Statistical Techniques

Statistical Techniques

There is a requirement in both the 21 CFR 820 and ISO 9001 to utilize statistical techniques.  According to the FDA, “Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.  Sampling plans, when used, shall be…

complaint box (web)

Complaint Files

A requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files.  According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is…

Quality System Record

Quality System Record

While similar in content to a Quality Manual, the Quality System Record is a requirement for the FDA’s 21 CFR 820.  This document must “include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s)…”  Specifically, the FDA is…

Lyophilization Logger Bottles Web

How Can I Validate My Lyophilization Process?

The lyophilization process is essentially freeze-drying, where the environment is at a very cold temperature and the product is within a “vacuum”. During the process, there is a concern with making sure that the shelf is heating up the product to proper temperatures. Typically, this is a stainless steel shelf of a certain size that can be heated from underneath. This heat is applied to the product while under a vacuum and when…

Label Example

Device Labeling

Manufacturers are required to have labels for product and product labeling.  According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…