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.
SO - Systematic observation, significant number issues or deviation to the policy were observed.
AI - Administrative Issue, observations suggests lack of attention to the policy, intentional deviation to the policy.
LS - Lack of System, missing SOP, engineering solution required, budge may be required.
Total rating of GMP Audit
Personnel Qualification
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Does the personnel have professional education and training to perform the assigned tasks?
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Is the personnel performingn as trained?
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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.
Documentation
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Have all records maintained in a secure and safe place?
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Are all data and information entries indicated the date of entry in real time?
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Are all data and information entries indicated by the person who made the entry?
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Are data and information entered by Originator?
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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.
Facilities
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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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Is the area equipped and supplied with proper GMP clothing?
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Is the area free of plants, pets, and other living organisms?
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Are visitors using appropriate PPE and GMP clothing according EHOS and GMP Standars?
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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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Has the equipment suffered unauthorized changes in the approved installation and configuration?
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Is equipment operated by trained personnel on operation and use procedures?
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Is equipment not be operated when is out of service or presenting evident malfunction?
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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 materials provisioned correctly?
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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.
Clothing
Laboratory clothing
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Is personnel using indicated cloths as per GMP Working Standard in clean and neat conditions?
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Are laboratory coats used in all lab areas?
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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 clothing
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Is hair net used when micro-sensitive materials and products are being handled?
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Is Hair net used in Pilot Plants Facilities by everyone in the area?
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Is Mouth cover used when micro-sensitive materials and products are being handled?
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Is Mouth cover used by personnel with beard or long facial hair?
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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?
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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 Materials and/or products not be placed on floors?<br>
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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.
EOHS
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Do racks have indicated the maximum capacity?
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Are there fire extinguishers in the area?<br>
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Do these signaling extinguishers visible?
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Do people have knowledge of minimal safety behaviors?
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Is it available personal protective equipment required handling raw materials and / or reagents present in the table?<br>
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Do you encounter the area in a safety condition?
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Do people with long hair have it reflected in the work area?<br>
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Is there signaling required personal protective equipment?<br>
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Do staff is working in the same area with at least one companion?<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.
Additional comments and/or recommendations
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