www.gmpcom.com

We are GMP ComplianceConsultants to the pharmaceutical and food supplements industry.

Your trusted quality & compliance solution provider.

Meet the key players...

We are a team of highly skilled and passionate individuals who together offer a valuable support and consultancy service to the pharmaceutical and food supplement industry. We truly love what we do.And it shows. We get it right in an industry where getting it wrong is not an option. Our clients feel secure in the knowledge that we have the right experience, qualifications and drive to deliver the right results.

Our team is everything and we are constantly improving and growing. Although we exist in a world of process and procedure we strongly believe that people are our most important resource.

Even as the company is expanding rapidly, the atmosphere is fun and exciting. No day in the office is the same. Every day is a new learning experience where we learn from and teach each other. Every single employee is willing to help and extend their expertise for the betterment of team and the end result.

Rachael DaviesQuality and Compliance Manager

Rachael has 12 years of experience within QC management, quality systems management and vendor assurance within the pharmaceutical, medical device and food supplements industries.

Karen OllettTechnical Manager

Karen has over 27 years’ experience in the pharmaceutical and food supplement industry. She has held various management positions within procurement, supply chain and artwork management.

Mark BurginTechnical Manager

Mark has over 11 years experience in the pharmaceutical, medical device and food supplement industries. His roles include microbiology management and GMP oversight. Mark is Lean Six Sigma trained and has an in-depth knowledge of root cause investigation, deviations and CAPA management.

Graham GleddenTechnical Leader

Graham is a professional electrical /mechanical engineer with 36 years’ experience working across various industries including marine, heavy industry, food and pharmaceutical.

Jenny JohnProject Leader

A passionate professional with 5 years of experience in project management, business administration, project coordination and quality management systems.

Giby GeorgeSenior Consultant and Managing Director

A passionate professional who truly cares for his team and clients. Giby has over 20 Years’ experience in the Pharmaceutical and Food Supplement industries. He has held senior management and technical positions in QA, Manufacturing, Quality Control, R&D, marketing and business development in the UK and overseas.

He is qualified to act as a ‘Qualified Person’ within the EU under permanent provision.

A little bit about us

A little bit about what we doOur knowledge and experience shows in our list of services - it’s extensive. But you can feel confident that we have every area covered...

We have extensive experience. We can streamline your processes and help to prevent problems occurring and deliver brilliant results.

Pharmaceutical Project ManagementIf you are making big changes in your business and need first class input and support, we can help with any and every aspect:

• Expanding your business

• Closing/decommissioning a site

• Introducing a new formulation or new/different manufacturing capability

• Creating a virtual operation

• Importing API’s & license products

• Reconstructing your business

• In need of formulation and quality & compliance remediation

• Introducing clinical trial projects

Technology TransferTechnology transfer is a process that spans the key phases of pharmaceutical development right through to commercial manufacturing including:

• Product transfers including API and drug product manufacture

• Processing, packaging and cleaning operations

• Quality control – analytical method transfer

We offer a complete solution for Technology Transfer (TT). Our dynamic and experienced technical, QC and QA teams have the ability to manage all your TT requirements without an increase in headcount. We can provide TT services in an optimum time scale with rigorous efficiency.

• Technology Transfer

• Validation

• Pharmaceutical Project Management

• QP services

• PQS

• Auditing

• Quality Investigation

• Regulatory activities

• Training

ValidationGMP Compliance has substantial experience in specialised contract validation services including facility, process and product validation and revalidation.

We can manage all your validation requirements from project management to report writing. Our experienced validation engineers can be based in your facility to execute validation testing and work with you to streamline the testing to increase efficiency and optimise testing value.

• Equipment validation

• Process validation

• Validation protocol development/report/field execution

• Product validation

• QC/microbiology method validation

• Cleaning validation

• Revalidation

We are focused on ensuring that our clients’ products and services meet or exceed the expectations of their customers

A little bit more about what we do

QP servicesWe provide a range of QP services and consultancy support to the pharmaceutical industry. Our Team has a strong knowledge and skills base in these areas and we make a great partner for companies who outsource for this kind of support

• Contract QP cover

• QP training, mentoring and due diligence

• Product release

• API QP audits and certifications

• CMO audits

• Management of regulatory inspections

• Quality system review and implementation

• Risk management

• Supplier assessment review and management

Auditing Our auditing process encompasses unique tools and techniques based on best practice guidelines and detailed background research.

We ensure that our auditors have the ability from a commercial, technical and GMP point of view to identify genuine risk and potential risk. We have hands-on experience in Global Supply Chain from a wide range of regulatory authorities. GMP Compliance can offer guidance and practical support in the following areas:

• Site audits and qualification of API manufacturers in compliance to ICH Q7, excipient manufacturers, contract manufacturers and suppliers, packaging and labelling contractors, warehouse contractors and contract laboratories.

• Site audits of finished products

• Pre-inspection approval assessments

• Auditing facilities to ensure an appropriate level of due diligence

• Pre-regulatory assessment audits and gap analysis

• Mock regulatory audits

• CMO fact finding inspections and investigative inspections

Our third-party audits meet the highest standards in quality and independence.

Pharmaceutical Quality System (PQS)The GMP Compliance team can provide experienced QA Specialists performing quality assurance services tailored to your needs at low costs in a time-efficient manner.

