Company Information

  • Company Name

  • Description Of Business

  • Phone Number

  • Fax Number

  • Email

  • Sales Key Contact

  • QA/QC Key Contact

  • Customer Service Key Contact

  • Product Liability Insurance

  • Photo of Liability Insurance

  • Current cGMP certification

  • cGMP certificate

Organization

  • Is there a Quality Assurance program in place?

  • Is the QA/QC group independent of manufacturing?

Approximate Number of Employees

  • Total Employment

  • QA/QC Regulatory

  • Engineering

  • Research/Development

  • Manufacturing

  • Packaging

  • Administration

Regulatory

  • Is your facility registered with any governing bodies?

  • Governing Bodies and Registration Number

  • List any related certifications received by your company (e.g. ISO-9000, GMP, etc):

  • Has your facility been audited by the Federal or State FDA within the last 3 years?

  • If yes, when?

  • Was a 483 report or state equivalent issued?

  • In the last 3 years have have you received any FDA warning letters?

  • Is your company operating in compliance with 21 CFR part 110/111?

  • 110 is Food cGMP's / 111 Dietary Supplement cGMP's

Building and Facilities / Production and Process Controls

  • Is a pest control program in place?

  • SOPs documenting pest control procedures?

  • Internal or external pest control licensed applicator

  • Proper storage of pesticides

  • Map of facility indicating trap, bait stations, etc.

  • List of approved pesticides and MSDS

  • Documented scheduled inspections

  • Do you have cross contamination control

  • MSDS available to your employees

  • Do you have job descriptions

  • Humidty Control

  • Temperature Control

  • Water purification system

  • Are written procedures for cleaning of equipment and work areas in place?

  • Are records of these cleanings maintained in a log?

  • Is a preventative maintenance procedure for equipment in place?

  • Is there a clearance performed on rooms/equipment prior to production?

  • Is there a GMP training in place?

  • Is there written records of the training?

  • Is there a system for the quarantine of incoming materials?

  • Are raw materials sampled and tested?

  • Are materials properly identified?

  • Are rejected materials identified and controlled via written procedure?

  • Do you have records on receipt of your raw materials?

  • Do you have an SOP for sampling?

  • Are written procedures in place for the control and release of materials and product?

  • Is QA/QC responsible for these controls?

  • Are batches assigned a unique identification lot number?

  • If yes, how are lot numbers assigned and how are they decoded?

  • Do you combine batches into one lot?

  • If yes, are they traceable?

  • Do you establish and keep records for all phases of the manufacturing process?

  • Do these records include manufacturing instructions?

  • Are these records reviewed by QA/QC prior to release of a batch?

  • Are written procedures in place for the in-process monitoring of batches?

  • Do you have written SOPs established for critical steps of the manufacturing process?

  • SOP index photo

  • Are deviations from established manufacturing procedures documented and approved prior to execution?

  • Are reworks of rejected materials documented and approved?

  • Is there a procedure for the quarantine and disposition of rejected materials.

  • Are retain samples taken from each lot?

  • Is there a documented change control procedure in place?

  • Do you have equipment cleaning and use logs?

  • Do you have equipment maintenance logs?

  • Do you have a documented equipment calibration program?

  • Do you have batch production and control records?

  • Do you have raw materials inventory tracking?

  • Do you have master production and control records?

  • Are materials and equipment identified throughout process?

  • Is equipment cleanliness identifiable?

  • Do you have an SOP for line set up and approval?

  • Do you have an SOP for product sampling?

  • Do you have components inspection program?

  • Is there a procedure for label control?

  • Is there a procedure for the proper labeling of finished product?

  • Do your labels contain lot numbers and expiration dates?

  • Are written procedures in place for warehouse and distribution control?

  • Do you have a procedure for handling customer complaints?

  • Do you document the investigation and resolution of customer complaints?

  • Do you conduct internal cGMP compliance / quality audits?

Quality Control Laboratory

  • Do you have an in-house analytical laboratory?

  • Do you have an in-house microbiology laboratory?

  • Are written lab procedures in place?

  • Do you follow official test methods such as USP when applicable?

  • Are records of all test results kept?

  • Are there written procedures in place for the investigation of out os Specification results?

  • Is this investigation documented?

  • Do you have a raw material testing program?

  • Are raw materials compared to vendor's COA?

  • Do you perform in-process testing?

  • Do you perform raw material and product specifications?

  • Do you have packaging component specifications?

  • Are QC samples identified and retained?

  • Do you have raw material and product test records?

  • Are your assay methods validated?

  • Do you have an instrument calibration and maintenance program?

  • Do you have a lab standards program?

  • Do you utilize the services of an outside, independent laboratory?

  • For analytical testing?

  • For microbiological testing?

  • Name of the laboratory used:

  • Please briefly describe your procedure for certifying this laboratory.

  • Do your certificate of analysis contain the following:

  • Expiration Dates?

  • Date of manufacture?

  • Country of origin of materials?

  • Data testing performed?

  • How long are retention samples kept for?

  • Do you keep lab notebooks?

Facility Walk Through Observations

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Document Records Review

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Notes

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Acknowledgement

  • Vendor

  • Simpson Industries QA

Executive Summary

  • This summary provides information pertaining to the onsite audit and discussions related to the vendor's compliance with the guidance set forth in 21 CFR Part 111 GMPs and opportunities for improvement in current relationships with the vendor.

Background / Introduction

  • Simpson Industries seeks to strengthen manufacturer-vendor relations by periodically auditing its vendors via questionnaire and on-site visits.

Aims & Objectives

  • The objective of the audit is to reinforce Simpson's current relationship with the vendor and discuss the incorporation of new policies and requirements therein. This audit also serves to provide visual support for the vendor's responses to the pre-audit questionnaire.

Results

Conclusions

Recommendations and Action Plans

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