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…
Color Codes for the Gas Cylinders in Pharmaceuticals | ISO and BIS Color Codes
Gas cylinders are widely used for various purposes in pharmaceutical industry from sterile operations and laboratory testing to manufacturing and packaging. The gases in the cylinders are stored at high pressure, so these must be handled carefully.
Understanding GxP in Pharmaceuticals | Types, Purpose and Importance of GxP
One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations …
Different Mesh Sizes and Mesh to Micron Conversion
Sieves and screens are widely used in pharmaceutical manufacturing as well as in the quality control to determine the particle size of the raw materials. Mesh is the most common measurement unit used for the sieves and screens. Generally, 40 to 400 mesh sieves are used in pharmaceutical manufacturing during shifting and milling of raw material.
Purified Water System Validation | Steps, Phases and Compliance Guide
In pharmaceutical industry, water is the most critical utility used in manufacturing process and washing of equipment. It is used as the raw material, cleaning agent and a medium in formulation. Water should meet its quality standard because it comes in direct contact with the drug products.
Sustained Release and Prolonged Release Tablets and their Difference
In modern drug delivery the focus is not just on developing new molecules but on achieving maximum therapeutic benefits from the dose with minimum side effects. Controlled drug delivery systems such as Sustained Release (SR) and Prolonged Release (PR) tablets played a major role in this therapeutic evolution.
Lessons from Major Regulatory Non-Compliance Cases
In the pharmaceutical industry, regulatory compliance is not optional but it is the foundation of trust, product safety and patient health. Global regulatory standards are strict but still many pharmaceutical companies have faced serious regulatory actions for noncompliance. These issues not only cause financial losses but also damage the reputation of manufacturing company.
Basics of HVAC System | HVAC Components, Working and Airflow Diagram
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.
21 CFR Part 11 Requirements for Laboratories | Tips for Compliance
In pharmaceutical laboratories electronic data systems have replaced paper documentation. Instruments like HPLC, GC, Spectrophotometer and stability chambers now generate electronic data that is processed digitally. This electronic system improved efficiency and traceability of the instruments and their data.
Preparation of Buffer Solutions | Phosphate, Acetate and other Buffers
Buffer solutions play an important role in ensuring product stability and providing environment for chemical and biochemical reactions. Buffers are used in analytical methods, formulation development and stability studies of products. It is essential to understand how to prepare buffer solutions correctly to achieve reliable results in laboratory and manufacturing of pharmaceutical products. This…
ALCOA, ALCOA+ and ALCOA++ Principles | Ensuring Data Integrity in Pharmaceuticals
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. It is further extended to ALCOA++ by adding Integrity, Robustness, Transparency, Accountability and Reliability.
Introduction, Classification and Definitions of Dosage Forms
Introduction to Pharmaceutical Dosage Form Drugs are rarely delivered as pure chemical entities but are approximately usually provided as prepared formulations i.e. dosage form. After converting them into an appropriate dose formulation, they are delivered in several dosage forms.
Climatic Zones for Stability Studies | Climatic Zone Classification & Conditions
Stability study is an important part of pharmaceutical product quality. For safety, efficacy and quality of pharmaceutical products, environmental conditions are the most significant factor that influence drug stability because product is stored, transported and used in these conditions. Environmental conditions are different and different reasons of the world. The world health organization (WHO)…
Auditing Suppliers: What Pharmaceutical Auditors Look for and How to Prepare
In pharmaceutical industry materials are supplied from different suppliers. Supplier audits are a critical part to ensure the quality and safety of raw material, components, packaging materials and other outsourced services. Regulatory agencies like USFDA, EMA, MHRA, and WHO expect manufacturers to maintain a perfect supplier qualification program that includes internal audits, periodic reaudits …
