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 …
Equipment Lubricants Used in Pharmaceuticals
Lubricants are used to minimize the faction between the moving surfaces of the machines. The fraction may cause the heating of the moving parts. It also helps to minimize the load on the machine and rust. Generally, lubricants are prepared with organic and synthetic compound those are not permitted in pharmaceuticals.
ALCOA in Pharmaceuticals : A necessary tool for Quality
Any pharmaceutical product has to undergo a process before it can be used by the public. This process ensures that the product is safe for everyone. And if there are any side-effects of the product, the consumer can be warned about them beforehand. This helps to decide for whom the product would be suitable.
How to Care for pH Meter Electrodes
pH meter electrodes measure the degree of acidity by comparing the aqueous solutions. The electrodes are immersed in with the reference half-cells built inside the electrodes. These half-cells are coated with silver chloride or AgCl.
Gap Analysis for Regulatory Compliance
If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis.
Sanitation of Cleanroom Area in Pharmaceutical Manufacturing
It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. The area should be clean after a defined period as per standard operating procedure.
Activated Carbon Filter and Increase in Efficiency for Water System
The activated carbon filter is used to remove chlorine and organic matter from the water. It also removes the color and odor from the water hence the turbidity of the water is also removed. It plays an important role in water purification systems where chlorine is added for decontamination. ACF is unable to remove the microbes and hardness.
Biofilm Removal and Chemical Sanitization of RO Systems
To control microbial growth, RO systems must be chemically sanitized on a regular basis. Prior to sanitation, it is important to chemically clean the first-pass RO system. This will help to disrupt any biofilm that protects viable bacteria from contact with the sanitant. It also removes foulants that will react with and chemically deplete the sanitizing agent.
Planning and Procedure followed During Regulatory Audits
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.
1 Routine Inspection: Quality System Inspection
2. Pre-approval Inspection for Pre-market Approval (PMA): Country-specific inspections
3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's comp…
1 Routine Inspection: Quality System Inspection
2. Pre-approval Inspection for Pre-market Approval (PMA): Country-specific inspections
3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's comp…
Various Types of Blenders and Their Purpose
A blender is a very important equipment in the pharmaceutical industry, as a medicine is manufactured by mixing a number of drugs and chemicals. This mixing is required to be undertaken in either dry or wet state depending upon the chemical composition and the reactions allowed. There are various types of blenders available in the industry, each one having its own purpose. Some of them are discus…
Duct Designing in HVAC System
Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill.
Lean Six Sigma Concept
Lean Six Sigma (LSS) is a combination of two processes that were initially applied separately to improve business efficiency and effectiveness. In a nutshell, the lean methodology is aimed at reducing or totally eliminating steps that do not add value in a manufacturing process and six sigma is a data-driven methodology aimed at producing a continuous process with low defects.
Difference Between HEPA and ULPA Filters
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…
