Parameter Generation And Control Care Guide

Listing Results Parameter Generation And Control Care Guide

Frequently Asked Questions

• What is GPP ?

  Part of batch release Parameters that affect classified as critical •If parameter affects process performance then key Defined general process parameter (GPP) as anything that is not critical and is well controlled, ie, all other parameters •Defined key performance attribute as in-process output that measures process performance, eg yield

• What are the three classifications of parameters?

  •Essentially, parameters were lumped into three classifications Critical Operation outside a narrow range affects a CQA Key Operation outside a narrow range affects performance Non-key Parameters that have wide operating ranges Doesn’t differentiate as to what the parameter affects

• Do the agencies support the term “key process parameters” ?

  Answer… The Agencies do not support the use of the term Key Process Parameters (KPP) since it is not an ICH terminology. Furthermore, experience reveals that different applicants use the term “key” differently, leading to more difficult internal communication.

• What is the difference between critical and non-key parameters?

  Critical Operation outside a narrow range affects a CQA Key Operation outside a narrow range affects performance Non-key Parameters that have wide operating ranges Doesn’t differentiate as to what the parameter affects 4

• What is parameter generation and control?

  Parameter Generation And Control (Parameter) has specialized in the manufacturing of equipment to provide precise relative humidity and temperature control in rooms, reach-in chambers, and existing structures since 1977. Parameter utilizes the “two-temperature” method as our standard control process.

• What is process control and process variability?

  Process control aims to ensure that process variability is controlled within specifically defined boundaries, and derived from current product and process understanding, to guarantee quality of the product. At a minimum, the process control strategy should address monitoring and control of critical process parameters.

• Why choose parameter for temperature control?

  Parameter has long been on the cutting edge of innovation, offering precise temperature & humidity control with greater precision that no other manufacturer has replicated. Our equipment will meet or exceed your industry regulatory requirements. We adhere to all standards and regulations required by the FDA, TAPPI, ICH and ISO.

• What is a parameter system?

  In a Parameter System, the volume of the air flow required for maintaining room or chamber uniformity prevents the process air from reaching actual saturation in the saturator. The air circulating through the saturator does not cool down to the same temperature as the water temperature.