Subject: GMP

Understanding the Process Validation Life Cycle

This training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological/pharmaceutical industry. This course is further intended to discuss the life cycle of the Process Validation system. You will learn when a process should be validated, the basic components of a Process… Continue reading Understanding the Process Validation Life Cycle

Effective Handling of cGMP Raw Materials

cGMP raw materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is an integral and essential process that ensures drug product quality, purity and potency. Drug product manufacturers must have… Continue reading Effective Handling of cGMP Raw Materials

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

Stability Operations for Drugs, Biologics and Medical Devices

This accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample management. Preparing for inspections and… Continue reading Stability Operations for Drugs, Biologics and Medical Devices

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

Stability Testing for Protein Drug Products & Substances

No drug substance or drug product is acceptable without a satisfactory stability profile. Yet, protein drug substances and drug products offer unique challenges when it comes to stability. From storage to handling, to testing, proteins often require thinking creatively to achieve an acceptable stability program. This intensive course provides comprehensive and up-to-date knowledge of developing… Continue reading Stability Testing for Protein Drug Products & Substances

Effective Approach to Human Error Reduction

In GMP regulated industries, it is not enough to address human error deviations as an inconvenience; it is a regulatory requirement. The quality control unit is responsible for ensuring that errors are fully investigated and prevented as per the Code of Federal Regulations (21 CFR 211.22). However, human error is not a root cause but… Continue reading Effective Approach to Human Error Reduction

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

OTC Stability Program for FDA Compliance

In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. With the ICH guidance documents covering New Chemical Entities (NCEs) and their associated drug products, there was no guidance provided for OTC drugs covered by an ANDA or an OTC monograph.… Continue reading OTC Stability Program for FDA Compliance

Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems

“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 or not, FDA views these situations as unacceptable.… Continue reading Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems