The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases. This article discusses the final two phases.
The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification of a new facility can be broken into six phases. This article will discuss the sampling preparation phase and sampling execution phase.
This article is the first in a three-part series describing an engineering approach to establishing an environmental sampling plan for a new pharmaceutical or biopharmaceutical manufacturing facility. The series assume the facility has just been built and no manufacturing of batches have been run.
Companies in the pharma industry are increasingly hiring consultants to meet the objectives of small to large capital projects. It's important that companies motivate their consultants to their maximum abilities
Clients must set appropriate goals before hiring consultants to ensure the project is completed as efficiently and effectively as possible despite the potential obstacles that can obstruct the path of focus. This article will focus on five essential steps to set appropriate goals for a successful client/consultant relationship
Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.
The biopharmaceutical industry is continuously undergoing organizational changes intended to better support the healthcare industries while maintaining quality and reducing cost. This article will illustrate how manufacturers can add value to their operations by using a quality validation risk management approach for the development of sampling plans. Establishing a quality validation risk management approach for all pharmaceutical processes would increase the probability of successful outcomes for both the companies producing the products — by helping to meet regulatory requirements — while better contributing to the quality of healthcare for patients.