In a GMP environment documentation needs to meet certain requirements to ensure product quality and product safety. If an instruction or record is poorly documented, then the manufacture or Quality assurance/control of a product can be negatively impacted, potentially reducing patient safety.
The GMP regulations from PIC/S, FDA and EU all include mandatory sections on documentation.
Documentation provides both:
Information on when, where, who, why and how to complete tasks, and Evidence proving that the tasks have been completed as they should be.
Consequently, the standard of documentation within a company can directly impact the level of success in manufacturing quality products that are safe as well as success during audit situations.
The basics of GDP
To meet industry standards, it is critical that all documentation follows GDP when it affects:
GMP processes Material or product identity, quality, purity, strength and safety The validated state of GMP product manufacture, facilities, equipment, computer systems and testing methods.
It is recommended that your company has a policy or procedure outlining the expected GDP standards, particularly for those requirements that may be unique to your company.
About LCGC LABS We are a professional consultancy offering product registration, engineering, validation, and regulatory compliance solutions from concept development, feasibility studies, scale up, engineering design, project management to the final product regulatory approval and GMP compliance certification.
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.
Engineering 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.
Training We run on-site or in-the-city classroom training on GDP, GLP, and GMP compliance, validation and documentation writing.