The World Health Organization defines ‘Good manufacturing practice (GMP)’ as a system for ensuring that products are consistently produced and controlled according to quality standards. GMP minimizes the risks involved in pharmaceutical production that cannot be eliminated through testing of the final product, including:

• Unexpected contamination of products resulting in damage to health or even death
•  Incorrect labels on containers that could result in patients receiving the wrong medicine
•  Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects

GMP covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. Systems must be in place to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process—every time a product is made. CTG’s GMP services include:

• Regulatory compliance consulting in areas such as risk management, in a wide range of manufacturing environments (e.g., process, manufacturing units, facilities, and engineering)
• Guidance in the generation of written procedures to support GMP
• Process improvement consulting for manufacturing, including the identification of improvements to manufacturing processes or associated compliance processes to improve efficiency and maintain compliance
• Complete manufacturing process validation for newly-constructed or -modified manufacturing facilities
• Compliance training focused on the manufacturing environment