According to the ICH guidelines, risk is defined as a combination of the probability of injury and the severity of the damage1. To manage risk, drug development and production depend on effective risk quality management (QM) – a systematic process of assessing, controlling, communicating and verifying patient risks and drug quality throughout the product lifecycle. An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. In May, the Food and Drug Administration (FDA) released a new draft industry guidelines entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (1). I like the way the title rolls out of the tongue, don`t I? You may be wondering what this has to do with spectroscopy, or even an analytical laboratory, which is a fair question. The answer is on page 1 of the document, which defines the term “manufacturing,” including processing, packaging, breeding, labelling, control and operation of the “quality unit.” Is the light bulb already on? The testing and operation of the quality unit – could these terms mean that a laboratory is involved? Yes, I do. Change is an integral part of the quality system, which aims to identify and implement innovations and quality improvements throughout the product lifecycle. In order to control changes, any changes that may affect quality, safety and effectiveness should be subject to a review, evaluation, implementation and audit process. This includes any changes to the product; The equipment, instrumentation and process used to manufacture them; and the installation in which it is made. Change management also applies to documentation, computer systems, training and administrative registration. In the guide to the quality agreement (1), the FDA states that contract laboratories are subject to GMP regulations and presents two specific scenarios. You can find them here in a preview, see the instructions for detailed discussion.
According to the FDA (1), a quality agreement includes at least the following sections: To achieve the client`s objectives, contract development and manufacturing organizations (LCOs) typically work at multiple geographic locations, each of which can be controlled by a large number of different agencies. Centres of Excellence ensure that the quality assurance system remains the same globally. Quality system improvements are being implemented around the world through contributions from Center of Excellence members around the world to maintain inter-local coherence. A particular site can be known as a center of excellence for a certain manufacturing capacity or perform a specific quality assurance system function. This underlines the importance of integrating local-specific quality requirements into the global quality system. Only in case you missed it above, the contract lab must generate complete data, such as the GMP request for all the work it does. This includes both the paper and electronic recordings I mentioned in a previous column entitled “Focusing on Quality” (10).