Industry: Analytical Chemistry

Supervising a Human Error Free Environment 

Supervision plays a crucial role in Human Error Reduction and Control. In this fully accredited training, critical factors like preparation, planning, scheduling, communication, among many others, will be discussed. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of… Continue reading Supervising a Human Error Free Environment 

In-depth Look into Softgel Formulation, Manufacturing and Troubleshooting

Softgels are widely popular dose forms for liquid that represent the most important oral form for less than 5 milliliters of liquid. Additionally, softgels are vital as a lipid delivery system, enhancing both solubility and permeation of Active Pharmaceutical Ingredients (APIs) by targeting the lipid absorption route. Softgels may appear to be a simple, two-part… Continue reading In-depth Look into Softgel Formulation, Manufacturing and Troubleshooting

GMP Change Control Process

Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many… Continue reading GMP Change Control Process

Precision Tools for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be managed,… Continue reading Precision Tools for Human Error Reduction

Introduction to Softgel Manufacturing and Controls

Softgel dosage forms represent a modern take on the traditional tablet product, the most common type of pharmaceutical products produced. In the patient’s hand, a softgel can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind… Continue reading Introduction to Softgel Manufacturing and Controls

Introduction to Tablet Manufacturing by the Direct Compression Process

Solid oral dosage forms such as tablets and capsules represent the most common type of pharmaceutical products produced. In the patient’s hand, a tablet can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind the ingredients… Continue reading Introduction to Tablet Manufacturing by the Direct Compression Process

IQ, OQ and PQ for the Laboratory

The FDA’s 21 CFR Part 211.160 establishes the legal requirement for calibrating laboratory equipment. Now more commonly referred to as Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ), the qualification of equipment in a GMP Laboratory in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process and ongoing commercial batch release. Data… Continue reading IQ, OQ and PQ for the Laboratory

Good Documentation Practices for Laboratory Records

In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Good documentation practices are expected… Continue reading Good Documentation Practices for Laboratory Records

Handling OOS Test Results and Completing Robust Investigations

It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not… Continue reading Handling OOS Test Results and Completing Robust Investigations

Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the different regulations guiding the manufacturing and testing of products. A well-established procedure and test method improves the numbers of manufacturing, testing and personnel deviations which indirectly affects the quality and life cycle process of a manufactured… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements