Good manufacturing practices (GMP) compliance is widely-accepted as the best way to conduct business, putting product quality first. 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. 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.
When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.
How we can help
We offer the following range of services:
GLP, GDP, and GMP compliance consulting
Policies, SOP, and Forms. We can also help you obtain approval from the international regulatory authorities.
Our experienced industry engineers can develop concept and detailed designs, around your production process ensuring full GMP compliance by careful project management and verification (validation) to ensure that the standards are met.
Quality Management Systems
We can help you create a Quality Management System from scratch, or bring your current system into compliance.
Technical Document Writing
We can help you write procedures and work instructions that your staff will actually use and can follow.
We run on-site or in-the-city classroom training on GDP, GLP, and GMP compliance, validation and documentation writing.