contract qps

7/29/2019 Contract QPs

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Crown copyright 2008

Safeguarding public health

CONTRACT QPs:

HOW MUCH IS TOO MUCH?

Richard Funnell,Senior GMP Inspector,Liverpool, 11 November 2008


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Slide 2

11 November 2008Richard FunnellContract QPs: How much is too much?



Introduction

An individual must be eligibleto be a QP.

To appear on an MIA or MIA(IMP) the individual must also be deemed

suitableby the MHRA inspectorate.

- Sufficient relevant experience.

- Readily available.

- (MHRA policy the QP should be resident in the UK).

Please submit eligibility certificate and CV with the application/variation.

If not deemed suitable the application/variation will be refused. Contract QPs are exactly the same.


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Slide 3




What is a contract QP?

Explained in the QP Codes of Practice (see Orange Guide).

Duties and responsibilities are exactly the same.

Some extra requirements (e.g. clear written contract).

- This is likely to be a key area of interest during an inspection.

Familiarisation with the company and its systems is more of an issue. Being readily available is more of an issue.


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Slide 4




Upon receipt of an application the MHRA will:

Check for QP eligibility.

Check for relevant experience.

Check for the chance to become familiar with quality systems.

If a contract QP check for availability.

- System search to see what other licences (if any) the new QP isnamed on as a QP or RP.

- Ask the new QP for more information or an explanation.

- Copy letter to submitting organisation. Refuse the application/variation if not satisfied.


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Slide 5




So. How much is too much?

Impossible to be definitive.

Will alwaysdepend on QPs professionalism and experience.

Verybroad guidance.

1-2 4-7 9-12 >12

OK More info required Serious concerns !!!!


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Slide 6




Questions to ask yourself:

Do I really have enough suitable experience?

How will I familiarise myself with the quality system prior to certifying

batches? Can I really take this extra contract on?

- It is not just the time taken to certify batches.

Who looks after things when I am not there?

How will I communicate with any other QPs?

Have I been removed from previous licences?

Will I be able to support regulatory inspections?

Can I defend my position in writing if requested?


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Slide 7




Some tasks other than batch certification:

Maintaining familiarity with the productionprocesses.

Being aware of contents of MAs.

Reviewing PQRs.

Making decisions on recalls.

Gaining awareness of all relevantcustomer complaints.

Having a broad knowledge of analytical

methods. Participating in deviation investigations.

Reviewing trending outputs.

Keeping up to date with environmental

monitoring.

Reviewing tech agreements.

Participating in capital projects.

Continuous Professional Development

Giving training to staff. Conducting self inspections.

Providing input into controlled changes.

Assisting with review of SOPs.

Approving master manufacturing records.

Performing audits of other companies (UKand overseas).

Knowing about calibration and maintenance

schedules.

Ensuring appropriate retained samples arebeing kept.

Participating in regulatory inspections.

Conducting OOS investigations.

Knowing validation status of equipment andprocesses.


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Slide 8




Closing points:

MHRA must be satisfied as to suitability of individual.

It will alwaysdepend on the QPs professionalism.

Have you been removed from previous licences where you are nolonger active?

If MHRA not satisfied, the application/variation will be refused.


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Slide 9





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Good Manufacturing Practice(GMP) Symposium

Best practice guidance for

Qualified Persons

11 November 2008

Medicines and Healthcare products Regulatory Agency

contract qps

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