30
Jan
SOP Standard operating procedure concept. A yellow folder lies on an office shelf.

How to Effectively Update SOPs for Compliance: Ensuring Alignment Across Procedures

When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions.  While this might seem like the right thing to do for a quick fix, it is crucial to […]

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27
Jan
Businesswoman Looking At Contract Form Through Magnifying Glass

Forgotten Investigation Elements: Historical Analysis

Investigations have historically been among the most commonly cited observations in FDA 483s so a robust investigation strategy is an important element of any firm’s quality program.  A strong investigation is supported by a thorough and complete evaluation of the major elements: root cause analysis, impact assessment and scope, historical analysis, establishment of CAPAs, and a […]

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16
Jan
Technician Inserts Surgical Instruments in Autoclave for Sterilization.

Cleaning Validation Documentation and Monitoring

Some common FDA 483 citations pertaining to cleaning validation are regarding consistency in monitoring of cleaning and the complete documentation of cleaning.  It is critical to implement a robust monitoring process that is supported by detailed documentation.  Ensuring that the SOPs for all aspects of cleaning are clear, detailed, and contain illustrations (where appropriate) to ensure […]

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18
Dec
Equipment Sampling for Cleaning Validation - Lachman Blog

Equipment Sampling for Cleaning Validation

An aspect of contamination control is the assurance that residual material is not carried over into successive batches by incomplete cleaning of equipment. Cleaning procedures (both the cleaning process and the analytical method to verify cleaning effectiveness) to provide this assurance should be validated. Sampling of equipment for the purpose of cleaning validation or cleaning […]

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