Would George, Abe, and Teddy be good at GMP?
There is no doubt that our past Presidents upheld certain principles that helped shape our country but would past Presidents have been good at GMP? Good Manufacturing Practice (GMP) includes 10 basic principles which help manufacturers establish and follow a quality assurance program to help ensure their products are safe and effective.
"Important principles may, and must, be inflexible." Abraham Lincoln
The 10 Principles of GMP:
- Develop standard operating procedures and work instructions. It is critical that clear, concise, and logical standard operating procedures are established to ensure controlled and consistent performance and quality.
- Follow procedures to ensure consistent quality. It is important to follow established procedures precisely. Following procedures ensures that the outcome is consistent, not only in your own work but is consistent across everyone that are performing the work.
- Document work promptly and accurately for compliance and traceability. Document work at the time it’s being performed by entering complete information to ensure record integrity. If it’s not documented, it didn’t happen. All entries should be signed or initialed either by a 21 CFR Part 11 compliant electronic signature or with a physical signature.
- Validate. Validation proves a process works consistently and can consistently produce the outcome that it was designed to do. It is important that validation activities are well defined and that a validation plan is followed. It is equally important that a robust Change Management program be in place for evaluating and documenting any changes or updates to validated processes, equipment, or systems. The Change Management program should also evaluate if the impact of the change would require re-validation.
- The design and layout of the facility and equipment should allow for a flow of work that is logical in design to ensure safety, productivity, and quality. Facility design, layout, and location of equipment and supplies should be well planned to allow the flow of work throughout the facility to be performed safely, prevent unnecessary stagnation, and reinforce quality.
- Properly maintaining the facility and equipment. It is important to have a procedure for maintenance of facilities and equipment and follow the planned maintenance schedule. This not only reduces risk but also maintains the “validated state” of the facility or equipment. Don’t forget to document all maintenance activities!
- Clearly define, develop and demonstrate job competence. Everyone’s job is important and can affect the overall quality of a product, some more crucially than others. That is why it is important that training and demonstration of competence be defined for each role.
- Protect against contamination. Just as it is important to have procedures and schedules for facility and equipment maintenance, it is equally important to have procedures and a schedule for the cleaning, sanitization, and sometimes sterilization of a facility and equipment. A routine schedule for testing and monitoring should be put in place to ensure the level of cleanliness required is being met.
- Build quality rather than test quality. The focus should be on all items that can potentially influence the quality of a product. This includes personnel, facilities and equipment, raw materials, processes, and in-process controls. Good manufacturing practice starts from the point of input and should continue in an ongoing manner on a continuous basis.
- Conduct planned and periodic audits. While the FDA will conduct external audits to determine an organization is compliant with GMPs, it is important to perform scheduled and routine internal audits to evaluate and assess GMP competencies and compliance.
Need help implementing, maintaining, training or auditing GMPs? Contact Labtopia today for all your GMP needs!