Subject: QA/QC

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

Designing and Testing Performance of Effervescent Products

How to Ensure Your Product Gets a Fizz Effervescent tablets have been used as products in the pharmaceutical and dietary industries for over two centuries. Rising demand for maintaining a healthier lifestyle is primarily responsible for driving the global effervescent products market. This is mainly due to the fact that effervescent products form a key… Continue reading Designing and Testing Performance of Effervescent Products

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

How to Manage and Prepare for a Pre-Approval Inspections (PAI)

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 How to Manage and Prepare for a Pre-Approval Inspections (PAI)

Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible.… Continue reading Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

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

Basics of Microbiology

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 Microbiology

Requirements for Aseptic Techniques and 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 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Requirements for Aseptic Techniques and Practices

Computer System Validation and Part 11 Compliance

Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. This 90-minute accredited ON DEMAND training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining… Continue reading Computer System Validation and Part 11 Compliance

Writing and Enforcing Effective SOPs Basics

This 90-minute accredited training will address how to write effective Standard Operating Procedures in support of your company’s activities. You will learn how to organize and deliver information for the intended audience and purpose. You will learn how to write clear and readable documents, and how to revise and refine your own and others writing.… Continue reading Writing and Enforcing Effective SOPs Basics