What is GMP?
The manufacturing practices followed by pharmaceutical firms to ensure that the products produced meet specific requirements for safety, identity, strength, purity and quality are the basis of GMP.
They are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing of final product.
Main Risks of Disregarding GMP:
- Unexpected product contamination, causing damage to health or even patient death
- Incorrect labels or printing on product containers, resulting in patients receiving the wrong medicine
- Inadequate or incorrect active ingredient, resulting in ineffective treatment or adverse effects.
Standard Operating Procedures (SOPs)
GMP covers all aspects of drug production, from the starting raw material, premises and equipment to the training and personal hygiene of staff.
Detailed, standard operating procedures (or SOPs) are essential for each process that could affect the quality of the finished product.
There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
