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Good Manufacturing Practice (GMP) Inspections for Biopharmaceutical Utilities

Good Manufacturing Practice (GMP) inspections for biopharmaceutical utilities are typically performed to ensure that the systems and equipment used to support biopharmaceutical manufacturing are designed, installed, operated, and maintained in a manner that ensures product quality and patient safety.

The most common findings in utilities during GMP inspections for biopharmaceuticals can vary, depending on the specific utility system and the stage of the manufacturing process. However, some common findings that inspectors may look for and that manufacturers should pay attention to include:

Read also: GMP Audit Checklist for Pharmaceutical Industry

Inadequate design and qualification of utilities systems: This can include issues such as inadequate design of systems, lack of appropriate documentation, incomplete qualification or validation, or failure to update documentation when changes are made to the system.

Inadequate monitoring and control of utilities: This can include issues such as inadequate monitoring of temperature, pressure, or flow rate, or failure to implement appropriate alarms or other controls to ensure system performance and stability.

Read also: GMP Guidelines for Pharmaceutical Industry

Inadequate maintenance and cleaning of utilities: This can include issues such as lack of routine maintenance and cleaning, lack of proper maintenance records, or inadequate training for personnel responsible for maintaining and cleaning the systems.

Cross-contamination between utility systems: This can include issues such as inadequate separation between different utility systems, or failure to properly clean and sanitize equipment used in different systems.

Read also: Basic GMP Regulations for Medicinal Products

Failure to address deviations and implement corrective actions: This can include issues such as failure to investigate and document deviations from established procedures, or failure to implement appropriate corrective and preventive actions to prevent recurrence.

It is important for manufacturers to implement robust quality systems and to conduct routine self-assessments to identify and address potential issues in utilities systems. This can help ensure compliance with GMP requirements and prevent common findings during GMP inspections.

Read also: GMP Facility Design and 10 Golden Rules

Resource Person: Ahmed Hasham, Ph. D 

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