What is good manufacturing practice (GMP)?
Good manufacturing practice (GMP) is a concept that ensures medical products are consistently produced and controlled according to quality standards. It is designed to minimize the risks to the patient involved in any pharmaceutical production.
GMP constitutes the license to operate in pharmaceutical manufacturing and is a core condition worldwide. However, rules and interpretations differ from country to country and change frequently. Therefore, having fully trained experts at hand to help with the implementation of these rules is very important.
A basic outline of GMP
All guidelines follow a few basic principles:
- The production and distribution of the drugs must minimize any risk to their quality.
- Manufacturing facilities must maintain a clean and hygienic manufacturing area, including laboratories and storage.
- Manufacturing facility design, operating principles and environmental conditions must be controlled in order to prevent cross contamination of drug products, and to prevent cross contamination from labeled or unlabelled material or products.
- Manufacturing processes must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications. Any changes to the process are evaluated from a patient safety and product quality perspective and any approved change that may affect the quality of the drug are qualified or validated as necessary.
- Instructions and procedures must be written in clear and unambiguous language (Good Documentation Practices).
- Operators should be trained to carry out the production and control of products according to documented and approved procedures.
- Records should be made during manufacture and quality control, demonstrating that all the necessary steps required by the defined procedures and instructions were executed as defined, and that the specified quality attributes of the products have been met. Deviations are investigated and documented.
- The process should remain in a state of control throughout the product lifecycle and improvements done as needed.
- Records of manufacture (including distribution) are retained in a comprehensible and accessible format that can trace the complete history of a batch.
- A system must be available for recalling any batch from sale or supply.
- Complaints about marketed products should be examined, the causes of quality defects investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be applied during manufacturing. When a company is setting up its pharmaceutical quality system, manufacturing processes and control, there may be many ways to fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
Why is GMP so important in pharma engineering?
Poor quality drugs can be a disaster for both patients and governments from a health and a cost perspective. If companies cannot manufacture appropriate quality products due to GMP issues (the most common reason) there is a high risk of drug shortage, which unfortunately affects patients who cannot get their prescribed medication when they need it. The pharmaceutical industry has a responsibility to ensure a safe and sufficient supply of medicinal products, and this must be taken into consideration in pharma engineering and consulting projects from the outset.
Additionally, GMP can help boost pharmaceutical export opportunities. The majority of countries worldwide only accept the import and sale of medicines that have been manufactured to internationally recognized GMP standards.
Investing in GMP means investing in quality medicine. It saves costs, minimizes risks, and improves the standard of drugs worldwide.
How can NNE help with GMP?
With our certified and pharmaceutically trained professionals, NNE offers you seamless, smart and compliant GMP and compliance solutions. We have the expertise and international experience to handle the increasingly complex risk-based GMP demands from early conceptual design, qualification and validation to practical development implementation and execution of a pharmaceutical quality system.
External resources
1. FDA
