(GMP) FM-5 Artisan Labs Supplier Questionnaire

Company name:

Years in business:

Number of employees (approx.):

Company website address:

Name of representative completing this questionnaire:

Job position/role:

Email address:

Provide a brief description of your QMS:

Describe the Quality Control measures in place for packaging materials (e.g. bottles, caps, etc.):

Please list:

Please provide a brief description of these procedures:

How do you manage and control non-conforming materials, and what steps do you take to prevent recurrence of issues?

Please provide examples:

What are your standard lead times for orders?

Describe your approach to handling urgent orders or expedited delivery requests:

Describe the range of raw materials offered (e.g., active pharmaceutical ingredients (APIs), pharmaceutical excipients, etc.):

Provide a brief description of your QMS:

Describe your manufacturing process and facilities:

How do you ensure the consistency and quality of raw materials during production?

please provide details:

How do you ensure the quality and purity of your raw materials (e.g., in-process testing, final product testing, etc.)?

Do you provide Certificates of Analysis (CoA) for each batch of raw material supplied?

Please provide details:

How do you manage and control non-conforming materials, and what steps do you take to prevent recurrence of issues?

Describe your process for qualifying and monitoring your own suppliers and subcontractors:

How do you ensure the traceability of raw materials throughout the supply chain?

Please describe process:

Describe the range of raw materials distributed (e.g., active pharmaceutical ingredients (APIs), pharmaceutical excipients, etc.):

Provide a brief description of your QMS:

Describe your process for qualifying and monitoring your raw material manufacturers:

How do you ensure the traceability of raw materials throughout the supply chain?

How do you ensure the quality and purity of your distributed raw materials (e.g., storage conditions, handling, transportation, etc.)?

Please provide details:

Describe your storage facilities and conditions for raw materials:

How do you ensure the proper handling and transportation of raw materials to maintain quality and prevent contamination?

Please describe process

What environmental and sustainability initiatives do you have in place?

How do you ensure ethical labor practices within your organization and supply chain?

Describe the range of analytical services offered (e.g., sampling tests, stability trials, etc.):

Provide a brief description of your QMS:

How do you handle corrective and preventive actions (CAPA) within your QMS, and how do you track their effectiveness?

Please describe your experience

Please provide details:

Describe your procedures for sample receipt, storage, and disposal:

How do you ensure the proper chain of custody for samples throughout the testing process?

What measures do you have in place to ensure data integrity and traceability?

Describe your approach to reporting test results, including turnaround times and report format:

How do you ensure the quality and accuracy of your testing services?

Describe your procedures for managing non-conforming test results or deviations from standard procedures:

Describe the range of printing services offered (e.g., commercial label manufacturing, digital printing, offset printing, etc.):

Provide a brief description of your QMS:

Describe the printing equipment and technology used in your facility:

How do you ensure consistent quality and color accuracy in your printing process?

What quality control measures do you have in place for printed materials (e.g., inspections, testing, etc.)?

Please provide details:

What environmental and sustainability initiatives do you have in place (e.g., recycling, waste reduction, energy efficiency, etc.)?

What is your typical lead time for new orders and reorders?

What is your production capacity, and how do you handle peak periods or high-demand situations?

Describe the range of cleaning services offered (e.g., industrial cleaning, facility maintenance, specialized cleaning, etc.):

Provide a brief description of your QMS:

Describe the training and certification process for your cleaning staff:

How do you ensure that your cleaning staff is knowledgeable about specific cleaning requirements and safety regulations?

What quality control measures do you have in place for your cleaning services (e.g., inspections, audits, etc.)?

Please provide details:

What environmental and sustainability initiatives do you have in place (e.g., green cleaning products, waste reduction, energy efficiency, etc.)?

Describe your process for developing a Service Level Agreement (SLA) and tailoring your services to specific client needs:

What is your capacity for handling multiple contracts or high-demand situations?

Describe the range of manufacturing services offered (e.g., intermediate products, APIs, finished products, etc.):

Provide a brief description of your QMS:

Describe your manufacturing facilities, including any cleanroom environments:

Describe the equipment and technology used in your facility:

How do you ensure GMP compliance throughout your manufacturing processes?

Describe your process for handling regulatory submissions and maintaining regulatory compliance:

What quality control measures do you have in place for manufactured products (e.g., inspections, testing, etc.)?

Please provide details:

Describe your process for managing raw materials and suppliers:

What is your production capacity, and how do you handle peak periods or high-demand situations?

Describe the range of calibration services offered (e.g., process equipment, analytical instruments, temperature-controlled equipment, etc.):

Provide a brief description of your QMS:

Describe the technical expertise of your calibration staff:

Explain the training and certification process for your calibration technicians:

Describe the calibration standards used and their traceability to national or international standards:

Explain your process for maintaining and updating calibration standards:

What quality control measures do you have in place for your calibration services (e.g., inspections, audits, etc.)?

Please provide details:

What is your typical turnaround time for calibration services?

please provide details:

List the main security services your company provides (e.g., armed guards, unarmed guards, access control, etc.):

Describe any specialized services or industry-specific expertise your company offers:

What geographic areas do your services cover?

Provide details of any insurance coverage your company maintains (e.g., General Liability, Workers' Compensation, etc.):

Describe your process for recruiting and screening security personnel:

Detail the training programs and ongoing professional development opportunities provided to your security personnel:

Outline your standard operating procedures for handling security incidents:

Describe the technology and equipment used by your security personnel (e.g., cameras, access control systems, etc.):

Explain how your company maintains communication with clients during emergencies and security incidents:

Provide examples of relevant experience working with clients in our industry or with similar security needs:

List three client references, including contact information (if permitted):

List the main products and services your company provides:

Describe any specialized services or industry-specific expertise your company offers:

What geographic areas do your services cover?

Describe your quality control and testing procedures:

Describe your supply chain management and traceability processes:

provide details:

Describe your quality assurance and continuous improvement processes: