GMP stands for Good Manufacturing Practices. It is a set of guidelines and regulations to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use. This includes guidelines for the design, monitoring, and control of manufacturing processes, as well as quality control testing procedures. GMP compliance is mandatory for all pharmaceutical manufacturers in order to ensure the safety and efficacy of their products.
Areas of GMP
There are several areas of GMP, but the five main components are called the 5P’s:
1. Personnel (or People)
The manufacturer has qualified and trained personnel who are responsible for the following procedures and processes, and clear roles and responsibilities.
2. Premises and Equipment
The manufacturer has appropriate premises and equipment that are designed, constructed, maintained and cleaned to prevent any contamination or mix-up of products. Equipment is qualified and calibrated, there are records and procedures in place.
The manufacturer maintains accurate and complete records of all aspects of the manufacturing process. This identifies critical steps and are clearly defined and recorded. Production processes have to be validated.
The manufacturer documents and records procedures which cover all critical processes. Deviations are reported and investigated. Change control procedures are robust and clearly recorded.
GMP requires that the manufacturer has a system of quality control, which includes the specifications and testing methodology of raw materials, intermediates, and finished products to ensure that they meet the required specifications. Methods are also followed for sampling and stability testing. Methods have to be validated.
Why is GMP important?
GMP is important because it ensures that products are produced in a defined and consistent manner and controlled to a high quality standard. This helps to protect the patient from potentially dangerous products and to ensure that the pharmaceutical products are safe and effective for their intended use.
GMP guidelines and regulations cover all aspects of the manufacturing process, including the design and construction of facilities, the training of personnel, the establishment of quality control procedures, and the testing of finished products. Compliance with GMP helps to ensure that pharmaceutical products meet the required standards of purity, potency, and quality, and that they are free from contaminants and other harmful substances.
What about GxP?
Sometimes companies refer to GxP. In this case the ‘x’ stands for the particular field like manufacturing (GMP), laboratory (GLP), distribution (GDP) etc.
What about cGMP?
cGMP stands for current good manufacturing practice. This is an update version of GMP, which ensure the manufacturing process and technology are up-to-date.
FDA cGMP Guidelines for Pharmaceutical Industry
- 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
- 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
Note: While in the design phase of a new GMP manufacturing facility, there are 5 items to consider:
- Ideally, design the facility around the manufacturing process.
- Consider unidirectional flow of material, intermediates, product, personnel and waste.
- A suitable design and construction should facilitate good sanitation, while also providing adequate space for process, validation, maintenance, and calibration activities.
- The design should consider future growth to maintain correct flows, and keep cleaning and sanitation in mind.
- Finally, design with maximum protection against entry of insects, birds and animals.
In GMP manufacturing, consultants and contract staff should be qualified for the services being provided:
- With records to prove qualifications
- Have adequate training performed before undertaking tasks
- With their training records retained
- Data Integrity in Pharmaceutical Industry
- Batch Production Record in Pharmaceutical Industry
- Difference Between GMP and cGMP
Resource Person: Hassan Hussein