Sometimes even the best run pharmaceutical company needs a little helping hand to ensure that their quality systems are in tip top condition and that everything is squared away.

Chiesi

Earlier this year we had the pleasure of working for Chiesi UK, a mid-sized pharmaceutical company confident in its systems but committed to ensuring all of the boxes were ticked, ahead of their scheduled inspection by the MHRA.

Knowing our commitment to the highest standards and our practical, hands on involvement, Chiesi approached us to provide them with interim QA support over a 3 month period to ensure everything was as ship-shape as possible before their inspection date.

 

Scope

The list of activities that we were involved in was long and exciting for those of us who, deep down can’t get enough of an SOP or a PQR. From updating policies, delivering training, reviewing approved suppliers to arranging and conducting audits, our team worked alongside the client to carry out a complete review and update of those parts of the Pharmaceutical Quality System that needed the most attention.

 

The Result

The best part? We were all really pleased when the client passed their MHRA inspection with flying colours!

 

The Added Advantage

At Quality Context we don’t charge for time we haven’t spent. It transpired we were more effective and efficient than even we expected. Everything was done well within budget, meaning that when we said “adieu” to the client they not only had everything that they needed but also some spare money to invest elsewhere in growing their business.

 

Testimonial

We are delighted with the feedback that we received. Mr David Barnes, Technical Director and QP at Chiesi, had this to say about our service:

“With an impending MHRA inspection, an office relocation one month prior to the inspection, an unplanned change in the senior management of the Technical Department and a new QA team, Quality Context were there to give Chiesi the support they needed to help them on their complicated and unplanned journey.

Kate and her team were fantastic in providing the full support package, tailored to our exact needs, whether it be liaising with our suppliers to arrange audits, compiling APQRs, performing GMP training, SOP writing, or simply being there at the end of the phone for adhoc advice or some simple, friendly, moral support. The relationships forged during the relatively short period of time will continue to grow stronger as the two companies will undoubtedly continue to work together over the next few years.”

 

Further information

If you are looking to prepare for an inspection or simply want to ensure your quality systems are in tip-top condition then:

Call: 0114 252 1189

Email: enquiries@qualitycontext.com