Subject: QA/QC

Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems

With a focus on the FDA Draft Guidance In recent years, states the Agency, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. While a few of these situations may actually involve intentional fraud, others may occur where simply inadequate controls have been put into place to prevent data manipulation. Whether intentional… Continue reading Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems

Out-of-Specification (OOS) Result Investigation

How to Perform a Compliant, Effective, and In-depth Out of Specification (OOS) Investigation Some FDA (form 483s) and other regulatory bodies inspectional findings, FDA warning letters, product recalls and plant shutdown (voluntary or involuntary) sometimes relate to incomplete, ineffective, and non-compliant OOS investigations that impact a manufactured product. Per the regulations, all Failures, Deviations, or… Continue reading Out-of-Specification (OOS) Result Investigation

Analytical Methods Validation for FDA Compliance

One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process… Continue reading Analytical Methods Validation for FDA Compliance

Annual Product Reviews/Product Quality Reviews

Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as… Continue reading Annual Product Reviews/Product Quality Reviews

Conducting a Robust Root Cause Investigation for CAPA

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of a sub-standard product, or product recall. Furthermore, costly… Continue reading Conducting a Robust Root Cause Investigation for CAPA

GMP in a Nutshell: An Introduction to cGMP

“Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current… Continue reading GMP in a Nutshell: An Introduction to cGMP

Introduction to Pharmaceutical Quality Management Systems

This 90-minute ON DEMAND accredited online training course describes the requirements of an effective, comprehensively designed and correctly implemented Pharmaceutical Quality Systems (PQS) that incorporates Good Manufacturing Practice, Controls, Continuous improvements, and Quality Risk Management. All parts of the PQS should be adequately resourced with competent personnel, suitable and sufficient premises, equipment, facilities, processes, and… Continue reading Introduction to Pharmaceutical Quality Management Systems

Computer System Validation: Rules and Tools

Since the 1980’s the FDA and International regulatory agencies have been very concerned about the increased use of computer systems for reporting, clinical trials analysis, and communication. Early validation guidance’s focused on processing and reporting. However, today the industry is dependent on the use of computer systems. Developments in areas such as Artificial Intelligence, computer-controlled… Continue reading Computer System Validation: Rules and Tools

GLP and Quality Assurance: Developing a GLP Compliant QA Program

Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to perform the role of Quality Assurance for laboratories… Continue reading GLP and Quality Assurance: Developing a GLP Compliant QA Program

Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure… Continue reading Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program