Mast - Contract Manufacturer Audit Checklist

• Site conducted

  Select

• 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 components (ingredients),packaging materials, and Labels?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 2. Are components (ingredients), containers and closures withheld from production until released by Q.C.?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 3. Do incoming fragrance oils have unique handling requirements, including inspection, testing, and release criteria.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 4. Are components (ingredients) status labeled or held in a quarantine area until released for use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 5. Are packaging materials status labeled or held in a quarantine area until released for use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 6. Is there a representative sized sample taken?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 7. Are the component (ingredient) containers cleaned before sampling?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 8. Are the components (ingredients) sampled and resealed in a manner and in an area designed to prevent contamination?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 9. Are component (ingredient) 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

• 10. Are the components (ingredients) tested by at least one identity test?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 11. Are COA’s required for component (ingredient) approval?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 12. Are COA's obtained for packaging components and labels?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 15. Is FIFO used for component (ingredient)s, containers and closures?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 16. Is there a system to identify expired component (ingredient)s and quarantine them to prevent their use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 17. Is there a quarantine system for rejected component (ingredient)s and packaging materials designed to prevent their use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 18. Are fragrance oils reinspected prior to use to ensure oil still meets standard?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

WEIGH AREA

• 19. Are there written procedures for weighing, labeling (the intermediate container) and documenting the weighing of components (ingredients)?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 20. Is the reproduction of the master production record, checked for accuracy, dated and signed?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 21. Is the intermediate component (ingredient) container labeled with; name or code, control number, weight, and batch for which it is designated?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 22. Is the component (ingredient) weighing examined by a second person for component release, for correct weight as in production record, and for correctly labeled container?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 23. Is the weigh area a controlled environment to prevent contamination of open containers of components (ingredients)?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 24. Are the intermediate containers constructed of appropriate materials to prevent contamination and to facilitate cleaning?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 25. Are batch adjustments documented as part of the batch record?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

CALIBRATION

• 26. Are there written procedures for calibration of weigh scales and other measurement instruments?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 27. Is there an instrument list of all the measurement instruments that require calibration?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 28. Is there documentation of periodic calibration of the measurement 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

INGREDIENT WATER SYSTEM

• 29. Are there written procedures for the operation, cleaning, maintenance and sanitization of the ingredient water system?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 30. Is the ingredient water system validated and follow USP (FDA) guidlines for Purified Water?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 31. Is there a diagram of the water system showing all sample points and use points?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 31. A. Is the ingredient water system free of deadlegs and constructed of material to prevent contamination

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 32. Is there an ongoing water quality monitoring program with alert and action limits?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

PROCESSING AREA

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 34. Are product production processes (manufacturing instructions / processes) validated by both the factory and R&D?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 36. Is the cleaning/sanitization procedure validated?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 40. Is the equipment located to facilitate operations, cleaning and maintenance?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 41. Is the equipment constructed of appropriate materials to prevent contamination and to facilitate cleaning?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 42. Is the equipment designed to prevent contamination with lubricants and coolants?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 44. Is the component (ingredient) addition verified by a second person?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 45. Are key processing steps and parameters documented in the production records i.e.. mixing speed, mixing times and temperatures?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

FILLING AND PACKAGING AREA

• 46. Are there written filling and packaging control procedures approved by the QC unit?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 47. Are product filling processes (manufacturing instructions / fill and assembly) validated by both factory and R&D?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 48. Is line clearance between batches documented?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 49. Are there written procedures for the cleaning and sanitization of filling equipment?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 50. Are cleaning and sanitization methods validated to prevent chemical residue on equipment?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 51. Are the cleaning and sanitization procedures for filling equipment validated?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 52. Are there cleaning/sanitation records for the filling equipment?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 53. Is the equipment inspected for cleanliness before use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 54. Is the equipment located to facilitate operations, cleaning and maintenance?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 55. Is the equipment constructed of appropriate materials to prevent contamination and to facilitate cleaning?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 56. Is the equipment designed to prevent contamination with lubricants and coolants?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 57. Is the compressed air that comes into product contact or contact with primary containers or other product contact surfaces oil-free and micro filtered?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 58. Are actual yield calculations determined at the end of filling and verified by a second person?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 61. Is finished product examined during finishing to assure correct labeling?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 64. 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

HOLDING AND DISTRIBUTION

• 65. Are there written warehousing procedures describing quarantine of manufactured products (bulk or finished goods) until approved by QC?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 66. Is rejected finished products status labeled or held in a quarantine area?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 67. 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

• 68. 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

• 69. Is there a SOP or system to limit the storage of manufactured bulk for a validated period of time?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 70. If stored for a period of time, is bulk retested for micro prior to use?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

LOSS PREVENTION

• 71. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 73. 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

• 74. 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

• 75. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 77. 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

• 78. Doors and windows are kept closed.

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 80. Is there adequate lighting?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 84. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

BATCH PRODUCTION RECORDS

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 89. Is the Formula change control documented?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 91. Are all batch related instructions and forms combined into a comprehensive batch packet? Are records retrievable within 24 hours?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 92. Are batch records for 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

• 93. 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

• 94. 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

• 95. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 97. 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

• 98. 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

• 99. 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

• 100. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 103. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 106. Is batch data trended to ensure processes are in control?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 107. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

PERSONNEL QUALIFICATIONS

• 110. 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

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

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 112. 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

DEVELOPMENT TESTING

• 113. If applicable, are OTC products formulated to provide not less than 100% of the labeled amount of active ingredient?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 114. Was preservative challenge testing completed on the product formulation prior to first production?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 115. Was RIPT testing completed before first production? (Human Repeat Insult Patch Test)

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 116. Is there a written stability program? Does this stability program meet Mast stability testing protocols?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 117. Is there documentation of the setting of the tentative expiration date?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 118. Is the DOT hazardous material labeling assessment documented?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 119. Are there actual shelf life studies underway to support the tentative expiration date?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 121. Is there preservative challenge testing on aged samples to show the preservative effectiveness at expiration?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

• 120. If applicable, is there a test method validation for the active ingredient assay?

  Compliant

  OFI

  Minor N/C

  Major N/C

  N/A

SIGN-OFF

• Auditor's Name & Signature:

  Sign