Quality Consulting & Pharmaceutical Manufacturing.
Ashley Quality Consultancy Ltd. established in October 2006 by Miriam Holohan MSc. provides results driven, expert advice and support to Human, Veterinary, and Bio-Technology Pharmaceutical Manufacturing, and Distribution client companies on a broad range of Quality, Regulatory Compliance and Technical issues.
Together, we will provide your company with the best support and advice, in a professional and collaborative way, to help you achieve your objectives in a GMP / GDP compliant manner.
We expertly focus on Pharmaceutical, Biotech, API, Medical Device and Advanced Therapy Medicinal Product (ATMP) manufacturing companies.
Having in excess of 20 years Quality Management and QP experience within this highly regulated industry in both multinational and privately owned indigenous Irish Company’s, Miriam and colleagues at Ashley Quality Consultancy (AQC) Galway Ireland, have extensive knowledge and understanding of the Regulatory and Quality needs of its clients in the areas of e.g. Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and Good Clinical Practice (GCP). We are committed to providing customized solutions to companies via consultancy, coaching staff, contract management for small and large scale projects to deliver client goals.
As a partner of choice to leading Academic Institutions, Pharmaceutical and Med Tech Organisations, our goal in AQC is to impart our experience and knowledge to assist clients in maintaining and developing their compliance to GMP and GDP, thereby ensuring the quality, safety and efficacy of medicines provided by them.
- Qualified Person (QP) batch release in accordance with EU requirements (article 51 of EC Directive 2001/83/EC and Article 55 of EC Directive 2001/82/EEC) on commercial and Investigational Medicinal Products (IMP) covering both sterile and non- sterile various dosage forms, including Liquids, Solid Dose (Tablets, Capsules, and Powders), Biotech Products and Advanced Therapeutic Medicinal Products.
- Proven track record in the project management of achieving facility certification to GMP/GDP by the HPRA for pharmaceutical manufacturing & distribution both in Ireland, Europe and the Middle East.
Quality, Regulatory & Validation Support
Examples of Quality /Regulatory Documents which we can prepare /review for you include:-
- Applications to Health Products Regulatory Authority (HPRA) for regulatory authorisations (e.g. MIA and WDL, ASR) and or variation applications.
- Site Master File, Quality Manual and QMS procedure development and review.
- Clinical Trial Applications - Review of regulatory submission documents e.g. Investigational Medicinal Product Dossier (IMPD), and Clinical Trial Protocols.
- Supply Chain Quality Management- Preparation of Quality/Technical Agreements covering various scenarios e.g. Contract Manufacturer, API , and Packaging Suppliers, Clinical trial stakeholder agreements and Service Level Agreements. –
- Validation / Qualification Protocols development and review.
- Pharmaceutical Wholesaling – Development and Implementation of quality management procedures and systems for product storage, distribution, and transportation. Provision of Responsible Person Services in accordance with Good Distribution Practice of Medicinal Products for Human Use 2013/C 343/01.
Ashley Quality Consultants provide a range of training programs to meet your needs. This includes standard training to satisfy regulatory requirements or we can provide tailored training to meet your specific needs. Training courses can be delivered at the client’s site or off site. All training is assessed upon completion and a training certificate is issued to each participant for inclusion in the individual's training file.
We provide the following training /coaching services:
- GMP Induction and annual retraining specific to Manufacturing, Distribution and support functions.
- Regulatory Inspection Preparation (including communication skills in an inspection).
- Technical Training e.g. Contamination Control – Microbiological Considerations.
- Quality System module training including Risk Management, Vendor Qualification, Change control, documentation, customer complaints.
- Client specific training as required.
- Provide certified Internal Auditor training (tailored to suit your facility) to enable your team to execute audits in compliance with the relevant standard e.g. GMP, GDP and or ISO.
Ashley Quality Consultants are trained lead auditors (IRCA) and have extensive experience in the requirements for both Pharmaceutical (including API, Solid dosage, Sterile and Biopharmaceutical, ATMP Manufacture) and Medical Device companies.
We will provide you with auditing support in the following areas:-
- Introduction of Internal and External Audit programs – SOP and Audit schedule in compliance with GMP, ISO Standards e.g. 9001:2015, ISO 13485.
- Initial qualification audits to approve new supplier and subsequent routine audits to satisfy your Vendor management requirements.
- API Supplier audits as per ICH Q7A and EU GMP Vol 4
- Third party manufacturer audits (Tablets /capsules /liquids including sterile products) in compliance with GMP.
- Sterilization subcontractor audits (Ethylene Oxide, Gamma and E Beam)
- Contract Laboratory audits – Biological, Microbiology and Analytical Chemistry.
- Warehouse and Transport company audits.
- Due Diligence audits.
- Simulated Inspections in preparation for Regulatory Inspections – HPRA, and various Notified Bodies – NSAI.
- Audit Closure and compliance monitoring thereby ensuring that non-conformances and CAPA’s are appropriately addressed.