Title: Why are Production and Process Controls Necessary?
Course: PW-Course-Import-Test > Section: Module 4: Production and Process Controls

Module 4

The purpose of Production and Process controls is to ensure that the device conforms to specifications, to ensure that regulatory requirements are met, and to keep the end user safe.

Watch

Watch this video to see a brief explanation of a general closed loop process control. In the video, notice the presence of a “measurement” step. In a medical device manufacturing environment, the measurement step is closely associated with a Production and Process control mechanism. Introduction To Process Control

Watch Subpart G Production and Process Controls to see a description of 21 CFR 820.70 and and the other subparts listed below:

Read

Read PP&C Overview Subpart G, a summary of the key points of Subpart G.

Subpart G is has process adjacencies/interdependencies with the following subparts. Several of the following subparts and short, concise descriptions of the regulatory requirement. For Subpart M, N and O, the learning exercise will simply consist of reading these subparts as part of the overall review of the regulation.

Read the following interdependent subparts for Subpart G.

PP&C Overview Subpart H Acceptance Activities which covers the three types of primary acceptance activities: Receiving, In-Process and Finished Device acceptance.

PP&C Overview Subpart I Nonconforming Product which covers the requirements related to nonconformances.

Subpart J and Subpart M are covered in more detail in subsequent learning modules.

Follow the link to the FDA website to read the regulation directly for the following subparts:

Subpart J - Corrective and Preventive Action (CAPA). Although covered as part of the sequence of reviewing the regulations in order, this topic is covered in detail in Module 5.

Subpart K - Labeling and Packaging Control covers device labeling and device packaging.

Subpart L - Handling (820.140), Storage (820.150), Distribution (820.160) and Installation (820.170) covers the four areas mentioned - Handling, Storage, Distribution and Installation.

Subpart M - Records covers the general requirements for Record control. Although covered as part of the sequence of reviewing the regulations in order, this topic is covered in detail in Module 6.

These following subparts also have interdependencies. Because they are very small/concise sections of the regulations we will just read them as part of the overall regulation review:

Subpart N - Servicing

Subpart 0 - Statistical Controls.