At GMP Compliance, we are focused on ensuring that our clients’ products and services meet or exceed the expectations of their customers. We plan and execute a coordinated set of activities that direct and control quality processes, whilst maintaining delivery schedules and price of our services. This requires improving systems, processes and resources that deliver and support your products and services.

Our services include:1. Generation, Implementation and improvement of PQS• Deviation/OOS• Change control• Risk assessment• Customer complaints management

2. Project management• Project design and implementation• GMP project assessment• GAP analysis• Change management

3. Regulatory compliance support• MHRA, FDA, EMEA and other regulatory body

inspection preparation• Audit management• GAP assessment• CAPA management• Risk mitigation support• Training

4. On-site resource for backlog management• Risk mitigation• CAPA management• Change control management

5. Interim quality management support• Design and implementation of PQS• Vendor assurance• CAPA Management

The training is based on hands on experience of where things have gone wrong and the root cause behind it. We also make you think about how to plan, design and implement projects with sound microbiological understanding. Learn the bugs before you get bugged!

A little bit more about what we do

Quality InvestigationsWe offer an independent open-minded and experienced resource to come and support your team in facilitating detailed root cause assessment and CAPA implementation plans. We recognise the importance of a structured approach to conducting root cause investigations and can provide guidance and support in this critical area.

• Generation and improvement of QMS

• Implementation of pharmaceutical QMS

• Redesign of QMS to incorporate major changes and changing business needs

• QMS for virtual operations

TrainingWe can create and provide a wide range of training for your needs. Our training packages are custom made to ensure you get the desired benefit. It is very interactive to ensure that the trainees achieve the desired levels of understanding. We can provide CPD and topic specific training on the following;

• GMP training

• QM training

• CPD training

• Microbiology and contamination management

• Continuous improvement and Lean Six Sigma

• Pharmaceutical water systems

The training is based on hands on experience of where things have gone wrong and the root cause behind it. We also make you think about how to plan, design and implement projects with sound microbiological understanding. Learn the bugs before you get bugged!

Regulatory activitiesOur regulatory team is from both the pharmaceutical industry and food supplement industry covering both UK/EU and international registrations.

• Regulatory submissions for marketing and quality certification

• EMA/FDA etc product compliance

• Provision of scientific data for regulatory applications and submissions

• Submissions for new product licences and licence variations and renewals

• Preparation of accessible product labels, patient information leaflets and storage specifications

• Planning and development of product trials and interpretation of trial data

• Advice for scientists and manufacturers on regulatory requirements throughout the development of a new product

• Management of regulatory inspections

And finally...

We will conduct every aspect of our business with honesty, integrity and openness, respecting the interests and needs of our employees and customers.

Our knowledge and experienceTo ensure that we have great knowledge and experience across all the areas in which we operate, we have chosen our team carefully and we are proud to have over 350 years of combined experience in the following areas within our company.

• Combined QA management experience of over 70 years across a number of different industries

• Combined experience of over 40 years in validation, electrical and mechanical engineering

• Technology transfer expertise for product portfolios to a multitude of CMOs

• Expertise in microbiological risk management and gap analysis

• Over 10 years’ experience in QC and micro QC management across a range of dosage forms and sectors

• Expertise in analytical and microbiological method validation in line with ICH guidelines

• Over 10 years of QP experience on active licences across a wide product range

• Generation of vendor assurance programmes and risk management of global supply chains

• Trained and competent auditors covering all supply services

The GMP Compliance team is made up of highly skilled and passionate professionals with a broad and varied range of experience.

Our key to each successful project is the team work that prevails throughout the company. Each team member is always willing to help and people are actively encouraged to share their ideas and experiences.

We strongly believe in continuous development and keeping our team members up to date, competent and well trained thereby ensuring that our clients receive top quality services.

Core Values

We care We don’t just want your business - we want to be a part of your business - because we care passionately about the results we deliver. Mediocraty is not an option on any level.

We work as a teamWe are a strong and cohesive team and when we work with you we hope to become an integral part of your team. We respect our colleagues, our customers and the environment. Teamwork is vital to what we do.

We have the relevant knowledgeWe operate in a highly regulated industry where mistakes cost money and potentially lives. We take knowledge, training and experience seriously - we have all of the relevent skills to make sure mistakes don’t happen.

We take ownershipYou will never see us walk away from a project until it is completed to your satisfaction. We have high standards and we stick to them, always.

• We work as a team taking ownership and accountability for the outcomes of all our actions in providing the best fit solution for you.

• Every service and solution that we provide for you, we try to ensure that they exceed your expectation.

• As a team we are more than happy to do whatever it takes to fulfil your vision and objectives as they are our commitment.

We are positiveLike most people we like to feel happy and enjoy our work. We have a positive mindset and attitude and like to smile - even in the face of adversity! We like clients to enjoy working with us - it’s important.

Our Services

Get in touch

T: +44 (0) 1482 797 171

M: +44 (0) 7549 613 010

E: info@gmpcom.com

W: www.gmpcom.com

HEAD OFFICE (ADMINISTRATIVE OFFICE)

Compass House,

17-19 Empringham Street,

Hull HU9 1RP, UK

OPERATIONAL OFFICE

1301 Hedon Road, Hull HU9 5NJ, UK

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Contract QP

ServicesTechnology

Transfer

Regulatory Services

Quality Management Investigations

Validation Services

Stability and

StorageManagement

API and supplier audits

GMP and QA

Training