GMP, or Good Manufacturing Practices are FDA regulated codes that ensure that all foods, drugs, and medical devices are pure, safe and effective. The primary goal of GMP is that manufacturing processes for all foods, drugs, and medical devices operate in a state of control. This state of control acts as a filter to help eliminate product contamination, mix-ups, and errors.
GMP requires that you say what you are going to do, do what you say, and document what you did. Complete traceability is necessary for the entire production process, from incoming raw material to the shipping of the final product.
GMP promotes building quality into the product up front, so the customers' requirements are met the first time, every time.

"The Commandments of GMP"

1 Document procedures.
Each manufacturer must have written documents describing the procedures of the manufacturing process for finished product. In addition, the device master record is a controlled document that outlines the production specifications for a food, drug, or medical device. An FDA inspector will challenge the effectiveness of the device master record to determine if the manufacturing process is operating in a state of control.

2 Follow written procedures.
If the procedure is necessary, it must be done. If the procedure changes, this change must be documented. Be specific in written documents and ensure they are understood and followed.

3 Document work.
All production records must be written, signed, and dated by an authorized person. These records are part of the device history record, which ensures that each device manufactured can be traced. Each output (finished product) must be traceable to each input (raw material). Records must be retained for the expected life of the product.

4 Design and build proper facilities and equipment.
Manufacturing facilities shall be of suitable design, contain sufficient space to prevent mix-ups, and assure orderly handling of all product components. Equipment used in the manufacturing process shall be properly designed, constructed, and installed to adequately produce the desired product.

5 Maintain facilities and equipment.
Facility maintenance ensures that product contamination will be kept to a minimum, handling procedures will be orderly, and mix-ups will be avoided. Facility maintenance encompasses equipment preventative maintenance, equipment calibration, and environmental control.

6 Be competent.
All temporary and permanent employees must be qualified and have the necessary experience to perform their jobs. Training both old and new employees is paramount to competence. Qualifications, experience, and training of all employees must be documented.

7 Control for quality.
There must be quality control for all manufacturing processes. Important factors to meeting customers' requirements are: control changes, quality management independent of production management, checking, verifying, approving, and documenting.

8 Maintain a standard of cleanliness.
Define and document the level of cleanliness necessary to make a quality food, drug, or medical device. Maintain a cleaning schedule and document the cleaning activity.