One of the most difficult and critical areas in designing a pharmaceutical facility is establishing the clean room. The clean room is not merely a controlled area but rather a specifically engineered environment to reduce the chance of contamination and ensure that all of the environmental conditions like air quality, humidity, temperature and pressure within it are maintained consistently.
The Rotation of Disinfectants Principle - True or False? | Understanding Effectiveness in Pharma Cleaning
This is something many quality professionals debate about, so not everyone feels the same way about how important disinfectant rotation can be. There are some quality professionals who believe that using different disinfectants at different times will make it less likely that microorganisms will become resistant to the disinfectant and therefore continue to provide effective cleaning and sanitiza…
Common Causes of Low Quality Products in Pharmaceuticals | How to Prevent Them
In pharmaceutical manufacturing maintenance of high product quality is a top priority. When products do not meet the required standards for quality, regulatory enforcement actions and product recalls may result in harm to patients as well as negative and long-term impacts on company's reputation.
Factors Affecting the Bioavailability of Drugs | Explained with Examples
The effectiveness of any medicine depends upon its bioavailability. It indicates the ability of drug by which it can enter the blood stream and provide a therapeutic effect. Even the most active chemical must be bioavailable to effectively treat the condition for that it was given.
In-Process Control Methods for API Manufacturing | Ensuring Consistent Quality
Precision, uniformity and adherence to stringent regulations are the requirements of drug manufacturing. Drugs are produced using active pharmaceutical ingredients which will always control the effectiveness and safety of the drug for the consumer.
Common Microbiology Concerns in FDA Inspections | Key Issues and Best Practices
Microbiology plays an important role in FDA inspections, whether it is in sterile manufacturing or non-sterile manufacturing because problems with microbial control systems will affect product quality and patient safety.
How to Improve Pharmaceutical Manufacturing Facilities | 12 Effective Strategies
Drug production takes place in pharmaceutical manufacturing plants, which serve as the heart of drug production. They take raw materials and complex formulations and turn them into safe, effective and high-quality medicines for patients worldwide.
Tips for an Effective Internal Audit System in Pharmaceutical Manufacturing
A pharmaceutical company's Quality Management System (QMS) relies heavily on Internal Audit, which can be a useful tool when it comes to identifying compliance gaps, weaknesses and potential improvements prior to being alerted by a regulator. The internal audit process is designed to enhance the GMP compliance and to promote a culture of continuous improvement.
Building Better Pharmaceutical Manufacturing Facilities | A Guide to GMP Compliant Design
The quality of pharmaceutical products starts long before the actual manufacturing process starts. It starts with the infrastructure of the facility that is actual physical structure where each equipment, machine and worker collaborates to create safe and effective pharmaceutical products.
Ultrasonic Cleaning in Pharmaceuticals | Process, Validation and Benefits
Pharmaceutical cleaning is not only the best practice to keep your manufacturing operation clean. It is also a critical regulatory and quality requirement. All equipment and tools that are used during pharmaceutical product processing must be cleaned to prevent any cross contamination between products, maintain the integrity of the product during manufacturing and be in compliance with Good Manuf…
How FDA Inspections are Conducted in Pharmaceutical Manufacturing Facilities
FDA is responsible to make sure that pharmaceutical products in the market are safe, effective and of high quality. FDA regularly inspects drug manufacturers located in the US and abroad to assess their compliance with cGMP.
Performance Qualification (PQ) in Pharmaceuticals | Process, Protocol & GMP Compliance
In the field of pharmaceutical manufacturing, producing a high-quality product is not related to how well you design and install equipment but it’s also about consistent operation under actual working conditions. This consistency is what both regulatory agencies and patients require.
Operational Qualification (OQ) in Pharmaceuticals | Steps, Testing & GMP Requirements
All processes and equipment within pharmaceutical manufacturing must function correctly at all times, not just sometimes or nearly correctly but with absolute certainty. Such confidence in an equipment or manufacturing process comes from a formalized qualification method that outlines the four qualification phases for new equipment or systems (DQ, IQ, OQ, and PQ).
Installation Qualification (IQ) in Pharmaceuticals | Purpose, Procedure and Documentation
The qualification of equipment in pharmaceutical manufacturing is not simply a compliance requirement. But it is part of the scientific process utilized to ensure that the equipment, utilities or systems will continue to perform as expected. The qualification process consists of several phases.
Design Qualification (DQ) in Pharmaceuticals | Purpose, Process and Documentation
Equipment, systems, and components used throughout the pharmaceutical manufacturing process are essential to ensuring the safety, quality and regulatory compliance of products manufactured. Before installation and qualification of any equipment, it must be demonstrated that it is designed for its designated purpose and is compliant with regulations of GMP.
