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

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

Laboratory Controls: Anticipate the Systems Based FDA Inspection

Many QA and QC personnel in the pharmaceutical industry are not familiar with the FDA systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the most scrutinized areas during these inspections is the laboratory. Because of this, it is important for lab… 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

CMC Writing and Submission Strategies

The CTD is the basis of drug, biologic, and drug-device combination registration applications. A proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. With the prerequisite complete, this accredited training, will provide in-depth instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical… Continue reading CMC Writing and Submission Strategies

Sterilization Professionals Certification Program

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification Program

David E. Wiggins

David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation, and method transfer. Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for method optimization, method validation,… Continue reading David E. Wiggins