Following the 10 Principles of GMP is important for ensuring any product which is released to the market has undergone stringent testing and meets production standards deemed necessary for patient safety.
It is therefore important that all manufacturers understand these principles to provide them with a starting point when it comes to establishing their quality system which will meet industry standards.
Here are the 10 principles of GMP to ensure product safety:
1. Containment Controls: Every step in the process is defined and controlled to minimize contamination risks.
2. Equipment Design: Equipment must be properly designed with factors such as hygiene in mind so that it can function efficiently and safely for its intended use. The equipment must also be able to withstand the conditions, which it is expected to be used and must not contain any system that might drop the product quality.
3. Validation: Equipment and processes must be validated to ensure their design is met, which will help you achieve the final goal of producing safe and effective products. Validation must include all aspects of the process from cleaning to validation protocols. It is important to note that the design space is not limited to what is documented in the validation protocol.
Process validation will focus on proving that a process can consistently produce a product with the desired quality and purity.
Equipment validation will focus on proving that a piece of equipment can consistently produce the product with desired quality and purity.
4. Master Production Records (MPRs): Master production records must be developed and implemented as a means to demonstrate that each step of the process has been completed and that the product meets its specification for quality and purity. The MPR must include all aspects of the process from cleaning in the process to when the product is considered finished.
5. Equipment and Utensils: All equipment used in manufacturing, packaging, labeling, transportation must be identified, designed, and validated for its intended use. Equipment will also need to be cleaned before each production run or lot to prevent cross-contamination risks. There must be no areas on equipment that might result in contamination such as cracks or open seams.
It is important to note that utensils such as tools, funnels, and stirring rods will also need to be categorized by their designated use. They must not come in contact with the final product at any time during their lifetime and should be dedicated for a specific use.
6. Compounds, Containers, and Closures: This means that all compounds must go through purification, analysis, and testing steps to ensure the compound has the correct properties needed for your product before it is filled into its final container (vials, syringes).
These issues must be addressed at the design stage of the product to prevent contamination risks during filling or packaging. All package components must be tested for compatibility with their intended contents as well as each other.
The container closure system must provide an effective seal against contamination throughout its lifetime until the use by the patient. It is important to note that if there are any leaks in the container closure system, they should not affect the quality, safety, and effectiveness of the product.
7. Hold and Storage: This means that all products need to be held in a specific area until needed before packaging or filling into their final container (vials, syringe).
It is important that if any hold time has been exceeded, you must amend the documents accordingly. It is important to note that if there are any concerns regarding storage conditions, they should not affect the quality, safety, and effectiveness of the product.
8. Production Records: All steps in the manufacturing process including methods used to ensure acceptable quality have to be documented thoroughly for each batch or lot produced so that it can provide evidence during an inspection at any time by regulators. Production records will also need to accompany the product from the time it is received into manufacturing to its release.
9. Packaging and Labeling: It is important that all labeling must be clear, concise, legible, appropriate to its intended use, and include both product name(s), as well as the expiration date of the product, has been established.
It is also important that packaging components are manufactured under controlled conditions where there are no issues with contamination or recalls due to their potential impact on the quality of your final product.
All labels will need to have a barcode that can prove their authenticity at any given time.
The Quality Unit must approve all labels before they are used for production purposes. You must not only rely on primary manufacturer’s labels as they may not always be accurate.
10. Documentation: There are also documentation requirements associated with GMP; for example, some information should be documented in batch records or standard operating procedures (SOPs).
These principles aim to ensure pharmaceutical products meet their specifications and have been produced under GMP conditions from appropriate starting materials with the correct controls throughout processing. In other words, it ensures that each product has been made correctly every step of the way.