How to Prepare for a GDP Audit - An Interview with Dr Nicola Spiggelkötter

You need to ensure that you are providing a quality product all year round, and being audit ready is a fundamental pharmaceutical principle. Dr Nicola Spiggelk÷tter from Knowledge Support has 25 years plus experience in the remit of temperature controlled logistics, in this interview she speaks Cold Chain IQ about the priorities for good distribution practice (GDP) compliance, establishing a standard operating procedure (SOP) for the management of GDP audits and essential preparation steps for a successful GDP audit.

Cold Chain IQ: How have the expectations of authorities changed in recent years?

When it comes to increased awareness concerning temperature I think it has really changed in the last five years. Temperature has come into focus, and not only cold chain, but also the end controlled room temperature is a key point. The presence of so many logistic service companies that are engaged and specialised in the handling of these materials has also increased awareness. Inspectors know they have an important field of activities they have to inspect, to ensure quality temperature controlled logistics.

Cold Chain IQ: What are the priorities for GDP compliance? The objective of good distribution practice as described in the GDP guidelines is to ensure the quality of distribution operations for pharmaceuticals, and strengthen the integrity of the supply chain.

My top priority would be risk analysers and a risk-based approach. We know from the introduction of the revised GDP regulations, that the risk-based approach is a basic and fundamental change that not only comprises the handling and analysis of process, but always a general understanding, and this is really a key point for me.

Second, I would say qualification of the premises of the storage facilities, and along with that in third place is the qualification of the vehicles and the trucks, including all the vehicle packages that you use for shipment. Transport validation is always a hard issue, and if you have already done some validation exercises you know how difficult it is really to follow good validation principles.

Finally, training and implementing a training plan around key compliance issues is key. Being audit ready is a fundamental pharmaceutical understanding. You need to ensure that you are providing a quality product all year round. Cold Chain IQ: Why do you think some companies still struggle to implement a proactive approach to compliance? Proactive is a good term, but behind this term I would say there is a lot of money involved, a lot of time involved and a lot of staff for the execution and the realisation of it. If you are ready to go for fully compliant GDP, you need the full commitment of all people involved in the process from the very beginning. From senior management to key personnel, but also from people working at the storage facilities handling the parcels and the drivers. This is a difficult process, and as you know processes really ask for time. Cold Chain IQ: What would be your tips for establishing a standard operating procedure (SOP) for the management of GDP audits?

I think quite simple: take as a starting point your SOP for self-audit, change it concerning the focus that you have in the audit, because the first inspection audit is a general audit with no special focus, then make a self-inspection with a focus with a clear focus of GDP and then that should be the starting point to go for GDP.

Cold Chain IQ: What steps should a company take for preparing for a successful GDP audit? It’s a difficult question, not knowing the company, their status and level of quality. I would begin with the post audit files, begin what you have learnt from previous audits, and the first audit files I would always term as learning phase. Learn from what you have seen and what you have been told and then make a top list, according the criticality of the issues that have been found, the findings, and your priorities. Respect a clear strong and stringent timeline and have a person in place that supervises this timeline.

Cold Chain IQ: What would be your Dos and Don’ts for the follow-up post audit? The don’ts, of course, are not respecting the timeline, not respecting the findings, and not working on the filing list. The dos are the other way round so to speak. Cold Chain IQ: What advice would you give to a company preparing for a GDP re-audit? You have an audit report from the previous GDP audit, take that and focus on the findings that have been listed there. Ask yourself if you have really worked on these findings, if there are no more left over then have your quality manager, act as an auditor and have a internal pre-audit within your company.

Cold Chain IQ: In your opinion, what makes a good inspector?

A good inspector gives everybody the feeling that they are working for a common goal. They are not working as enemies; therefore it is good to define before starting the audit, a common goal. A good inspector is also neutral; s/he does not make any emotional or personal comments about the people involved. They encourage, praise always is good for motivation. [inlinead]

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How to Prepare for a GDP Audit - An Interview with Dr Nicola Spiggelkötter

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