the front seat in pharmaceuticals, in large part because the industry deals with the manufacture of medicines consumed by patients. The alarm challenge test in pharmaceuticals is intended to ensure that the systems and…
Steps for HPLC Method Validation
In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the assay method to provide useful data to ensure that the process or the technique gives satisfacto…
Design Qualification (DQ) of Equipment
Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceuticals and manufacturing practices. However, the procedure for design qualification in pharmaceuticals is one reason as to why some products do not make it to the shelves in drugstores.
Performance Qualification (PQ) of Pharmaceutical Equipment
When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
Operational Qualification (OQ) in Pharmaceuticals
Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
