Subject: QA/QC

Combination Product Risk Management Principles: An Engineering and QA Perspective | Part 2

Managing the complex lifecycle of combination products requires the efficient utilization of resources of a pharma/device company regardless if the company is vertically integrated, utilizes both in-house and contract manufacturing, or is a truly virtual company. This second of two 90-minute accredited training courses will define and apply recognized risk management principles in developing effective… Continue reading Combination Product Risk Management Principles: An Engineering and QA Perspective | Part 2

Basic FDA GLP Training (Good Laboratory Practice Training)

No drug makes it into human usage without having first been demonstrated safe in animal models. Good Laboratory Practices (GLPs), which grew out of a lack of quality and scientific integrity in toxicology studies conducted in the 1970s, established FDA’s requirements for the conduct of such nonclinical studies. Bioanalytical analyses for GCP-regulated studies are also… Continue reading Basic FDA GLP Training (Good Laboratory Practice Training)

Basic Principles of GCP (Good Clinical Practice)

Good Clinical Practice (GCP) standards, required by the FDA and international regulatory bodies, provide assurance that the data and reported results are credible and accurate, and the rights, integrity, and confidentiality of trial subjects are respected and protected. During this 90-minute, intensive training, participants will obtain a comprehensive overview of the purpose, scope, and legal… Continue reading Basic Principles of GCP (Good Clinical Practice)

Basics of Electron Beam Sterilization Process Requirements

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Electron Beam Sterilization Process Requirements

Basics of Gamma Radiation Sterilization Process Requirements

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Gamma Radiation Sterilization Process Requirements

Basics of Ethylene Oxide Sterilization Process Requirements

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Ethylene Oxide Sterilization Process Requirements

FDA Inspection Essentials: Key Dos and Don’ts

The purpose of the Regulatory Inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a… Continue reading FDA Inspection Essentials: Key Dos and Don’ts

Laboratory Controls Overview & Establishment of Specifications

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. Consistent with current Good Manufacturing… Continue reading Laboratory Controls Overview & Establishment of Specifications

Analytical Methods Validation – 21CFR211.165(e)

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 – 21CFR211.165(e)

Stability Testing – 2 CFR 211.166 (a & b)

In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. In the absence of the detailed FDA guidelines, industry was left to interpret the somewhat ambiguous GMPs. The fact that stability issues continue to be a major cause for regulatory action… Continue reading Stability Testing – 2 CFR 211.166 (a & b)