Product Lifecycle Management and Vendor Qualification

We conduct in-depth audits to assure that the vendor has the ability to maintain full compliance with current GxPs and satisfy any additional specific issues that may be defined in your Marketing Authorisation.

We offer services such as the evaluation, selection, auditing and monitoring of the appropriate GxPs for:

  • Excipient suppliers
  • API suppliers [EU GMP Part II]*
  • Packaging material suppliers [PS9000:2015]
  • Sterilisers
  • Contract Analytical Laboratories
  • Contract Manufacturing Organisations
  • Supply Chains
  • Storage and distribution centres.

We excel in helping to interrogate the overarching quality system in relation to lifecycle compliance and assist your Quality Departments to audit and coordinate operational activities in the following areas:

  • Developing vendor audit programme
  • API QP Declarations*
  • Quality and Technical Agreements
  • Quality Management Systems
  • Site Master Files
  • Change Management
  • Quality Risk Management
  • Complaints and Product Recall
  • Marketing authorisation compliance audits.

*As the European Regulatory Authorities have accepted the use of ‘third party audits’ then through the use of our services we can ensure you will comply with your obligations under Article 46(f) of Directive 2001/83/EC. We can provide a customised audit report detailing all of the information required by your company’s QP to facilitate a “Declaration of GMP Compliance” for your API suppliers and disposition of drug product, or provide the API QP Declaration on your behalf.

 

Quality validation activities

Our team can provide support in Facility Commissioning; Qualification, and Validation activities. Validation requirements are often complicated and confusing. Our experts can clarify these complex requirements and also ensure that companies are carrying out activities to the latest standards and only validate those systems and processes that are necessary and meaningful. We provide expert coverage for activities including:

  • Cleaning Validation
  • Process Validation
  • Computer systems and software validation
  • Equipment validation.
 

Compliance with the Falsified Medicines Directive

We can process map your supply chain to help you understand its complexity and ensure that action is taken to minimise any risks to your product as required under the Falsified Medicines Directive 2011/62/EU. Our services include:

  • Select, evaluate and define transportation routes and contingency plans.
  • Selection, evaluation, auditing and validation of transportation companies.
  • Selection, evaluation, auditing and validation of storage and distribution centres.
  • Develop or improve your Quality & Technical Agreements with your suppliers and third parties; defining respective GxP responsibilities; and supporting effective vendor management as required by EU GMP Chapter 7 Outsourced Activities.
  • Evaluation of API and Finished Dosage Form transportation from manufacturer to end users.
  • Marketing authorisation compliance audits.
 

Quality Training

Working with your quality department, our team can provide bespoke training in relation to the needs of your organisation. Our team specialises in helping to build continuous improvement programmes to build quality and compliance into the culture of an organisation.