What are the most important GMP quality management resources for contract manufacturers?

A strong core QMS which gives flexibility with respect to phase-appropriate GMPs, risk-based decision making and adaptable to accomodate client needs for their manufacturing processses. The CMO should also have a detailed quality agreement specific to client needs and address general working expectations with clarity. CMO should have strengthened internal audit/self-inspection program to make them ready to handle client audits/due diligence visits with short notice. CMO should have SMEs in relevant areas and strong GMP/On-the-job training programs which are interactive (not check-list driven) and make operators aware of client process/product requirements. Finally, CMO should have expertise to monitor regulatory landscape / new regulations.

Contract Manufacturers (CMO) should have their Quality Management System set up in no different way compared to any other Pharmaceutical/GMP Manufacturer. In my experience in managing accounts of CMO, I observed it would be a win win situation for both the parties if there is a level of trust and the Quality Agreement spells out the expectations in details. The best resource to support the CMO would be the client itself. If the client is a firmly established big company, they will already have excellent QMS SOPs set up for their own use. The client would expect the same (or a quality standard, which is even better, more robust) to be followed during handling of their product.

In my experience, For contract manufacturers, a crucial resource for quality management is the official GMP guidelines and regulations. These rules outline the least you need to do for things like building, operating, and maintaining your manufacturing facilities. They cover equipment, staff, processes, and paperwork. It's important for contract manufacturers to know and follow these rules in the countries and regions they work in, as well as where their clients are. Keeping up with any changes to these guidelines is also key to staying compliant.

Companies that outsource their manufacturing to a CDMO service provider are going to have to outsource lots of their quality and CMC efforts. A strong quality agreement is then needed to ensure that all the requirements (CFR 21 Part 11, or other) are going to need coverage. Ensuring this is the responsibility of the owner of the product, ensuring enough quality is built into the statements of work will be a challenge when dealing with project management on both sides.

In my opinion, contract manufacturers need to stay updated on GMP guidelines and local regulations, have a detailed process documents ensure quality control, well-train their staff following GMP principles, maintain GMP-compliant facilities, perform rigorous raw material checks and audits, track production in details across the supply chain, have a clear testing protocols at every stage, have solid systems to address safety and quality risks, regularly review to update processes, continuously improve their process, have a detailed records for accountability, and finally perform regular internal checks for GMP compliance.

What I have seen , Contract manufacturers deal with regular GMP audits and inspections, where others check how well they're following the GMP rules. These assessments can be done by clients, external auditors, or regulators. The goal is to find and fix any issues in their quality system and show they can meet GMP standards. To prepare, contract manufacturers should do self-checks, review their paperwork, train their staff, and fix things that need fixing before the audits or inspections happen. It's a way to stay on top of things and prove their commitment to quality.

One of the most effective ways to prepare for an inspection is to perform a mock inspection. Carry it out to ensure everyone is prepared and understands how a real GMP audit will be performed. Allow individuals without significant experience to take part. Test any areas of potential weakness. Trial the front room, back room set up to ensure everyone understands their roles and responsibilities. At the end of the mock audit, discuss what went well and what needs improvement.

A mindset of “audit ready every day” across the whole organisation is essential, from receptionists to senior managers as well as the Quality department. Readiness for unannounced regulatory audits is critical.

Another suggested practice is using the Gap Analysis, preparing your evidence of how you meet the standard and having the information readily available. This way, when regulations are created or updated, the evidence can be as well. This practice contributes to a constant state of readiness.

Il faut aussi mettre en place un système de surveillance continue des prestataires afin de s'assurer du respect des exigences convenues precisant aussi les actions a entreprendre en cas de non respect, et par la suite un système d'évaluation qui permet de classifier les prestataires en catégorie et pourvoir se décider de les retenir ou ne plus travailler avec.

For contract manufacturers, another crucial resource is giving their staff regular GMP training and education. This ongoing process ensures that everyone working on making products knows what they're doing according to GMP rules. Training covers the basic GMP principles and practices, as well as the specific details of the products and processes they're dealing with. It's important to keep this training updated to match any changes in GMP standards or how things are done in manufacturing. This way, everyone stays informed and does their jobs the right way.

With education and understanding why you follow GMPs, you can have success. Without the why, GMPs will not make sense and people will not follow them.

Una utilidad que he encontrado a nivel profesional y que me resulta interesante es la capacitación y educación GMP pues de esa forma se puede garantizar que la tarea de los fabricantes por contrato no solo lo realizen por obligacion, sino que tomen conciencia para alcanzar los objetivos con eficiencia

Il faut tout d'abord bien rédiger le contrat avec son prestataire, lui tenir au courant de toutes les exigences en matières de BPF et qu'il en soit d'accord à appliquer et ainsi assurer son application par tous les intervenants de l'entreprise. Il faut former les équipes en interne pour pouvoir bien gérer le déroulement des prestations dans les bonnes conditions d'hygiène et de fabrication, et de pouvoir détecter toute déviation ou non respect de la part des intervenants et savoir agir efficacement.

