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Environmental Monitoring

Environmental Monitoring (EM) is a basic requirement throughout numerous industries; food, cosmetics, drugs and medical devices.  It is intended to measure the cleanliness of an area, therefore verifying the biological safety of products being manufactured.  The depth of your EM program will be determined by the industry you’re in, whether or not you claim your…

CDC

Solutions for Maintaining Compliance with the New CDC Vaccine Requirements

Vaccines are critical tools in maintaining the health of our communities. The logistics of delivering vaccines and verifying that they consistently maintain their recommended temperature has always been a difficult task. At times, vaccines were found being stored outside of the manufacturer’s recommended range. Prolonged temperature excursions can result in the vaccines becoming ineffective. In…

Detour

Deviation

A deviation is described as a departure from an approved procedure or specification.  It represents a failure to meet requirements in the manufacture of product, in-process specifications or production requirements.  There is a difference between a planned or unplanned deviation.  Planned deviations have been approved before execution, whereas unplanned deviations (also called incidents) are technically…

Quality Control

GMP Failure Investigations

Investigations (also known as GMP Failure Investigations) are a requirement of 21 CFR 820.  It is expected that medical device manufacturers immediately conduct an investigation on all non-conforming or out-of-specification (OOS) products.  There are three phases to an effective investigation process: Phase 1: As soon as a non-conformance happens, the individual performing the task should…

Root Cause Analysis

Root Cause Analysis

Within various aspects of a quality management system, there is a directive to evaluate the root cause of an issue – this could be risk management, investigations, non-conforming material, corrective actions, etc.  There is a specific process to this concept, along with methods to achieve the answers. A root cause is a factor, or combination…

Hammer

Preventive Action

The next logical discussion is the second half of the Corrective and Preventive Action (CAPA) subject.  According to ISO 9001 section 8.5.3, Preventive Actions identify and eliminate the causes of potential nonconformities in order to prevent occurrence.  These are proactive measures, instead of the reactive steps taken for a Corrective Action. The main goal for…

Crab Logger

HACCP Verification Procedures

The Virginia Cooperative Extension has released a publication discussing the validation of blue crab retort processes. The development and implementation of a Hazard Analysis Critical Control Point (HACCP) plan is a required step for these retort processes. In the publication, we learn about: What a retort cook process validation is Why this process matters How…