How can you align your GMP principles with suppliers and distributors?

To align with GMP principles , we shall look at : - supplier qualification -supplier site audit -supplier agreement -quality agreements with the suppliers By aligning GMP principles with suppliers and distributors, organizations can ensure consistency, reliability, and compliance across the entire supply chain, to meet product quality and consumer safety.

Things that I found it useful for Supplier Qualificationsl: 1* Risk based categorization for Suppliers 2* Setting up acceptance criteria acc. to the risk and criticality of the materials supplied. 3* Reliance criteria should be checked and updated periodically

Other important aspect is to use risk-bases approach for Vendor audits and/or vendor qualification. A scorecard or a rating system can be implemented to rank suppliers based on risk. This typically includes annual basis review of patamaters like review of material complaints, delayed shipments, on time service, etc. The score can also be communicated officially to supplier and an action olan can be asked if the score and rating system is agreed mutually.

Building a trustworthy relationship with the suppliers is very essential to aligning our GMP requirements with theirs'. Further, there should be clear communications throughout the supply chain to convey the exact requirements.

Quality Agreements are essential to communicate requirements to suppliers and ensure the suppliers accept those requirements. Quality Agreements contain: meeting specific regulations, accepting external audits by the customer or regulator, product inspection requirements, notification of changes, maintaining quality management system by the supplier, complaints handling and timeline for corrective actions, and more.

We have to really understand who our suppliers are and what they know. If we don’t take the time to build relationships with the suppliers it will be difficult to communicate effectively and it will be difficult to have the level of trust we need to be open and collaborative, which is ideally what we need. You have to know what they know and what they don’t and then what they need to know and then communicate that in a way that makes it easy for them to understand. It’s not one size fits all so you have to meet each supplier “where they are”.

In my experience as Supplier Quality Engineer I have learned that these 2 things are crucial: 1) Have a Quality Agreement. 2) Have open communication and embrace ongoing supplier partnership. The last one has proven to be super powerful!!!

During any type of potential RFP process, building the RFP to outline the exact expectations in all aspects is incredibly important to the suppliers and distributors. understanding what you expect and being upfront about required items that will be audited will save you time and energy, and give you confidence that your GMP requirements are being followed.

From my previous experience in this concern we should deal with suppliers as they are partners and that the relationship with them is a mutually beneficial relationship, not just a transactional or fleeting relationship that will make implementation of GMPs more effective." -Also applying the concept of "Quality at Source" will be effective as you will apply quality programs and requested GMPs at the suppliers sites so you will improve the quality of incoming raw materials and reducing the waste, Inspections, and cost of the nonconforming materials and FG products - Set incident managemnt plan according to risk assessment and communicate the actions needed with suppliers will keep them align with your target GMPs level

By simply letting suppliers know what you expect from them and getting feedback about what they expect from you. From there any differences or difficulties can be mutually resolved if all are willing to be flexible and modify requirements if necessary.

1.Implement SLA: service level agreemen with your supplier(vendor) & mention all GMPs principles in it. Add 1 statement in contact with your supplier that SLA is an integrated & essential part of contract. 2. Do not forget other Pharmaceutical GXPx (X = Storage or Distribution or Documentation...etc.). 3. Arrange for 2nd party audit of your supplier to verify / validate GMP Implementation, if difficult send for him GMP survey /questionnaire . 4. Ask your supplier for his regulatory inspection report of GMP on his site

Clear communication, audits and inspection, qualification, written agreement, traceability and recall plans, Risk assessment, continuous monitoring and control

Agreements(quality or otherwise) are your make it or break it moments in this industry. A bad or insufficient contract can cause undo stress and huge financial loss. As well, it can crush your GMP compliance if not adhered to!

Also, consider qualifying more than just the primary vendor. It may become necessary to move to a secondary option while a resolution is approved for open deviations or a breach of the quality agreement. Investigations into either can take time, jeopardizing the ability to meet scheduling demands.

As part of supplier onboarding it is important to determine both the ongoing monitoring (think incoming inspection, monthly KPI review, SCAR for poor quality product/service, etc.) and periodic evaluation criteria that will be used to monitor performance. These should both be based on the risk of the supplier. Document what will be considered poor performance and what is considered a trend. Then ensure these expectations are included in the quality agreement so that you and the supplier are on the same page. Having all of this defined at the very beginning will give you everything you need to properly evaluate each supplier objectively

While this is extremely true it doesn't point out one of the key hurdles in everyday performance management of suppliers. The feedback loop has to be extremely quick and not allow non-conforming product received from suppliers to sit idle for long periods of time. It is often the case that internal reviews will be performed on the non-conforming products to decide a path forward. This time often eats up your ability to return product and fix issues before the next shipment is being produced.

Periodic Quality Reviews with critical suppliers are key for improvements. In those reviews, Quality metrics are reviewed in order to assess trends and decide on corrective actions. In addition, this is good opportunity to discuss customer-supplier relationship in terms of response time for requests, mutual projects, operating mechanisms to discuss and resolve issues. It is important to summarize such meetings with action items list and follow that list in future reviews. Top management should be part of those periodic reviews to ensure prioritize handling of hot issues by the teams.

This step is so important to building long lasting, mutually beneficial partnerships with key suppliers. Review aligned metrics periodically, you have to measure to know, communicate often and workshop areas of improvement with the supplier base. Them knowing and understanding their impact on your organization is key, and it's always great to partner with them and share knowledge and proposals where you've identified gaps that can improve their organization as well. Then everyone benefits.

-Increased Efficiency: Standardizing processes and quality standards across the supply chain streamlines operations and improves overall efficiency. This enables faster product development, shorter lead times, and better responsiveness to market demands. -Long-Term Sustainability: A commitment to GMP principles fosters a culture of continuous improvement and sustainability within your organization and throughout the supply chain. By prioritizing quality and compliance, you lay the foundation for long-term success and growth.

Aligning GMP principles with suppliers and distributors involves fostering a collaborative relationship to ensure product quality and safety. Begin by selecting partners who prioritize GMP, conduct audits, and establish clear quality agreements. Regular communication and training programs help align everyone with consistent standards. Implement shared documentation systems for transparency and traceability. Periodic quality reviews and continuous improvement initiatives foster a culture of compliance. Collaborate on risk assessments and promptly address deviations to maintain GMP integrity across the supply chain. This alignment ensures a cohesive approach to delivering high-quality products to consumers.

Ive leant through having regular supplier workshop forums and Sharing improvement initiatives, even simple tools like a basic 5S system and the importance of visual management, benefits both parties in the long term. Don't be afraid to share #best practices.

- Quality Assurance: Implement quality assurance measures throughout the supply chain to monitor and verify GMP compliance. This may include regular inspections, sampling, testing, and documentation review. - Risk Management: Identify and assess potential risks associated with suppliers and distributors that could impact product quality or safety. Develop risk mitigation strategies to address these risks and prevent issues from occurring. - Transparency and Traceability: Ensure transparency and traceability throughout the supply chain by maintaining accurate records, documentation, and tracking systems. This will enable you to quickly identify and address any deviations from GMP standards.