Industry: Analytical Chemistry

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

Pharmacopoeia Compliance: An Overview [FREE WEBINAR]

How to Meet Legal, Regulatory, and Compendial Requirements Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry.… Continue reading Pharmacopoeia Compliance: An Overview [FREE WEBINAR]

Introduction to Softgel Manufacturing and Controls

Softgel dosage forms represent a modern take on the traditional tablet product, the most common type of pharmaceutical product 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

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, Development, Drafting, Processing and Approval of An Effective and Compliant SOP or STM 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… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

BioPharmaceutical Analytics: Regulations and Validations

This 6 hour accredited ON DEMAND training will teach basic analytical regulations as they apply to method validations. This course, divided into four segments, will go through multiple bioanalytical methods and how to examine them for validation readiness and how to perform a validation. The methods in this course will include UV-VIS, SE-HPLC, HIC HPLC,… Continue reading BioPharmaceutical Analytics: Regulations and Validations

Laboratory Controls: Anticipate the Systems Based FDA Inspection

In this 90-minute accredited training, we will discuss laboratory controls. It will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to prepare your laboratory for FDA. Many QA and QC personnel… Continue reading Laboratory Controls: Anticipate the Systems Based FDA Inspection

Data Integrity Practices for the Laboratory and Beyond

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory… Continue reading Data Integrity Practices for the Laboratory and Beyond