About Global Quality Alliance

A team of highly qualified Quality Systems Consultants...

Global Quality Alliance is an association of highly qualified quality systems consultants serving the pharmaceutical, biotechnology, API, biochemical, dietary supplement, and medical device industries.

Our consultants have many years of experience, not only in quality assurance (QA), but also in manufacturing, laboratories, technical services and supervision/management. Additionally, we have numerous associate consultants that complete our ability to offer our clients a full range of consulting services.

Our consulting services can provide the expertise, skills, objectivity, and experience to help evaluate, improve, or build our client's cGMP quality systems and regulatory compliance. We maintain our knowledge base in current industry standards, guidelines, and regulations. By regularly participating in industry associations such as PDA, ISPE, and ASQ, we are exposed to the leading regulatory and industry experts and information.

Quality systems development or improvement is the goal of everyone in the industry. We can help with the writing or revision of SOPs, specifications, and other quality procedures. We can provide basic or specific GMP training or training on programs such as change control, deviations, or auditing.

Auditing remains a key tool in ensuring quality compliance to regulations, guidelines, internal standards, and industry expectations. The availability of auditors who provide useful and relevant information and have the experience and skills is often an unmet need in the industry. Internal audits by our skilled quality auditors, trained through the ASQ Certified Quality Auditor program, help identify problems and weaknesses that can be addressed and corrected without regulatory consequences. Our auditors are skilled in the requirements of GXP (GMP, GLP, GCP) systems.

With the trend toward virtual companies that utilize contract manufacturing to produce their products,Global Quality Alliance can provide auditors that can increase or develop confidence and knowledge in partnership arrangements with subcontractors and contract manufacturers.

Supplier management requires qualification and audits of critical raw material, API, component, and service providers. We have performed audits of suppliers covering a wide range of materials and services. Our detailed audit evaluation reports are a valuable part of our client's supplier qualification process.

Call or e-mail us to discuss your individual needs.

Quality Assurance:
A planned and systematic
set of activities to ensure
that requirements are clearly
established and the defined
process complies to these
requirements.

This includes activities to
ensure that variances in
processes are clearly
identified, assessed and
improved.

For drug products, these
activities and actions are
necessary to assure that
the product meets all
requirements as to
strength,purity, and
efficacy.

Quality Systems Assessments:
Utilizing defined audit
methods for quality systems
assessments, we are able to
fairly evaluate your quality
practices. We identify
opportunities that enable you
to achieve, maintain and
improve quality in your
operations

Continuous Quality Improvement - CQI:
A key component of
continuous quality
improvement is reliable,
accurate auditing of
the people, processes
and technologies used
to manufacture
pharmaceutical and
biotechnology products.