Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
The standard supply chain within the Pharmaceutical industry is complicated. It is subject to strict regulations and industry best practice standards. In addition to heavy oversight from regulators, industry, and consumers, the intricate structure of the Pharmaceutical supply chain, as well was its global nature, add to its complexity. The emergence of India and China, where there are now many excipient, API, and CMO suppliers, exemplify that global nature. This expansion on the global stage adds another serious layer of complexity. With distance, comes risk — the risk that something could go wrong not only in manufacturing, but in transit.
With so much at stake, a manufacturing organization must focus its vision from the very beginning.
Understanding Regulations and Standards
There are many regulations and standards to reference regarding the Pharmaceutical supply chain. Below is a list of just a few that cite the need to start at the beginning by first knowing your suppliers, and their suppliers.
- ISO 9001:2015 Section 8.4
- ICH Q10 – Pharmaceutical Quality System (section 2.7)
- ICH Q9 – Annex II.5 Quality Risk Management as a Part of Materials Management
- FDA Guidance for Industry – Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
- 21 CFR Part 211
- Active Pharmaceutical Ingredients Committee (APIC)
ICH Q10 requires the use of approved suppliers and a defined supply chain. ISO 9001:2015 section 8.4 states that the organization shall determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. It also states that the organization shall retain documented information of these activities and any necessary actions arising from the evaluations.
Without going into the text of each regulation, it suffices to say that these regulations and standards, echo the same base requirement: the need to manage the evaluation, selection, management, and decommissioning of Suppliers which results in an Approved Supplier List (ASL).
It Starts with Supplier Life Cycle Control
The creation of an ASL isn’t an annual event. It is the result of a continuous supplier life cycle control process. To understand fully the criticality of engaging Supplier Life Cycle control, look to one of the guidances which makes the case for a defined supply chain very clear. FDA’s Guidance for Industry – Contract Manufacturing Arrangements for Drugs: Quality Agreements states, “In all cases, the Owner is responsible for assuring that drugs introduced for interstate commerce are neither adulterated nor misbranded…”. In other words, regardless of the “source” of a problem, it’s the brand owners’ problem.
For this reason alone, it is critical that each of your suppliers is properly evaluated, allowing your organization to understand each of these respective operational attributes:
- What are their business systems?
- Are they financially stable?
- What do the financial analysts and market have to say about them?
- What percent of their sales is the product or resource you need?
- Do they have a quality system?
- What metrics do they calculate and trend?
- Do they have any certifications?
- Have there been any regulatory compliance findings against the organization?
- What is the capacity of the supplier’s operations?
- What technology do they use?
- Do they have a good reputation in the industry?
- Are their product costs and distribution costs in line with the competition and your budget?
- Physically, where are they located, and who are your points of contact?
While this list is not entirely inclusive, one can see that the purpose of a supplier evaluation process is indeed to assess and assign supplier risk. It is equally important to assess the process your suppliers use to evaluate, select and monitor their suppliers. Organizations must track and understand where raw materials, APIs, and intermediates are coming from for a fully defined supply chain.
Defined Supply Chain’s Purpose
When something goes wrong in the supply chain, regardless of where it went wrong in the supply chain, it impacts your organization and the patients it serves. Having a well-defined supply chain is ultimately about patient safety. It’s about understanding the genesis of the products you deliver to the market and how they are ultimately delivered to the market. And if something does go wrong, it’s about quickly identifying and correcting the problem, minimizing the impact on product availability, and preventing any adverse impact on the patient.
In addition to ensuring patient safety, a well-defined supply chain will reduce risk by ensuring upstream and downstream quality, aiding in your organization’s ongoing pursuit of regulatory compliance. This continuous performance also will be reflected in improved overall business metrics, such as reductions in supplier defects and supplier returns, improved in-compliance product ratios, reduced scrap and waste, and reduced re-work and improvements in first pass yield.
Reduce Supplier Risk, Reduce Organizational Risk
This e-book addresses ways to reduce supplier risk in your organizations, and the role of Quality in that process.