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GMP Compliance, Regulatory Affairs & Validation Consulting and Training

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GMP
QSG offers practical, simple GMP, Validation and Regulatory solutions for companies seeking to obtain a competitive advantage.

Our philosophy is simple - advise on or write concise quality systems or validation protocols that tell your team what to do and then make sure you or your team do what has been written.

If you are looking for GMP Consultants or Validation Consultants that will build an effective quality system then QSG is for you.

Please read more about our range of services below. We offer GMP regulatory advice, practically applied. 

What we offer:

Training to the Pharmaceutical and Medical Device industries

  • We offer a wide range of Validation, GLP training and GMP training courses.

  • Our extensive range of training courses include GAMP 5 training, ISO 13485 training and Q9 / ISO 14971 quality risk management training courses.

People

  • Outsourced consultants to work on your site under your direction at short notice for short or long duration projects.

  • We have Pharmaceutical Engineers, GMP Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice at competitive rates.

GLP/GMP Compliance

  • GLP/GMP Quality Management Systems, GAP audits and assessments

  • Practical recommendations and advice on the implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOPs and Forms.

  • Pharmaceutical Maintenance - we can audit your engineering department for compliance to TGA, FDA and ISPE baseline recommendations.

  • We can assist with Veterinary Drug GMP compliance to the APVMA GMP code. 

Validation - Process, Equipment, Cleaning & Computer

  • Pharmaceutical and Medical Device Process Validation to TGA and FDA regulations

  • Pharmaceutical Equipment Validation to international regulatory standards and in accordance with current Good Manufacturing Practice.

  • Cleaning Validation for pharmaceutical and medical device manufacturing facilities

  • Computer Systems Validation to FDA Part 11 and TGA Annex 11 regulations

QA Consulting Services

Auditing 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


  • 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



   
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