Company Info

Company Name

Description of Business

Phone Number

Fax Number

Email

Sales Key Contact

QA/QC Key Contact

Customer Service Key Contact

Product Liabilty Insurance

photo of liability insurance

Current cGMP Certificate

photo of current 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 Numbers

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?

In the last 3 years, have you received and FDA warning letters?

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

Building & Facilities / Production & Process Controls

Is a pest control program in place?

Do you have SOP's documenting pest control procedures?

Proper storage of pesticides?

Map of facility indicating trap, bait stations, etc?

List of approved pesticides and MSDS sheets?

If you work with Organic products, is your pest control aware of Organic activites?

Do you have this in writing?

Documented scheduled inspections?

Do you have cross contamination control?

MSDS sheets available to your employees?

Do you have job descriptions?

Humidity 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 preventive maintenance procedure for equipment in place?

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

Is there GMP training in place?

Is there written records of the training?

Is there a system for the quarantine of incoming materials?

Are raw materials properly identified?

Are raw materials sampled and tested?

Are rejected materials identified and controlled via written procedure?

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, how 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 batch?

Are written procedures in place for the in-process monitoring of a batch?

Do you have written SOP's 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?

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 a 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, AOAC when applicable?

Are records of all test results kept?

Are there written procedures in place for the investigation of out of 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?

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 utilized the services of an outside, independent laboratory?

Name of the laboratory used:

For analytical testing?

For microbiological testing?

Please briefly describe your procedure for certifying this laboratory.

Does 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

Facility & Grounds

Anti-siphon devices on water outlets?
21 CFR 111.15(f(5))

Shrubs are spaced away from outer walls?
21 CFR 111.15(a(1))

Rubbish is contained and grounds are clean?
21 CFR 111.15(a(1))

Entries into the facility are designed to prevent pest from entering the facility?
21 CFR 111.15(d(2))

Restrooms clean and sanitized?
21 CFR 111.15(h)

Company has and follows SOP's for cleaning and maintenance of the facility and grounds?
21 CFR 111.16

Other Issues Found:

Misc. Photos
Receiving Department

Quarantine area controlled or locked?
21 CFR 111.120(e), 111.155, 111.160, 111.165, 111.170, 111.370, 111.425, 111.510

Quarantine area clean & organized?
21 CFR 111.15(b(1))

Company has an acceptable area or room for taking samples?

Receiving log is documented correctly and up to date?
21 CFR 111.180(b(2))

Raw material check-in log is documented correctly and up to date?
21 CFR 111.180(b(2))

Packaging material check-in log is documented and up to date?
21 CFR 111.180(b(2))

Label check-in log is documented correctly and up to date?
21 CFR 111.180(b(2))

Finished product check-in log is documented correctly and up to date?
21 CFR 111.180(b(2))

Company has and follows SOP's for receiving and quarantine?
21 CFR 111.153

Other Issues Found:

MIsc. Photos
Warehouse

Doors leading to outside are closed?
21 CFR 111.15(d(2))

All materials are stored off the floor?
21 CFR 111.365(f)

All components bear a release sticker?
21 CFR 111.155(c(3))

All containers are properly closed?
21 CFR 111.365(f)

Warehouse floor is clean and free of debris?
21 CFR 111.15(b(1))

ID tags are visible from isles?
21 CFR 111.20(c(1))

All pallets identified with proper tags?
21 CFR 111.20(c(1))

Empty containers have labels removed or defaced?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Tube guards on lights and all lights working properly?
21 CFR 111.120(f)

In process materials are clearly labeled?
21 CFR 111.20(c(1))

Empty pallets are properly and neatly stored?

Pest control devices are not damaged and traps in place?
21 CFR 111.15(d(2))

Scales, if applicable, have a current calibration sticker?
21 CFR 111.30(c)

Pallet racks are mounted away from the walls to allow for cleaning between wallsand racks?
21 CFR 111.20(b)

Tops of all containers are free from debris and residual dust?
21 CFR 111.15(b(1))

Other Issues Found:

MIsc. Photos
Weighing Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

In process product is covered and labeled?
21 CFR 111.460(a)

Only one product in a room at a time?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Component cards are up to date?

Other Issues Found:

Misc. Photos
Blending / Compounding Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Tablet Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Tablet Coating

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Encapsulation Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Softgel Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Polish / Inspect Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Packaging Department

Floors / walls clean and undamaged?
21 CFR 111.15(b(1)), 111.15(b(2))

Lights are clean, undamaged and have tube guards?
21 CFR 111.20(f)

Employees properly gowned and hairnets?
21 CFR 111.10(b(6))

Only one product in a room at a time?
21 CFR 111.460(a)

In process product is covered and labeled?
21 CFR 111.460(a)

Scales have current calibration sticker?
21 CFR 111.30(c)

Daily scale check is documented and up to date?
21 CFR 111.30(c)

Paperwork properly documented?
21 CFR 111.260(j)

Room cleaning and use records are up to date and completed correctly?

Trash receptacles are clearly marked and emptied when full?
21 CFR 111.15(j)

Dust collector is adequate and working?
21 CFR 111.120(d(iii)))

Other Issues Found:

Misc. Photos
Maintenance Department

Unused equipment is properly covered and stored?

Washroom is kept clean and organized?

Maintenance records for all equipment?

Maintenance records are up to date?

Maintenance tools, supplies and lubricants/liquids are properly stored and approved for use?
21 CFR 111.15(c)

Other Issues Found:

Misc. Photos
Quality Control Laboratory

Instrument logs are up to date and complete?
21 CFR 111.35(b(2,3))

Calibration stickers on all pertinent equipment?
21 CFR 111.35(b(3))

Lab notebooks up to date and complete?

Scales are calibrated and checked daily?
21 CFR 111.35(b(3))

Employees wearing lab coats?

Lab kept clean and organized?

Sinks and area clean?

Other Issues Found:

Misc. Photos
Quality Assurance

Retain samples are kept and stored properly?
21 CFR 111.465

Retention room up to date and clean?

Scale calibration system documented?
21 CFR 111.35(b(3))

Enforcement of employees not wearing earrings, jewelry, fake nails?
21 CFR 111.10(b(4))

Enforcement of employees to wear gloves and hairnets at all times?
21 CFR 111.10(b(6))

Quality assurance personnel have outlined duties (SOP's) to direct them in enforcing GMP's and SOP's?
21 CFR 111.10(b(6))

Vendor qualifications are properly documented?
21 CFR 111.75(a(2(ii(A-E))))

Investigations are performed as required by GMP's?
21 CFR 111.135, 140, 530

Other Issues Found:

Misc. Photos

Documents Review

Manufacturing records are complete with no errors?

Test records for in-process stages?

Distribution records for products/raw materials?

Certificate of Analysis for raw materials?

Master files with all GMP requirements?
21 CFR 111.210

Training records are up to date?
21 CFR 111.14(b(2))

Other Issues Found:

Misc. Photos

Notes & Acknowledgement

Notes

Misc. Photos
Vendor
Simpson Industries Quality Assurance

Executive Summary

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

Conclusion

Recommendations & Action Plan

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.