Supplier Assessment Checklists A Tool for Vetting Vendors and Contractors
You’re ultimately responsible for the quality of your end product, but how do you know if your suppliers and contractors can meet your quality standards? Your vetting of these companies must be thorough and comprehensive.
Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors includes two checklists — the API Supplier Checklist — and the Contract Manufacturing and Analysis Checklist — that will guide you through the process so that you don’t have to worry about missing any points or asking the wrong questions.
The API Supplier Checklist helps you gather detailed information on the companies you are considering to provide you with the critical components of your drug products including:
Risk management and change control procedures
Condition of facilities and equipment
Documentation and recordkeeping
Materials handling and storage
Work performed for other clients that could affect your materials
The Contract Manufacturing and Analysis Checklist helps you gather information on a company’s:
Certifications and standards
Regulatory inspections and their outcomes
Sampling and testing procedures
Equipment qualification and process validation
Computerized systems and software
The checklists arewritten by two industry experts with more than 30 years of combined experience. Christine Oechslein (pharmacist) provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. Cornelia Wawretschek (quality assurance consultant) advises pharmaceutical and biotechnology companies during the development and update of pharmaceutical quality systems.
You will learn:
How to make sure your suppliers are compliant with pertinent GMP regulations and standards
How to determine if their failure investigation processes are adequate
How to assess the training of their personnel
What SOPs to review
How to evaluate a contract manufacturer that doesn’t have a site master file
These easy-to-follow checklists can be adapted to meet you own needs as well as form the base of your documentation on individual suppliers and contractors.
Order your copy of Supplier Assessment Checklists and be completely confident in your selection of suppliers and contractors.
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PDF Edition — $197
Who Will Benefit
Quality control department
Regulatory compliance department
About the Authors
Christine Oechslein, Pharmacist, GMP-Praxis
As a freelance GMP trainer, Christine Oechslein provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. She has worked in the pharmaceutical industry for many years. As a speaker for different event organizers and an author, she shares her GMP knowledge in the areas of process validation, GMP training and GMP in development.
Cornelia Wawretschek, GxP-Services, Berlin
Cornelia Wawretschek is a quality assurance consultant with 15 years of experience in the areas of pharmaceutical processes and analysis, with a focus on the development of semi-solid and liquid dosage forms, sterile production and investigational medicinal products. She advises pharmaceutical and biotechnology companies during the development and update of pharmaceutical quality systems, focuses on the preparation and follow-up of official inspections, the development of modules for planning and managing training and the implementation of training measures.
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