GMP Good Manufacturing Practices
A Manufacturing Practice with a Big Effect
Product manufacturing isn’t as simple as you might believe. There is a long and complex process that occurs before a product ends up on the shelf in front of you. And it’s not just manufacturing part either; or the design stage. A number of steps happen to ensure that each product that reaches the consumers is safe and does what it claims to do. These production and testing practices are vital for the protection of companies and customers. Each industry has their own versions (often more than one) and the pharmaceutical/medical industries use Good Manufacturing Practices to make sure their products are of the highest quality.
"As an ISO certified company we recognize and value GMP in the clients we serve." - Johnny Klemme, CEO
The basic goals of the GMP are to safeguard the health of patients while producing good quality medicine, medical devices and active pharmaceutical products. The GMP methods are well-regarded; a number of countries have passed laws to assure that medical products abide by GMP standards.
The origins of the GMP go back to the 1970s. Two years after the 1976 Medical Devices Amendment, the FDA issued the final draft of their GMP regulation. With the exception of reference and device updates; these regulations remain virtually unchanged.
There are quite a few guidelines but here are some of the basic principles:
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled and any changes are evaluated. The changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language.
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected and deviations are investigated/documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
A system is available for recalling any batch of a drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality are investigated, and appropriate measures are taken with respect to the defective drugs and also to prevent re occurrence.
These guidelines aren’t prescriptive instructions on how to manufacture drugs; they are steps that must be followed during manufacturing. The GMP is not just in use by the U.S. and the FDA; the World Health Organization (WHO) has a version of the GMP which they use as regulators in over 100 countries. The European Union (EU) also uses similar guidelines; as does Australia, Canada, Japan and Singapore.
K.L. Security operates under guidelines that can be considered the equivalent of the GMPs. We operate under the ISO9001:2008. This series of manufacturing and industry standards are similar to the GMP in that it aims to increase the quality and quantity of the major processes. They are put out by the International Organization for Standardization (ISO) a group that promulgates worldwide industrial, commercial and proprietary standards. We were the first company in our field to be certified in their 9001:2008 Quality Management standards. As such, we understand the importance of studying and applying standards and guidelines to the processes of manufacturing and management.
We advise you to investigate if your business or industry has such standards and if you fall under the GMP, then make sure you’re up to date for the safety and success of your company and customers.