Compliance & Quality

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    We can provide a flexible and efficient solution to any of your Quality problems.

    Our aim is to ensure that any proposed solutions to your quality problems meet with the required levels of Regulatory compliance in a cost effective and not cost prohibitive manner.

    For any of these or any other aspects of quality services, contact us 01279 441 616

    Product Life Cycle Management

    Diamond Compliance and Quality can deliver services across the whole product lifecycle.

    ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

    For the purposes of this guideline, the product lifecycle includes the following technical activities for new and existing products:

    • Pharmaceutical Development:
    • Drug substance development;
    • Formulation development (including container/closure system);
    • Manufacture of investigational products;
    • Delivery system development (where relevant);
    • Manufacturing process development and scale-up;
    • Analytical method development.
    • Technology Transfer:
      • New product transfers during Development through Manufacturing;
      • Transfers within or between manufacturing and testing sites for marketed products.
    • Commercial Manufacturing:
      • Acquisition and control of materials;
      • Provision of facilities, utilities, and equipment;
      • Production (including packaging and labelling);
      • Quality control and assurance;
      • Release;
      • Storage;
      • Distribution (excluding wholesaler activities).
    • Product Discontinuation:
    • Retention of documentation;
    • Sample retention;
    • Continued product assessment and reporting.

    Diamond Compliance and Quality provides an advice and support service in relation to GxP requirements across the product lifecycle, from pharmaceutical product development to market and beyond for all pharmaceutical product types.

    Regulatory Inspection Preparation

    Do you have?

    • A new facility undergoing construction and are preparing for your first inspection by an EU regulatory authority or agency such as the USFDA?
    • A recently completed qualification of new or improved processes, or have you introduced a new system and want to know if it would meet the expectations of the inspector in terms of regulatory compliance?
    • A GxP re-inspection scheduled?

    Then Diamond Compliance and Quality can assist by undertaking a pre-approval inspection or mock inspection and gap analysis prior to the inspection by the regulatory agency. Our team of auditors have experience of over 50 regulatory inspections undertaken by various agencies including the MHRA, IMB, EMA, SUKL Czech Republic, USFDA, MCC South Africa and Anvisa Brazil, in England, Ireland, Czech Republic, Argentina and India.

    We offer services such as:

    • Conducting pre-approval regulatory inspections in all areas of GxP.
    • Conducting mock regulatory inspections in all areas of GxP.
    • Provide guidance on corrective actions to be implemented and validated prior to the regulatory inspection. This will give you the opportunity to rectify any issues prior to them being cited as regulatory non-compliances by the inspector.
    • Provide training on how to prepare for a successful regulatory inspection, including mock inspection interviews, and the ‘Do’s and Don’ts’ of hosting and interacting with regulatory agencies.
    • Inspection readiness reviews – especially important now that unannounced inspections are becoming more frequent.
    • Reviewing level of compliance with best practice standards with a view to applying for, renewal or retention of the necessary appropriate licences, such as MIA, WDA, MA, GMP and GDP.

    Vendor Management

    One of the key drivers within the pharmaceutical industry is cost reduction as demanded by those who pay for the end product, whether this be the patient, insurance companies or a government.

    This cost containment drive has resulted in global rationalisation of manufacturing to sites with the resultant complexity of sourcing and managing vendors and third parties involved within the supply chain, to the extent that regulatory inspectors are targeting supply chain validation and compliance.

    Any changes to the registered manufacturing and testing sites, or addition of alternative API‘s within the marketing authorisation requires the processes to be transferred, validated and stability data generated prior to submitting a variation.

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

    We offer services such as:

    *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 underArticle 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.

    Wherever possible, confidentiality permitting, we would also consider the possibility for sharing audit reports so as to keep costs to a minimum.

    Supply Chain Compliance

    The drive for cost containment within the pharmaceutical industry has resulted in the global rationalisation of manufacturing sites. With the resultant complexity of sourcing and managing vendors and third parties involved within the supply chain, validation and compliance is a prerequisite for regulatory agencies.

    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.

    We can offer services such as:

    Qualified /Responsible Person Services

    We are able to offer a range of Qualified Person and Responsible Person services to your business.

    We can offer services such as:

    • Provision of contract QP services in compliance with EU Directives for the manufacture and release of finished pharmaceuticals and GMP.
    • QP services for the batch release of IMPs for clinical trial.
    • Provision of contract RP services in compliance with EU Directives for the wholesaling of medicinal products and GDP.
    • RP services for quality defects and product recalls of your Marketing Authorisation (MA) applications.

    Computer System Audits

    We provide guidance on how computer systems should be validated to meet cGMP requirements and/or provide highly independent audits to assure your computer software vendors also meet the requirements to ensure a GMP validated system

    General cGMP Compliance Audits

    We provide cGMP Compliance Audits to you on a one time or annual basis.We conduct highly independent and impartial audits and provide reports to you with suggestions for improvement.

    Quality Systems Review

    Compliance to GMP can only happen if there is a strong and well defined Quality System.Unfortunately with the ever changing legislative requirements, it is not always easy to maintain a Quality System that meets the current requirement.

    Through the use of our services we can ensure that your Quality Systems not only meet current requirements, but are prepared for any new requirements that are currently going through the Regulatory consultation process.

    Quality Validation activities

    • Facility Commissioning; Qualification, Validation
    • Cleaning Validation
    • Process Validation
    • Computer systems and software validation
    • Equipment validation

    Validation requirements are often complicated and confusing.Our experts can help remove this fog and also ensure that companies are:

      • Carrying out validation activities to the current standards
      • Only validate systems and processes etc. that actually require formal validation.

    Product Development and Regulatory Compliance

    Development projects not to schedule?

    Then use our ability to solve technical problems with creative practical solutions that will bring your projects back on time.

    Sometimes a fresh approach can provide solutions that have failed to be identified, simply by being too close to the subject.

    All aspects of Quality Training

    The performance of any company relies on the commitment, contribution and enthusiasm of its employees.In this highly competitive industry being able to unlock the potential of individuals and teams is essential to a company’s success.

    So, in the ever changing world of the supply of medicinal products, we can provide tailored focused training to motivate and improve staff performance which is critical to a company’s success and also meets the professional development requirements of individuals.

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