An Approach To The Validation Of Medical Devices And Critical Issues In Each Step Of The Process

Validation of the medical device is generally developed according to the steps shown in Figure 2. 1. A critical issue in the development stage in step 1 is that the concept of the product developed should satisfy functional and safety aspects to achieve the expected treatment effectively. When the concept is developed, it must be reviewed based upon risk assessment. One of important issues in step 1 is to establish whether the device will be sterile or not. 2. A critical issue in the design of...

Finished Product Attributes

There are unique dried material quality attributes associated with lyophilized materials. The term dried material is used loosely here and meant to encompass both lyophilized drug substances and intermediates, as well as drug products intended for administration. Quality attributes are nearly identical for each type of material, whether drug substances or finished drug products. Stringent microbiological quality is also a requirement for sterile drug products, whereas an acceptable level of...

Supplier Selection

Manufacturing process control and automation systems can be divided into two main categories 3 . Stand-alone systems. Multiloop controller(s) or programmable logic controllers (PLC) typically used to control part of a process, and larger supervisory control and data acquisition (SCADA) systems distributed control systems (DCS) used to control the process or service as a whole (e.g., bulk primary production plant, building management systems). These self-contained systems are a component of an...

Outsourcing And Contract Manufacture

With respect to the pharmaceutical industry, outsourcing and contract manufacture probably got its start with APIs, final and key intermediates, and other steps in the synthetic process because of the complexity of API manufacture. The advantages and disadvantages of outsourcing and contract manufacture are presented as follows Advantages Less expensive to purchase Access to specialized and new technologies not currently available inplant Availability from known suppliers with more chemical...

Introduction A Outsourcing

Within the last 10 years the pharmaceutical industry has faced a tremendous amount of pressure on dual fronts. The inventory of the new drug molecule is running low, and the health care marketplace is exerting pressure on the industry to contain the costs of medicine. The industry is struggling to replenish the dwindling drug molecule pipeline. The impact of these pressures on the pharmaceutical industry is evident in the mergers and acquisitions that have taken place in the last 10 years....

Project Management

Good project management is the first step toward organizing the successful qualification of a technical system. A well-structured and -planned approach to qualification is the first step toward success. The tools and methods of project management are mainly used for large and complex projects. It is equally important to apply these management skills to smaller projects, however. A good project start is the best way to win the battle. To start with, the project organization must be defined. The...

Types of Metered Dose Aerosols

Nearly all MDI products are intended for delivery through the oral cavity 3 . There are a few products that are intended for administration via the nasal cavity, however. There is also a metered-dose aerosol for administration sublin- gually. The site of administration will determine the type of actuator or adapter used in combination with the aerosol canister. Metered-dose inhalers are unique in that in addition to drug formulation, the entire packaging is critical for the correct...