gmpbasics

Process Description is a written description of a specific manufacturing process with explcit
infromation regarding each step and all variables associated with the process and product.
Description of equipment and process steps, along with all specific parameters, are included
to provide a detailed description of the performance required in order to produce the product in
question.

The Process description should cover issues such as:

- Raw material
- Equipment preparation, operation, and performance
- Product specifications for final product and each process step
- System descriptions
- Unit operation descriptions

"State of Control"- Although GMP compliance relies haevily on protocols and SOPs, the intent
is to get beyond checklists to a point at which you can describe what is happening in your
facility, and also what has happened in your facility, for each step of each process. Having
personnel and procedures in place, along with detailed documentation and sampling regimes
constitute the desired state of control as it affects product quality.

Baseline Documentation is the basic infromation which is used to describe the basic
performance of the basic manufatcuring process and how it will be accomplished.

Baseline documentation would typically consist of:

- Process description
- Process Flow Diagram
- Equipment List
- Process and Instrumentation Diagrams
- Equipment General Arrangment
- Facility General Arrangemnt and associated flow diagrams