To this point, it's worth mentioning the unique position of contract manufacturers: most of the times they can access their customers knowledge in QARA (it is the best interest of both to share best practices in this area) and organising benchmark visit and inviting trainers could give a unique view about the expectations to follow.

It’s good practice in my experience to track how quickly any auditee can provide all that documentation as you don’t want to make an inspector wait, they have lots to cover and could be suspicious if it takes too long to find something. Having a simple xl tracker works well, especially by sharing it with colleagues (eg SharePoint) so you can all co-edit and add who asked what and when, then monitor who provided the info, at what time and was the documentation satisfactory. And if there was something amiss, start putting a plan to fix it, you might be able to remediate by the end of the inspection and demonstrate to the inspector that you are addressing issues seriously, even minor things.

I love documents. Poor manufacturers see documents as a necessary compliance burden, something to get out of the way so they can focus on making products. Good manufacturers see the document not just as "evidence and proof" but as a tool to go through the thought-work. How are you going to make that product? How are you going to set up that line? Good documents are the inputs to answer those questions, not the outputs. As a bonus, good documents satisfy auditors quickly.

With over 2 decades of quality management experience, manufacturing, construction and education, I have seen the importance of a document management system (DMS). Documentation and records provide organisations with the opportunity to not only document their processes and evidence of compliance, but also enables evidence-based decision making. A DMS supports evidence-based training and onboarding. It also allows for the development of access controls and security features that offer tangible measures to foster continual improvement and mitigate risks through data-driven insights.

Il faut tout d'abord bien rédiger le contrat avec son prestataire, lui tenir au courant de toutes les exigences en matières de BPF et qu'il en soit d'accord à appliquer et ainsi assurer son application par tous les intervenants de l'entreprise. Il faut aussi mettre en place un système de surveillance (contr?le) continue des prestataires afin de s'assurer du respect des exigences convenues precisant aussi les actions a entreprendre en cas de non respect, et par la suite un système d'évaluation qui permet de classifier les prestataires en catégorie et pourvoir se décider de les retenir ou ne plus travailler avec.

In maintaining compliance ,the issue of data integrity will crop up.Whether data is paper,electronic or hybrid there is need to have traceability. Recording data as you are performing a task (contemporaneous recording) prevents the user from forgetting or making mistakes.

My recommendation on software is to find job specific software. Purchasing QMS software may be good for one application (document control) but may lack in another(metric dashboards). One useful type of software is any data software that allows for submitting data, and provides an interpretive comparison analysis. This way, all GMP validation can be assessed equally.

The key Resources for GMP should include -Full access for updated global GMP guideline -Access to global regulatory affairs (ISO/ICH/FDA/EMA/TGA..) -Accurate and competent qualified person -Risk Assessment tools to utilize this Art -Internal and External Auditing periodically

All suggestions good but the focus must be on results. The right tool to get the desired result. A hammer drives in nails you don't use a saw. Understanding your customers needs and gaps both spoken and unspoken is critical and providing a quality product on time at a fair price is critical and if you don't understand your team your customer and goals every effort has been wasted. So understand your customers first . Then your capabilities.

Las auditorías son procesos que nos permiten tener un diagnóstico bastante certero del cumplimiento de lo que estamos evaluando, siempre tenemos que tener un alcance, un estándar o parámetro en revisión y escalas de cumplimiento. Todas las desviaciones detectadas deberán ser trabajadas para subsanarlas.

L'un des outils pouvant être utilisé dans le processus de l'apprentissage et de l’amélioration de continue de la qualité est la roue de deming ou PDCA. Cette démarche basée sur les données doit impliquer le personnel.

Good GMP Quality Management resources for contract manufacturers would be: ? Access of Regulatory guidelines ? Competent personnel ? Qualified good machines and utilities ? Periodic internal and external reviews ? Robust 3P - Process, Product and People ? Good Documentation Practices ? Invest in latest online software Most important is self motivated transparent leadership ???

Key resources for GMP and quality management in contract manufacturing in an SME context include FDA's detailed guidance documents, globally accepted ICH guidelines (e.g., ICH Q7), and ISO standards (ISO 9001, ISO 13485). Continuous improvement of Quality management systems and adaptation to industry-specific regulations are key to success.

Mainly, resources should prioritize guidelines from regulatory agencies like the FDA, EMA, or WHO. Industry publications, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) documents, and GMP training programs are essential. Additionally, leveraging collaboration with experienced consultants and engaging in industry forums ensures compliance and fosters a commitment to high-quality standards.

Die hier genannten Themen treffen auf alle Firmen der Pharmaindustrie zu. Lohnhersteller stehen vor allem in einem starken Wettbewerb und haben in der Regel hohen Kostendruck und kleine Margen. Nur wenige Firmen haben die M?glichkeit Alleinstellungsmerkmale zu entwickeln. Eine Kostenführerschaft geht oft mit Qualit?tseinbussen einher, d.h. die Risiken sind für Auftraggeber h?her. Daher sollte das oberste Ziel sein, eine operative Excellence zu erreichen und konsequent zu digitalisieren.

Quality Management Systems (QMS) ISO 9001 also provides a framework for a quality management system that can be integrated with GMP requirements