Summer 2021 Update

This update reflects the current Covid situation in August 2021.

After a challenging 20 months life is adopting a new normal and the pharmaceutical industry is adapting to the new environment.

Regulatory inspections on site are recommencing and there is still an element of remote work too.

Similarly, MQA Solutions are now working with a number of clients both remotely and on site. GMP education, auditing, Quality system support, remediation work and Qualified Person availability is the focus for MQA assignments in both the pharmaceutical and allied personal care businesses.

As our business returns to a more normal way of working demand for our services continues and please contact us if we can support you.

Summer 2020 Update

Writing the MQA summer 2020 update reflects on a uniquely challenging 4 months of Covid-19.

As a provider of a range of pharmaceutical consultancy services including education, auditing and remediation activities, many of which are delivered on sites across the globe the pandemic immediately impacted on the planned progamme!….however

…the industry has adapted to use technology to support some of these requirements and along with the rest of the world…Zoom, MS teams and other platforms have been fully utilised to keep the business moving.

MQA has been able to contribute using technology and a range of courses have been presented  under the NSF education programme and remote auditing is also being supported.

MQA continues to work with a number of UK clients to support on site PQS activities in the marine and veterinary pharmaceutical sectors and as we move out of the lockdown restrictions there are early signs that the QP and PQS requests are starting to return..

Contact MQA if we can provide services to improve compliance and add value to your business.

Stay well, stay safe….

MQA Winter update 2019/2020

In 2019 MQA continued to work across a multitude of projects with an expanded client base.

In association with a number of customers, MQA supported several global GMP education, audit and remediation activities, both in finished product dosage forms and active pharmaceutical ingredients (APIs).

MQA supported Pharmig in the UK, Ireland, Sweden and Germany and was present at the PCP and Annual conferences. 2019 also saw MQA work in Veterinary medicines and there was an increased demand for services in auditing Personal care facilities.

Welcoming in the new decade and 2020. MQA welcomes back returning clients with requests for additional services and the first quarter of 2020 has commenced with EU GMP/FDA and Personal care support activities.

EU GMP Annex 1 update for sterile products is still awaited and MQA is prepared for the implementation of this long awaited update

Please contact MQA if your business requires assistance across a range of GMP/QP/Quality improvements. Contact details for MQA are on the website or via email directly and we will be happy to work with you in delivering tangible benefits and cost-effective solutions.

With best wishes for 2020

Tony

Winter update 2018/2019

Having experienced an amazing summer we are now saying goodbye to 2018 and welcoming the new year and opportunities in 2019.

Thank you to all those clients that MQA worked with during 2018. Numerous projects in the pharmaceutical industry were completed across the globe. Assignments included training, auditing and specific remediation work. Client feedback was very positive, and it was encouraging that clients had repeat requests for MQA services.

MQA also supported the Pharmig 2018 November conference and took the opportunity to add to the network of contacts and explore industry requirements now and into the future.

Elsewhere Brexit continues to influence decision making and has added additional workload. The Serialisation and FMD deadline also approaches and companies are making final preparations for implementation.

Annex 1 update for sterile products has yet to be announced and this is sure to add to the project plans in 2019.

MQA already enjoy a very busy January and several projects are in discussion for February and the 2019 is looking like another busy year.

Please contact MQA if your business requires assistance across a range of GMP/QP/Quality improvements. Contact details for MQA are on the website or via email directly and we will be happy to work with you in delivering tangible benefits and cost-effective solutions.

With best wishes for 2019

Tony

Summer Update 2018

As we approach mid 2018, MQA Solutions have been supporting a number of remediation and improvement requirements in North and South America as well as several European projects. The range of work has been both challenging and satisfying in assisting clients with value added quality and GMP projects.
MQA also participated in the Pharmig PCP conference in April and it was very positive to see the PCP format attract a range of attendees from both non sterile pharmaceutical and cosmetic companies. Shortly after the Pharmig event MQA also attended Making Pharmaceuticals in Coventry. This event was very well attended and always provides the opportunity to learn from the presentation sessions and network with clients and colleagues. As a free entry event it continues to be very popular.
MQA currently have a number of ongoing projects and 2018 continues to be a busy year. With no clear Brexit direction for the UK pharmaceutical business we see organisations having to make contingency plans and MQA has been supporting companies with these plans.
The deadline for Serialisation and the FMD directive draws nearer and this also is impacting Quality and GMP resources.
If your organisation requires assistance across a range of GMP/QP/Quality improvements please contact MQA through the website or via email directly and we will be happy to work you in delivering tangible benefits and cost effective solutions.
Have a great summer and make time to recharge over the holiday period…it promises to be a busy end to 2018.

2017 Review

In the review of 2017 the main change for MQA was the move at the end of the year to supporting existing and new customers through a full time consulting business. A number of customer audits were successfully delivered and there was increased presence at a number of professional and technical conferences and events.

Of note in 2017 was the annual MHRA GMP/GDP conference that highlighted a number of areas of concern for the regulators including theft and losses, transportation deficiencies and Responsible Person duties in GDP. In GMP, deficiencies in Supply chain compliance, failures in QMS performance and continued issues in data integrity are being seen during regulatory inspections.

Several changes to legislation requirements were introduced including for clinical trials and in addition 2017 saw the long awaited MRA for the EU and USA, updates to the introduction for Serialisation and Annex 1 for sterile products. Not surprisingly Brexit and possible implications for UK Pharmaceutical business continue to be a source of discussion and contingency planning.

In the coming year MQA will continue to deliver professional and technical solutions for clients and if we can assist your business please email us through the web site.

2016 Review

2016 has seen the significant update to Annex 16 of the EU GMP Guide and the roles and responsibility of the Qualified Person (QP). This continues to add to the importance of the QP in the assurance of safety, quality and efficacy of medicines. QPs and Regulators are working to the new requirements and please contact MQA if we can support your implementation.

In addition there has been continued focus by regulators on quality, GMP and data integrity compliance both inside and outside the EU. The importance of API GMP and GDP across pharmaceutical supply chains is another area of focus for QPs in all operations.

MQA have been active in auditing and training in 2016 in personal care operations and the application of ISO 22716. Please contact us if you require assistance for these audits.