Quality Risk Management (QRM) in Pharmaceuticals | ICH Q9 Guidelines, Process & Tools
To guarantee that their products are safe, effective, and of the best quality before being distributed to patients, the pharmaceutical industry is highly regulated by government organizations, which means that compliance alone does not provide confidence; instead, a durable and proactive methodology for risk identification, analysis and control must be used to ensure a sufficient level of confide…
User Requirement Specification (URS) in Pharmaceuticals | Purpose, Format and Examples
The User Requirements Specification (URS) is the initial document that establishes the quality and regulatory compliance of all instruments, machines and systems in the pharmaceutical industry, well before the actual use of equipment or implementation of systems.
Site Acceptance Test (SAT) in Pharmaceuticals | Process, Protocol & GMP Compliance
The qualification of equipment in the manufacturing of pharmaceuticals is an organized approach to confirm that the systems perform as expected. When equipment passes the Factory Acceptance Testing (FAT) at the vendor's location, it is tested again when installed at the manufacturing site. This testing is referred as the Site Acceptance Testing (SAT).
Factory Acceptance Test (FAT) in Pharmaceuticals | Process, Protocol & Importance
In the pharmaceutical industry, the equipment and automated systems must be tested for reliability before being installed into a manufacturing facility. One of the most common methods of testing for reliability is through a Factory Acceptance Test (FAT). The FAT is a critical test for validating equipment and automated systems to ensure that the performance, compliance and quality of equipment is…
GMP in Detail | Components of Good Manufacturing Practices
Pharmaceutical Quality Assurance is established through Good Manufacturing Practices (GMP). GMP provides a structured framework to ensure that all pharmaceutical products are manufactured reliably so that each product meets its specifications based on quality standards.
Difference Among Calibration, Validation and Qualification | Explained with Examples
To ensure the quality, consistency, and compliance of pharmaceutical products, controlled and reliable equipment, systems and processes are required. Pharmaceutical manufacturers follow three basic procedures calibration, validation, and qualification to control their operations.
Validation of Excel Calculation Sheets in Pharmaceuticals | Complete Step by Step GMP Guide
The pharmaceutical industry relies on Microsoft Excel very much for several GMP related activities such as calculating assay results, generating calibration curves, storing stability data and performing various other types of GMP related calculations. Although Excel provides flexibility and speed but it can also introduce compliance risks, if not appropriately validated.
Facility Qualification in Pharmaceuticals | Steps, Stages & GMP Requirements
Facility qualification is an essential step at the beginning of implementation of Good Manufacturing Practices in any pharmaceutical manufacturing facility. Facility qualification provides an indirect assurance that the manufacturing site equipment, utilities and systems for manufacturing are correctly installed and operated to produce high quality products consistently.
Current Good Manufacturing Practices (cGMP) | Complete GMP Guide for Pharmaceuticals
All products manufactured in pharmaceutical facilities must meet three criteria; safety, effectiveness and consistency in their quality. To achieve this goal each manufacturer must comply with cGMP regulations which are enforced by regulatory agencies around the world.
Understanding 21 CFR | FDA Compliance Guidelines for Pharmaceutical Manufacturers
Companies in the pharmaceutical industry focused on meeting regulatory and international standard requirements must be aware of the regulations established by US Food and Drug Administration and their corresponding items within 21 CFR Title 21 of the Code of Federal Regulations, which covers the manufacturing of drugs and other products regulated by the USFDA.
Quality Management System (QMS) in Pharmaceuticals | Complete Guide to GMP Compliance
Product quality in pharmaceutical industry is not optional but it is a primary regulatory requirement for every company those manufactures pharmaceutical products. Each batch of medicinal products must be produced according to the quality standards established in their approved specifications. Achieving this level of reliability and quality requires a strong quality management system.
Schedule M Compliance | Complete Guide for Pharmaceutical Manufacturers
Schedule M is a part of Drug and Cosmetic Rules, 1945. It provides good manufacturing practices (GMP) requirements for pharmaceutical industry that must be followed by pharmaceutical manufacturing units in India. Schedule M has guidance on company premises, quality control system, quality control laboratories, GMP in production, cleaning of equipment, housekeeping, cross-contamination and other r…
Validation of Shelf Life for 70% v/v Isopropyl Alcohol | IPA Efficacy Validity Determination
Isopropyl alcohol 70% is one of the most commonly used disinfectants and the pharmaceutical industry. It is used for surface disinfection, equipment sanitization, hand decontamination in cleanrooms and aseptic processing areas.
USFDA Guidelines for Pharmaceuticals | Complete FDA Compliance Guide
USFDA has great importance in ensuring the safety, efficacy and quality of pharmaceutical products sold in the United States market. The guidelines published by the FDA form a strong foundation of drug development, manufacturing, quality control and distribution of pharmaceutical products worldwide.
Purified Water Systems in Pharmaceuticals | Types, Design and Uses
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…
