Revalidation of any process is an essential part of the validation. It improves the quality of the product and increases the smoothness of the process. There are various conditions in which it is essential to revalidate the process. Revalidation is done in two conditions. A. Periodic Revalidation B. Revalidation after any change
Validation of the Effectiveness of UV Light in Water System
UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in purified water is kept at optimum, most of the time, validation of effective working of UV light in pharmaceutical water system needs to be carried out.
Media Fill Test for Sterile API Manufacturing Process
Media fill test is done to verify the sterility of the sterile manufacturing process. Media fill validation for sterile API is different from the sterile formulation media fill.
How to Write a Validation Protocol?
A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
Writing Effective SOPs in Pharmaceuticals
Standard operating procedures are back bone of a pharmaceutical manufacturing company. These are essential to produce effective and quality products consistently. But writing an effective, easy to understand and meeting the regulatory requirements SOP is not an easy task.
Detergents Used for Cleaning of Pharmaceutical Equipment
Cleaning is an important part of pharmaceutical manufacturing to manufacture contamination-free quality products. Facility cleaning and sanitization is an important part of GMP compliance. In this post, we will explore the importance and use of detergents used in the cleaning of pharmaceutical equipment used in manufacturing.
Why is Analytical Method Validation Required?
Analytical method validation is documented evidence that any analytical method used for the analysis of any product is suitable, reliable and produces consistent results. We can say that a validated analytical method produces reliable and authentic results.
Basics of HVAC System and Its Components
Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Maintenance of area and air quality by filtration and temperature and humidity is controlled by using an HVAC system.
Film Coating Process in Pharmaceuticals
Film Coating Process
Film coating process plays a very important role in film coating and a number of problems in tablet coating are related to process setup. There is a number of variables which should be controlled in a process and we will understand how these variables are crucial for the film coating process. We will also study various kinds of equipment, which are available for film coating…
Principle and Working of Autoclave
Sterilization is critical within the pharmaceutical and medical industries. From direct patient care to laboratory work, huge numbers of instruments, containers, and equipment are used each day. With each new surface comes the risk of contamination by spores, bacteria, viruses, or other dangerous microbes. How then, can pharmaceutical specialists ensure the cleanliness of their tools?
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 understand the working of air handling units in pharmaceuticals to produce safe and effective products.
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 use drugs and above all, those that are effective in curing the disease they are meant to cure.
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 basis of the worst case. Worst case is the condition when it is difficult to clean the residues of the manufactured product from the equipment surface.
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, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same…
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 unique processing and testing to proceed to the next step.
Purified Water System Validation
Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term control; and Phase III: long-term control.
The objective of pharmaceutical water system validation during these three phases should demonstrate that water system is under control and producing the specified quality of water over a long time period.
Related: Reverse…
The objective of pharmaceutical water system validation during these three phases should demonstrate that water system is under control and producing the specified quality of water over a long time period.
Related: Reverse…
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 protocols and training should be provided to the concerned staff before the validation activity starts.
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 to an area of higher cleanliness and vise-versa. They, therefore, work as a barrier between areas with different levels of cleanliness.
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 requirement while producing the medicines. Drug approval by the FDA is a critical process and has to follow different steps before any drug product reaches to the market. The following steps are followed by any company to get approval from the FDA to produce an…
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 data integrity. However 21 CFR part 211 and 212 explain the requirements of FDA data integrity but still, companies are facing problems in documentation and electronic record maintenance.
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 predefined limits for that particular product. There are various possibilities that may be responsible for these deviations.
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 requirements. The FDA GMP training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects.
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 assay will consistently produce the desired results according to predetermined specifications and quality attributes. Qualification is defined as:
The documented action of showing that any equipment works correctly and consistently leads to the expected results.
Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes. Qualification is defined as:
The documented action of showing that any equipment works correctly and consistently leads to the expected results.
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 starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
Basics of Cleaning Validation
Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.
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 a guideline for those involved in the validation of ABC Pharmaceutical. Approval of this Master Plan neither provides approval of these test functions and acceptance criteria nor does it limit the test functions and acceptance criteria included in any protoco…
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) because of heat sensitivity of the material. This sterilization below 121 °C is called Low-Temperature Sterilization.
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 the lowest possible cost. In order to maintain the quality of a drug product and to ensure its safety, manufacturing process validation has to be done. It is the essential element in ensuring that a drug product is pure, efficient, save and that its quality …
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 pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper environmental conditions in the manufacturing area. Therefore, environmental conditions of the manufactur…
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 must be resistant to abrasion and impact since the plant’s floors could easily be exposed to heavy traffic from hefty tools and machinery. A type of floor coating that can surely offer durable and hard wearing solutions is the epoxy flooring. This type of floor …
