"Do you know where your raw material really comes from?" This is a question I have asked again and again to companies I have been consulting. In most of the cases the answer is YES. And in most of the cases this is not necessarily true.
A lot of companies would purchase only from a validated and approved supplier. Usually the supplier validation is based on a questionnaire sent to the supplier by a dedicated supplier validation entity, by QA or by purchasing. Over the years I have seen a lot of these questionnaires. They are very much focused on product quality, raw materials traceability, cross-contamination, risk reduction, company turnover, structure, disaster recovery / business continuity plan, internal trainings, documentation, certifications. Very rarely I have seen someone asking:
Is this product manufactured by YOU in YOUR own facility and with the participation of YOUR own staff?
The assumption that a company, shipping products under its own label and being able to answer the standard supplier qualification questions is a manufacturer, is wrong. However most companies must rely on the information they have or have been given, mainly for two reasons:
- the supplier database is "historically generated". Many entries are dated several years back - when supplier questionnaires and validation systems were not even existing. Out of convenience or for various internal reasons the existing database is rarely or never thoroughly reviewed
- very few companies have sufficient resources to visit their suppliers and personally inspect the site and manufacturing process of their raw materials. They limit their supplier validation to a paper audit or to a site inspection only for a small number of key products. A new product added to the portfolio of an existing audited supplier may simply be considered manufactured in their facility
As a result of this practice a large number of retailers selling under their own label are considered manufacturers of raw materials used in the biotechnology sector.
Indeed it is a comforting thought that there is a large number of manufacturers out there and one can make a choice between different suppliers. The question is how safe this assumption is:
· The less we know about the real manufacturers of our raw materials the harder it gets to recognize changes on the market or upcoming shortages.
· Product knowledge gets lost with an increasing length of the supply chain.
· Important change notifications may or may not reach the end user.
· Products may suddenly become unavailable because the supplier (erroneously considered manufacturer) has decided to stop dealing with a specific raw material. In this case there is no backup plan. Worst case scenario - the discontinued catalog number has been included into a product registration file of the end user.
At present the pharmaceutical industry is dealing best with this kind of issues. Often driven by regulatory requirements many - mainly bigger - manufacturers of pharmaceutical products thoroughly check the origins of their raw materials. For the rest of the end users the line between supplier and manufacturer remains blurred.
It is not possible to go everywhere, visit everyone and check every detail when higher priorities require attention and when resources are limited. It is possible however to make sure this is done - the possibility to outsource the approval and validation process is given. At M bioserviceS we visit all our manufacturing partners before starting a cooperation, perform an audit and prepare a validation file. Only after a successful completion we can recommend a manufacturing partner to an end user. We do that extra travel and make that extra check saving our customers' time and resources.
Because we believe that origins matter.
If you believe that too let's have a conversation.
