PTS - GMP Compliant Engineering Programs

Compliant Production Programming

The manufacture of safe and effective products is the heart of a pharmaceutical, device, API or related facility. Compliant production leading to the relief or diagnosis of medical conditions is the reason the the site exists, the folks are employed and the industry is regulated. Just as in all areas of regulatory compliance, the activities have to be defined by procedures, executed as per the those procedures and adequate records maintained to provide evidence of compliance with the defining procedures.

Years of experience in operating facilities provides the basis for comprehensive production procedures and evaluations that can withstand regulatory scrutiny. PTS can help develop programs in areas such as the following:

Documentation (SOPs, Batch Record Review)
Cleaning Procedures
Environmental Monitoring (Differential Pressures, Temperature, Humidity)
Line Clearance
Process, Product, People flow patterns
Cross Contamination Controls
etc.

PTS has helped clients by assessing and addressing deficiencies in the manufacturing areas that can ensure appropriate procedures, practices and paperwork are maintained. Compliant, yet pragmatic, is the continuing theme in developing such procedures - a theme PTS always keeps in the forefront.

PTS is ready to help your organization establish a sustainable program for controlling your Production operation.