A&M Pharma Services, Andrew White and Mark Burgin are both experienced consultants within the pharmaceutical industry and have 40 years combined service within the industry. Established in 2021, A&M is a privately-owned consultancy who’s role is to provide a full range of QA services to the pharmaceutical industries globally.Mark is a certified IRCA Lead Auditor, ISO 9001 lead auditor and registered RP/RPi who is a highly motivated and ambitious individual with a wide exposure in quality assurance and control as well as compliance and regulatory knowledge in the pharmaceutical, medical device and food industry. Expertise in pharmaceutical quality systems, non-conformance and CAPA management, auditing and continuous improvement. Andrew is a registered RP and Certified IRCA Lead Auditor and possesses 25 years’ experience within the pharmaceutical and healthcare industry across a wide variety of dosage forms and complex supply chains. His speciality is API, tablets, liquids, and sterile dosage forms and has conducted in excess of 150 audits. Andrew has excellent working knowledge of current FDA, MHRA and ISO regulations and is eligible to act as Responsible Person.ServicesAudit ServicesBoth Mark and Andrew are IRCA qualified lead auditors and have a wide range of experience in all areas of GMP, GDP and API audits. They are not only qualified but are field experts who are willing to travel globally to audit your suppliers and regularly keep up to date with the ever-changing regulatory standards. PQS ServicesWe are experienced QA professionals with a proven track record who can provide a wide range of support to our clients. Contract RP/RPi ServicesWe specialise in preparation for regulatory inspections and customer audits. We have Contract Responsible Persons and Responsible Persons for Import available who take ownership for the application of Good Distribution Practice on site and will ensure that all licensable activities you undertake remain compliant.

Provision of consultancy in Quality Management systems to the Pharmaceutical and Medical device industry.

Provision of technical expertise in the creation and update of over 50 quality technical agreements for in licensed and out licensed medicinal products, primary and secondary packing materials and GxP relevant service providers. Creation of an approved supplier list based on risk rankings to prioritise current and future vendor assurance activities.

Provision of interim Quality Systems management

Responsible for the Quality Compliance of a wide range of both Food and Pharmaceutical Health Supplements for the leading brand Seven seas and many Retailer Own label products. Responsibility for the vendor assurance programme and supporting the technical transfer of products to CMOs

Supporting Viaflo production with Quality System commitments, change controls and audits. Responsible for production documentation associated with deviation, CAPA and complaint management. Creation and execution of various validation protocols as part of the continuous improvement of the Viaflo process.

Main responsibilities include batch review and release of product; deviation, CAPA, change control and complaint management; review and approval of SOPs, both QA and production protocols for validation, cleaning and master manufacturing procedures. Provision of advice and support for quality related issues that occur not only within the production environment but also within the wider QA/QC team. Globally certified deviation and complaint investigation and approval expert. Site certified rapid Root Cause Investigation expert

Providing GMP expertise and oversight in the areas of microbiological systems, facilities and cleaning validation; including review and approval of GMP relevant SOPs, deviations, quality reports, and cleaning validations; ensuring current regulatory guidelines are assessed and implemented as necessary and in required time frames; and the involvement in health authority, regulatory and internal audits.

South and East Midlands Area Technical Account Manager for the second largest pre-prepared culture media supplier in the UK. This role involved meeting and liaising with current and potential clients in the NHS, pharmaceutical, food and industrial sectors with regard to their current and future media requirements

Employed as a site microbiologist with responsibility for co-ordinating all aspects of QC microbiology testing and as the technical contact for all microbiological issues. As my role progressed I become a GMP specialist with responsibility for managing and directing all quality control and quality assurance activities, pertaining to all microbiological services and projects required for the efficient running of the site