Subject: QA/QC

CAPA: A Critical Quality System Requirement

The Role of Corrective Action and Preventative Action in Your Quality System There has been several form 483’s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to corrective action and preventative action programs (CAPA). Addressing an FDA form… Continue reading CAPA: A Critical Quality System Requirement

Quality Management and Compliance in the Pharmaceutical and Related Industries

Under the global regulator-based inspection approach, the Quality system is one that is routinely audited. Quality issues are a huge factor in inspection observations leading to recalls for drugs, biologics, and medical devices. This indicates that not all companies are meeting current GMP expectations. Clearly a better understanding is needed to overcome this trend and… Continue reading Quality Management and Compliance in the Pharmaceutical and Related Industries

Sterile Products: Formulation, Manufacture and Quality Assurance

Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to… Continue reading Sterile Products: Formulation, Manufacture and Quality Assurance

Drug Product Stability and Shelf-Life

“An Intensive Review of Technical and Regulatory Aspects No drug product enters the marketplace without adequate stability data first. While ICH has harmonized and standardized the approach to performing stability, a number of challenges are still routinely faced while conducting stability testing. Since inadequate stability can lead to product introduction delays, all drug companies need… Continue reading Drug Product Stability and Shelf-Life

Regulatory Compliance for the Personal Care Products Industry

“Since in many countries, Personal Care products do not require Health Authority review and approval prior to marketing, there is often confusion about what product claims can be made, what labeling is required, and what ingredients cannot be used. Without knowledge of the regulations in each country, non-compliant product is often detected by Health Authorities… Continue reading Regulatory Compliance for the Personal Care Products Industry

Writing and Enforcing SOPs: Best Practices for Regulated Industries

“Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose. This… Continue reading Writing and Enforcing SOPs: Best Practices for Regulated Industries

Qualification and Management of CMOs (Contract Manufacturing Organizations)

Every pharmaceutical company hopes to obtain their desired expectations when it comes to important relationships with their Outsourcing Partners. This intensive course examines the root causes of critical issues that can arise within these relationships which are much broader and deeper than the technical capability to perform a process. This intensive 12-hour, accredited course, examines… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)

GMP Laboratory Control Professionals Certification

In their own Guide to inspecting Quality Control Laboratories, FDA states: 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. Accurate, reliable, and meaningful laboratory data is critical… Continue reading GMP Laboratory Control Professionals Certification

Sterilization Professionals Certification

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification

FDA Inspection Readiness Certification

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 FDA Inspection Readiness Certification