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GQA Services

What can GQA do for you?

QA Consulting Services

  • Quality System Development

  • QA Management Responsibilities

  • SOP/Procedure Development and Review

  • Batch Record Review and Approval

  • Risk Management

  • Change Control Program

  • FDA 483 Response Support

  • CAPA Development/Support

  • Quality Manual Development

  • Vendor/Supplier Qualification

  • Project Management

  • Validation Review

  • Equipment/Utility Validation

  • Process Validation

  • IND/NDA/BLA Review

  • CMC Review/Development

  • Compounding Pharmacy Quality System Development

  • Dietary Supplement cGMP Compliance

 
Auditing Services

  • Internal cGMP Audits

  • GLP Audits

  • GCP Audits

  • Contract Manufacturer Audits

  • Quality Systems Evaluation

  • Compliance Gap Assessments

  • Mock FDA Audits

  • Compounding Pharmacy Audits

  • Pre Approval Inspection Support

  • API ICH Q7A Audits

  • ISO 9001:2000 Audits

  • Labeling/Packaging Audits

  • Supplier Audits

  • Surveillance Audits

  • Validation Audits

  • Design of Audit Programs

  • Dietary Supplement Compliance Audits

 
Quality Control Consulting

  • GLP Compliance

  • Process Development Support

  • Analytical Method Development

  • Analytical Method Transfer

  • Analytical Method Validation

  • Formulation Development
Training

Global Quality Alliance offers a number of training programs designed to enhance the skills of your company's professionals.

 Click Here to view the training programs offered

 

 

 

Global Quality Alliance, LLC - revision 11/2009

 

 

Compounding Pharmacy

USP<797> (Pharmaceutical Compounding - Sterile Preparations) became effective in 2004. 460.200 - Pharmacy Compounding Guidance was issued by FDA in 2002. The FDA has issued Warning Letters to pharmacy compounding facilities in violation of requirements outlined in <797> and 460.200, and FDA oversight of compounding facilities has increased. GQA can provide expertise in auditing to meet these requirements as well as design and develop procedures, systems, and facilities.

21CFR 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

The Food and Drug Administration (FDA) has issued a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements being taken to promote and protect the public health.

21CFR 111 applies to both domestic and foreign companies that manufacture, test, package, label, hold, or distribute dietary supplements in the United States. Compliance enforcement to the regulation will be phased in, based on company size, over 3 years.