Information
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This application has been developed to record and report the GMP & EOHS Audit in the Research Center
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Select the appropriate answer for the specific items of the Audit Checklist
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Audit Title
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Conducted on
Audit information
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Area Audited
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- Liquids
- Solids
- Emulsions
- Aerosols
- Filling room
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- R&D
- Performance Lab
- Analytical
- Microbiology
- Packaging
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Auditor Leader
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Audit Team Members
Definition of ratings
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C - Compliant, meet expectations, no issues observed.
IO - Isolate observation, issues observed are considered isolated events, excursions to the policy, human errors. (1 finding was found)
SO - Systematic observation, significant number issues or deviation to the policy were observed.(2 findings were found)
AI - Administrative Issue, observations suggests lack of attention to the policy, intentional deviation to the policy. (3 findings were found)
LS - Lack of System, missing SOP, engineering solution required, budge may be required. (4 or more findings were found)
Total rating of GMP Audit
People
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Are personnel in the area dressed appropriately for the job?<br>Check for the following:<br>Availability of necessary clothing <br>· Lab coats <br>· Gloves <br>· Safety glasses <br>· Safety shoes <br>· Mouth Covers <br>
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Safety
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Appropriate safety systems, shower, and eyewash that are routinely checked.
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Are there clearly marked and unobstructed fire extinguishers?
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Is personnel using indicated cloths as per GMP Working Standard in clean and neat conditions? Do people have knowledge of minimal safety behaviors?
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Environment
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Is the area maintained in good housekeeping and kept in clean, neat, orderly and sanitary fashion?
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Are offices and conference rooms free of chemicals, insecticides, and other materials?
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Is the area free of food and beverages?
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Is the area equipped and supplied with proper sanitary products?
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Are trash bins labeled with the contents to be placed inside?<br>
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Equipment and utensils
Installation, design, services, calibration, verification and operation
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Are all measurement devices and equipment calibrated, verified and qualified?
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Are all equipment maintained to ensure it is operational condition as per requirements and intended use?
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Are there sinks and exhaust hoods available? <br>
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Does each drawer have an identification of its content?
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Is the equipment correctly identified?
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Use, cleanliness, status
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Are equipment, glassware, utensils, etc. clean where materials and/or formula are handled?
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Are Pilot Plant equipment kept clean by user at the end of the work assignment, and equipment be showed status of use and cleanliness?
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Are hoses not be left on floors when not in use and not be placed in drainage?
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Are hoses not in use be dried and covered to avoid exposure to water, air and other sources of cross-contamination?
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Material Handling
Storage, identification, disposition.
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Are the materials properly labeled or identified? (Including manufacturing date, expiration date, responsible and identification)
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Is there a specific area for materials as per its status?
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Are materials, formulas, and packaging materials covered to ensure their integrity? (except when handled for immediate use)
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Are Expired materials located in the disposal area?<br>
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Handling
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Are Expired materials not be used and be located in the disposal area?
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Are unattended, unlabeled and/or expired materials be transferred to disposal area?
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Are all personnel handling wear clean gloves when opening containers of micro- sensitive products and raw materials?
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
GMP Restrictions
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Are not presences of food, drinks and chewing gum in Experimental Areas and Store Rooms?
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Are not presence of personal belongings such as jackets, purses, coolers or bags in Experimental Areas and Store Rooms?
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Check box if there is a repeated observation
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
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Check box if there is an issue(s) to report and/or report immediate.
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Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.
Additional comments and/or recommendations
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