Qualified Person & Responsible Person

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Services

  • Qualified Person services as per Directive 2001/83EC
     

  • Quality improvement programmes based on Kaizen and tailored to company requirement
     

  • Quality Systems implementation and compliance programmes

    • Pharmaceutical Quality Systems (ICHQ10 basis)

    • ISO2001:2016
       

  • Act as Responsible Person as per GDP requirements (2013C/ 343/01) and RP-I from Jan. 2021.
     

  • Provision of MIA & WDA licences in conjunction with trusted partner organisation.  CommQP can also assist in setting up these authorisations e.g. QMS, labs etc.

  • Mukesh started his pharmaceutical career at Mars Inc. (veterinary medicines business unit) and he was instrumental in the set up of the company Manufacturer's Imports Authorisation (MIA) and Marketing Authorisations (MAs) in association with veterinary licence holding partner companies. 
    He successfully obtained marketing authorisations for a novel class of veterinary medicinal products which were unique and the first such licensed products in the UK. 

Background 

  • CommQP Qualified Person’s can certify various dosage forms which include tablets, capsules, liquids, sterile products, ionising radiation products and veterinary products.  QP & RP services are core activities conducted since 2006.  
     

  • CommQP have three eligible QPs (all permanent provision) and one Trainee QP.  

Case studies
 

  • Client problem:
    In 2017, one client had an adverse regulatory inspection approached CommQP to devise a remediation programme. 

    CommQP solution:
    Working with the WDA holder company, core issues were identified starting with interviews and a gap analysis audit.  Based on this information, the quality system was re-designed and supported with a bespoke training programme.
    On subsequent inspection from the MHRA, the WDA licence for the site was re-instated.
     

  • Client problem:
    An existing Indian client in 2016 required the set up of a WDA(H).

    CommQP solution:
    CommQP was involved in designing a QMS, providing training in GDP, being nominated as Responsible Person and hosting a successful MHRA inspection whereby WDA was granted.
     

  • Client Problem:

In 2019, CommQP were approached by a veterinary medicines client intending to establish a ManA.

CommQP solution:
CommQP provided the level of support required by the client as per their timeframe.  Activities ranged from planning and designing a suitable GMP facility, designing a quality system with required SOPs to providing bespoke training. 
In addition, the company were made aware of funding available for manufacturing companies and this yielded additional unexpected savings of ca. £45k.
This type type of activity has been conducted for two other companies in 2018 & 2019 though for human medicines.
 

  • Client problem:

In late 2019, a WDA holder company was required to attain a MIA for new forthcoming activities.  This was a time critical project.

CommQP solution:
CommQP assisted the highly responsive client and jointly co-developed a QMS and provided the required training for the newly assigned employees.  
The company passed the MHRA inspection and this activity from initial requirement to attaining MIA was < 3 months!

  • Client problem:
    In 2015, one major long standing client required QP oversight of a CMO, who had ongoing regulatory issues.

    CommQP solution:
    CommQP provided the required QP cover, often weekends and out of hours, in order to ensure continuity of supply of the required medicine.  Whilst on this site, CommQP assisted in driving a quality improvement programme instigated by the client's USA team.

     

  • Client problem:
    In 2015, one major long standing client required QP oversight of a CMO, who had ongoing regulatory issues.

    CommQP solution:
    CommQP provided the required QP cover, often weekends and out of hours, in order to ensure continuity of supply of the required medicine.  Whilst on this site, CommQP assisted in driving a quality improvement programme instigated by the client's USA team.

     

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