How do you share knowledge with your GMP contract manufacturers?

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If you outsource any part of your GMP operations to contract manufacturers, you know how important it is to share knowledge with them. Knowledge sharing is not only about transferring documents and data, but also about building trust, communication, and collaboration. In this article, you will learn some practical tips on how to share knowledge with your GMP contract manufacturers effectively and efficiently.

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Idowu Olukayode

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Keith Bowen

1 Why share knowledge?

Knowledge sharing is essential for ensuring quality, compliance, and efficiency in your GMP outsourcing relationships. Through sharing knowledge, you can align your expectations and requirements with your contract manufacturers, reduce errors and risks in your processes and products, and improve your performance and productivity by learning from each other's best practices. Additionally, knowledge sharing can foster innovation and continuous improvement by exchanging feedback and ideas, as well as enhance your reputation and credibility as a reliable and responsible partner.

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Idowu Olukayode
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I have found GMP knowledge sharing to be a means of fostering collaboration by looking for common ground and enhancing mutual interdependence towards achieving shared goals

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2 What to share?

The type and amount of knowledge you share with your contract manufacturers depends on several factors, such as the scope, complexity, and duration of your outsourcing project, the level of trust and maturity of your relationship, and the regulatory and contractual obligations you have. Generally speaking, there are four categories of knowledge you should consider sharing: technical knowledge (e.g. specifications, standards, methods, procedures, protocols, validation, testing, and troubleshooting related to products and processes), regulatory knowledge (laws, regulations, guidelines, authorities that apply to products and processes; documentation audits; inspections; reporting), business knowledge (strategic, operational, financial aspects of the project; objectives; milestones; deliverables; roles; responsibilities; communication; reporting; budget; payment), and cultural knowledge (values; norms; beliefs; behaviors that shape organizational culture).

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Idowu Olukayode
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Also to be shared are the metrics to measure the third party compliance to these requirements, and how their compliance affects the maintenance of the existing contractual agreement.

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3 How to share?

Sharing knowledge with contract manufacturers can have a major influence on the quality and effectiveness of knowledge transfer. To ensure that the knowledge is accurate, complete, and up-to-date, you should create clear and consistent standards for creating, storing, accessing, updating, and verifying it. Additionally, you should use multiple channels and formats to communicate and document the knowledge, such as emails, phone calls, webinars, workshops, checklists, databases, and dashboards. Furthermore, you should encourage feedback and questions from contract manufacturers to cultivate a culture of learning and collaboration. Lastly, monitoring and evaluating the results of your outsourcing project can help you measure the value of your knowledge sharing.

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Keith Bowen
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A standardised product definition via a cloud portal where product instance data can subsequently be entered and attachments uploaded. It simplifies the interpretation effort and having to digest 50 to 100 documents. Knowledge requires additional collaboration on top.

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Lewis Shipp

Digital CMC @ QbDVision | Enabling End-To-End Product Lifecycle Management for Global Pharma/Biotech Organisations
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In BioPharma, all orgs. consider working with (& sharing knowledge with) C(D)MOs at one point. The challenge here, is that this "knowledge" is shared via documents (as its defined in documents to begin with). Take a simple process description report for example, developed by the sponsor, which has a tonne of info. trapped within regarding Process UOs, Steps, Parameters etc. that any C(D)MO must comb through & figure out to begin development/manufacturing. Not to mention an image of a manually generated Visio Process Flow Map. A very cumbersome process to say the least.

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4 When to share?

When it comes to knowledge sharing, timing is key for maximizing benefits and minimizing challenges. Thus, you should start sharing knowledge with your contract manufacturers early in the outsourcing project and continue to do so throughout its lifecycle. It's important to only share the knowledge that is relevant and necessary for their tasks and roles, and that complies with contractual and regulatory obligations. Furthermore, you should ensure that knowledge is shared at the right level of granularity and abstraction for your contract manufacturers, depending on their background, experience, and capabilities.

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Keith Bowen
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As early as possible. Tech transfer can take a long time and in some industries, it is handled as a project. To get really good at it requires a dedicated team rather than a project team where the team is assembled and then subsequently disbanded.

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5 Who to share with?

To ensure successful knowledge sharing, it is important to identify and involve the right stakeholders from both sides, such as managers, engineers, technicians, quality assurance, regulatory affairs, and logistics. Additionally, building trust and rapport with your contract manufacturers by being transparent, respectful, supportive, and responsive will enhance the quality and effectiveness of your knowledge sharing. It is also beneficial to recognize and reward your contract manufacturers for their knowledge sharing efforts and achievements by providing feedback, praise, recognition, incentives, or opportunities.

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