How to audit a Freeze Dryer Supplier

How to audit a Freeze Dryer Supplier

July 22, 2019

In the last 25 years, the percentage of freeze-dried products has increased from 10% to almost 30% of the existing parenteral drugs. In addition, 80% of the freeze-dried parenteral drugs are lyophilized in vials. Vials are the most standardized solution for freeze drying products, such as vaccines, peptides and proteins, due to the enormous advantages for transport and shelf life.

 

The continuous development of new formulations and products of the pharmaceutical industry requires freeze dryer suppliers for constant delivery of solutions to comply with current regulations, the growing market demand and productivity.

 

BUT, how can we select the best freeze dryer supplier for our freeze-drying line?

 

LyophilizationWorld is glad to provide a small guide with major concerns around this selection and especially follow up of worldwide freeze dryer suppliers.

 

Freeze dryer supplier GMP consideration

In EU GMP on the Personnel Chapter, it states that the Head of Production and Quality Control are responsible for the approval of suppliers as a shared duty and in Chapter 5 (the Production Chapter), there are some additional requirements concerning starting materials. GMP states that “starting materials should only be purchased from approved suppliers” and this must apply to freeze dryer suppliers as well.  

 

ISO 9001 applied to freeze dryer supplier

Apart from the GMP the ISO 9001 (international standard for Quality Management Systems), also has some good ideas when it comes to freeze dryer suppliers. The message of ISO, in a nutshell is that the controls imposed on a supplier can vary based on impact to product quality. In a pharmaceutical context then it is therefore likely that you will audit a freeze dryer supplier while you will not for a sterilization equipment.

 

Freeze dryer supplier Approval process

In our experience, the following steps are the baseline for a successful freeze dryer purchase:

 

Stage 1 – Evaluate potential options. In this stage freeze dryer suppliers that may be able to supply you are looked into. High level information on each supplier must be obtained to establish if they may be able to meet your needs (from equipment perspective, timing, quality etc.). It might be helpful for new users (first freeze-dryer or freeze-drying line) to hire a consulting service or ask the help of other well-established lines.

 

Stage 2 – Gather deeper level of information. The short-listed freeze dryer suppliers may be sent initial URS to gain further information on the organization. In addition, a visit to the equipment manufacturer can be a useful measure to study factory size (and so experience and/or availability) among other factors.

 

Stage 3 – Audit. The auditor should be suitably trained and competent, with external specialists taken as part of a team if necessary.

 

Stage 4 – Negotiation. During this step the support from experts (in case it is a first line containing a freeze-dryer) is mandatory. Negotiation in this phase include, not only the economical side but also aspects related to the freeze-dryer itself, associated equipment, layout configurations etc.

 

Stage 5 – Aapproval. If you are satisfied with the equipment so far, they may me moved to full approval status.

At any time, a freeze dryer supplier can be moved back and not be the primary choice for future projects or even rejected as a supplier if you have any concerns.

 

On-going monitoring of freeze dryer supplier

Don’t forget that after a supplier has been approved then their on-going performance still needs to be monitored. This should also feature in annual Product Quality Review reports.

On-going monitoring is a team effort and should consider both GMP and non-GMP/ business related issues:

 

Purchasing and management: freeze dryer supplier

Once you have approved a freeze dryer supplier you are likely to start purchasing equipment from them. EU GMP has a very brief mention of purchasing in Chapter 5. There is a very important point within this requirement as individuals involved in purchasing must have an appreciation of the impact of supplier’s material with the quality of the finished medicinal product. Furthermore, selecting suppliers based on cost alone may not either be cost effective or meet GMP requirements.

 

What is important to highlight is that purchasing is often performed by Logistics, Financial or Purchasing Departments that have no background (in most cases) about the equipment itself and the final products produced in it; so, the task of freeze dryer supplier selection must be an effort team involving several heads and/or external support. At LyophilizationWorld we are proud to say that our work in consulting, URS preparation and freeze dryer supplier audits have helped many pharmaceutical companies worldwide.

 

 

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