Mast - Component Supplier Audit Checklist

• Site conducted

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• Facility:

• Audit Date & Time:

  Date

• Attendees:

• Auditor:

• Location:
  Address

RECEIVING

• 1. Are there written procedures for the receipt, identification, storage, handling, sampling, testing and approval of raw materials and labels?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• Yes

  No

  N/A

• 2. Are raw materials withheld from production until released by Q.C.?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 3. Are raw material samples labeled with lot number, container, the date and the person who collected the sample?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 4. Are COA’s required for raw material approval?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 5. Are representative samples of each lot of raw material pulled and tested/examined for physical and/or chemical characteristics as specified?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 6. Are bagged or boxed raw materials stored off the floor?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 7. Is FIFO used for raw materials?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 8. Is there a quarantine system for rejected raw materials designed to prevent their use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 9. Do you use any form of sterilization on raw materials?

  Yes

  No

  N/A

• 10. Do you recycle/reuse any raw materials in the manufacture of other components?

  Yes

  No

  N/A

CALIBRATION

• 11. Is there a procedure established to control, calibrate and maintain inspection, measuring, and test equipment (including testing software) that is used to demonstrate the conformance of product to specified requirements?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 12. Is there an instrument list of all the testinginstruments that require calibration?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 13. Is there documentation of periodic calibration of the testing instruments showing that the instruments were calibrated on schedule to a preset tolerance and with a traceable reference standard?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

PROCESSING AREA

• 14. Are there written production and process control procedures approved by the QC unit?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 15. Are there written procedures for the cleaning and sanitation of equipment?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 18

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 16. Is the cleaning/sanitization procedure validated?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 17. Are there cleaning/sanitization records for the equipment?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 18. Is the equipment cleaning/sanitization status labeled?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 19. Is the equipment inspected for cleanliness before use and documented in the production record?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 20. Is the production area free from materials from previous operations (line clearance)?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 21. Are there procedures to ensure correct mold/tooling is being used?

  Yes

  No

  N/A

• 22. Are all major equipment identified and documented in the batch production record?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 23. Are key processing steps and parameters documented in the production records?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 24. Is the compressed air that comes into component contact oil-free and micro filtered?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

PRODUCTION

• 25. Are proper drawings and specifications being used in production?

  Yes

  No

  N/A

• 26. Are labels held in quarantine until issued to the production area?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 27. Are in-process components identified with a label or tag?

  Yes

  No

  N/A

• 28. Is finished product examined during finishing to assure correct labeling or decoration?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 29. Do you have procedures for minimizing out-of-spec components and or out-of-spec labeling/decoration?

  Yes

  No

  N/A

• 30. Are finished product standards refreshed every 6 months?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 31. Are production samples retained for at least three years from manufacture?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 32. Are finished product standards stored in an environmentally controlled area to prevent product contamination and degradation?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 33. Are there procedures to control, use, and reconcile components that are undecorated, decorated, or labeled?

  Yes

  No

  N/A

• 34. Are labels and other proprietary components cleared, stored, and/or destructed post-production?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

HOLDING AND DISTRIBUTION

• 35. Are there written warehousing procedures describing quarantine of components or labels until approved by QC?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 36. Are rejected finished products status labeled or held in a quarantine area?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 37. Are there written procedures for disposal of rejected finished product in a manner that assures it is not used?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 38. Is there a SOP that describes the requirements for product release, specification compliance, samples and documents?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 39. Are transit testing trials conducted based on transportation methods typically used?

  Yes

  No

  N/A

• 40. Do you have procedures in place to ensure all components that are undecorated, decorated, and/or labeled are packaged, stored, handled, and transported in a way that will help minimize/prevent damage?

  Yes

  No

  N/A

LOSS PREVENTION

• 41. Are there adequate controls to prevent the loss of finished goods and/or componentry from the facility?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 42. Is facility access controlled and monitored after hours? Are the access records reviewed?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 43. Are procedures in place for the proper notification and destruction of unacceptable/obsolete finished goods and/or package components?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 44. Are products shipped in a controlled & secured manner to prevent tampering, contamination or loss during transit?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

BUILDING AND FACILITIES

• 45. The outside of the building is maintained free of trash and debris that provide harborage.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 46. The building size and construction facilitate cleaning maintenance and operations.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 47. There is adequate space to prevent mix-ups of component (ingredient)s, labels, materials, and to prevent contamination.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 48. Doors and windows are kept closed.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 49. Operations are performed within specifically defined areas to prevent contamination or mix-ups.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 50. Is there adequate lighting?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 51. Is there adequate filtered ventilation to production operations where product is exposed?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 52. There are adequate drains for equipment and to prevent standing water.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 53. The building is free of signs of infestation.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 54. There are written procedures for pest control including a drawing or floor plan showing the placement of control devices.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 55. Is the building maintained in a good state of repair?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

PRODUCTION RECORDS

• 56. Is the QC unit review of the records documented?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 57. Does the review result in a shipping release document?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 58. Was all testing completed before the shipping release was signed?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 59. For first production has the contract manufacturer established an internal procedure to identify the First Production? Give written notification at least 48 hours before start-up. Assure that before start-up there is an approved standard, approved specification, fill and assembly specification and packaging specification.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 60. Are production records retained for at least 4 years and/or the time period required by local regulations?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

REGISTERED FACILITY

• 61. Has the facility been registered with local governing agencies as a cosmetic, chemical, or similar manufacturing facility and has received approval to manufacture legally within the guidelines as specified by the registration?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 62. Has the facility been certified, under local governing agencies and/or to a international standard for the manufacturing of cosmetic, chemical or similar products? (Ex. IS0 9001, ISO 22716, USFDA, Korean FDA, China FDA, etc.)

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 63. When was the last local FDA inspection? Have any major non-compliances and/or fines been issued in the past 10 years? (Ex. FDA-483)

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 64. Are production records retained for one year past expiration date?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 65. Are there written procedures for an annual review of written records; batch production records, complaints, recalls and investigations?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 66. Is there a record of the most recent required review for Mast products? Or an example of a review from a similar customer?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 67. Are their established requirements and/or certifications required for all subcontractors and suppliers?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

QUALITY CONTROL

• 68. Does the facility have a Quality Manual? Is the manual updated and audited through change control?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 69. Does the QC unit have written procedures to approve or reject all component raw materials, containers, closures, in-process materials, packaging material, labeling, and finished products?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 70. Are adequate laboratory facilities available to the QC unit for testing and approval or rejection of all component raw materials, in-process materials, packaging material, labeling, and finished product?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 71. Does the QC unit approve all procedures and specifications impacting the identity, strength, quality, and purity of the product?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 72. Does the QC Unit review production records prior to release or shipping the product?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 73. Is there history of internal and/or external quality holds, withdrawals or recalls?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 74. Is there an appropriate CAPA system in place to identify and resolve quality based issues?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 75. Are finished goods inspected properly by QC prior to release for shipping?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 76. Does the vendor audit their raw material suppliers?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

PERSONNEL QUALIFICATIONS

• 77. Is there a record of training in GMP and in the particular operations each employee performs?1

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 78. Is the training conducted by a qualified individual and is a retraining cadence specified?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 79. Do the personnel use protective apparel such as head, face and arm coverings properly to prevent product contamination?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

SIGN-OFF

• Auditor E-Signature & Date:

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