Subject: QA/QC

Implementing a Change Control Quality System Successfully

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Implementing a Change Control Quality System Successfully

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

Basics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices

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 Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices

Requirements of Aseptic Processing and Filtration Sterilization

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 Requirements of Aseptic Processing and Filtration Sterilization

Basics of Sterilization by Heat

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 Sterilization by Heat

Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization Processes

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 Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization Processes

Cleanroom, Cleaning, Sanitization and Disinfection Practices

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 Cleanroom, Cleaning, Sanitization and Disinfection Practices

Combination Product Risk Management Principles: Part 1

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 bth in-house and contract manufacturing, or is a truly virtual company. Part 1 of this will define and apply recognized risk management principles in the identification of required GMP’s and… Continue reading Combination Product Risk Management Principles: Part 1