Quality system management for CDMOs
6th April 2020
By Virginie Maurel, QA Manager and Etienne Baco, Business Manager, La Mesta Chime Fine
The evolution of the CDMO market Fine chemistry CDMOs have been histor
The evolution of the CDMO market
Fine chemistry CDMOs have been historically involved in supporting the pharmaceutical sector but, over the years, they changed their business practices by following the identified needs of customers and the market, as well as by modifying their own services and technologies offerings. Thus, CDMO portfolios were often widely extended to serve players in such various industrial markets as food flavours, food supplements, fragances, cosmetics, photographic chemicals, and agrochemistry, among others. Each customer and / or product, subject or not to regulations, has its own specific quality standards that need to be applied, and as a CDMO La Mesta Chimie Fine has to comply with these too.
Growing numbers of requirements in various industries
Over the past 10 years, in addition to the pharmaceutical industry’s large number of regulatory requirements, the CDMO sector has had to take into account the increasing regulatory standards of the big players in cosmetics, flavours & fragances, photographic chemicals, and so on. The aim of all companies in these sectors is to always guarantee the best quality and traceability of products for their own customers, as these products are actually used by the wider public. Requests for complying with various standards have therefore to be fullfilled. In addition to ISO9001 and GMP Part II complaince, La Mesta decided to apply for FSSC22000 certification (Food Safety System Certification), which it recently obtained.
The genesis of a global quality system
这一最新举措意味着公司必须添加ress the following issues: How to implement and maintain a Quality System meeting all the requirements without completely disrupting the one already in place How to develop, apply and maintain a Quality System in an appropriate and proportionate manner for the highest-regulated products without making any non-quality, for the lowest-regulated products without making any ‘over-quality’, and without affecting the size and diversity of the company’s activities and standards. This might appear to be a tedious task and be difficult to perform in an industrial context but what if the benefits that could be accrued from an understanding of these standards and from experience of the company’s own practices could lead to a more pragmatic approach and the development of a ‘global’ Quality System?
La Mesta therefore decided to take a threepronged approach: a global Quality System approach; risk assessment ; and pragmatic adjustment of procedures and practices to achieve a practical Quality System satisfying the company’s needs.
Quality System approach
First, the requirements of ISO9001, FSSC22000 (including ISO22000) and the recent ICHQ10 guideline (BPF Part II) were combined to produce a robust Quality System, an essential tool enabling senior management to measure performance and drive the company’s strategy and continuous performance improvement.
Information enabling risk assessment
Risk management is an important part of La Mesta’s activity in the areas of SHE, quality, business and so on, but the continuous search for zero risk can be very expensive and the need for the company to be profitable forced it to devote its efforts to essential goals. Thus, in the area of quality in its pharmaceutical and food industry activities, risk-taking was limited by the precautionary principle of patient or consumer safety. ICHQ9 principles and HACCP methodology applied, respectively, in these two highly regulated industries helped la Mesta to identify action paths that would enable it to put in place its global system. Company management therefore internally shared knowledge of regulatory requirements, processes, technology, and products to develop robust and efficient ways of managing qualityrisks.
Pragmatic approach to quality
Instructions and practices
The quality of a product is guaranteed by the manufacturing practices that are in place. La Mesta therefore adapted its practices based on risk assessment, keeping in mind regulatory and customer requirements, as well as the final end use of the product, with a focus on modifying instructions and control levels to meet these requirements.
Knowledge of processes and regulatory and customer requirementsis is essentialin order to adapt practices and to specify clear instructions. Staff training and communication are also crucial. La Mesta therefore differentiated its documentation using different colours and logos to identify what type of product they referred to and the company also set up a simpler product release process that could be used where applicable. This pragmatic approach led to the achievement of exactly just the right level of quality for each product and the correct application of the company’s strengths, resources, and time, producing a QualitySystem designed to meet regulatory and customer requirements and in which staff, and particularly operational staff, could see how they contribute to this. A quality culture has therefore become and is becoming even more important in the company.
To summarize: a fine chemistry CDMO may be seen as a toolbox with the ability to perform various projects thanks to its operational and technical agility, its compliance with increasing standards being simply an additional tool that meets the expectations of customers and satisfies regulations. However, even in the area of Quality, CDMOs have to show agility in applying the relevant resources to meet the regulatory requirements of an individual project. Knowledge, pragmatism, risk assessment and a quality culture are the keys to succcess in this field and a Quality System should become a major asset that enables CDMOs to win business, perform successfully and remain attractive to customers in the markets it supplies.