Audit information

  • Area Audited

  • Auditor Leader

  • Audit Team Members

Definition of ratings

  • 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

  • Does the personnel have professional education and training to perform the assigned tasks?

  • Is the personnel performingn as trained?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

Documentation

  • Have all records maintained in a secure and safe place?

  • Are all data and information entries indicated the date of entry in real time?

  • Are all data and information entries indicated by the person who made the entry?

  • Are data and information entered by Originator?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

Facilities

  • Is the area maintained in good housekeeping and kept in clean, neat, orderly and sanitary fashion?

  • Are offices and conference rooms free of chemicals, insecticides, and other materials?

  • Is the area free of food and beverages?

  • Is the area equipped and supplied with proper sanitary products?

  • Is the area equipped and supplied with proper GMP clothing?

  • Is the area free of plants, pets, and other living organisms?

  • Are visitors using appropriate PPE and GMP clothing according EHOS and GMP Standars?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • 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

  • Are all measurement devices and equipment calibrated, verified and qualified?

  • Are all equipment maintained to ensure it is operational condition as per requirements and intended use?

  • Has the equipment suffered unauthorized changes in the approved installation and configuration?

  • Is equipment operated by trained personnel on operation and use procedures?

  • Is equipment not be operated when is out of service or presenting evident malfunction?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

Use, cleanliness, status

  • Are equipment, glassware, utensils, etc. clean where materials and/or formula are handled?

  • Are materials provisioned correctly?

  • Are Pilot Plant equipment kept clean by user at the end of the work assignment, and equipment be showed status of use and cleanliness?

  • Are hoses not be left on floors when not in use and not be placed in drainage?

  • Are hoses not in use be dried and covered to avoid exposure to water, air and other sources of cross-contamination?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

Clothing

Laboratory clothing

  • Is personnel using indicated cloths as per GMP Working Standard in clean and neat conditions?

  • Are laboratory coats used in all lab areas?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

GMP clothing

  • Is hair net used when micro-sensitive materials and products are being handled?

  • Is Hair net used in Pilot Plants Facilities by everyone in the area?

  • Is Mouth cover used when micro-sensitive materials and products are being handled?

  • Is Mouth cover used by personnel with beard or long facial hair?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • 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.

  • Are the materials properly labeled or identified?

  • Is there a specific area for materials as per its status?

  • Are materials, formulas, and packaging materials covered to ensure their integrity? (except when handled for immediate use)

  • Are Materials and/or products not be placed on floors?

  • Are Expired materials located in the disposal area?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

Handling

  • Are Expired materials not be used and be located in the disposal area?

  • Are unattended, unlabeled and/or expired materials be transferred to disposal area?

  • Are all personnel handling wear clean gloves when opening containers of micro- sensitive products and raw materials?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

GMP Restrictions

  • Are not presences of food, drinks and chewing gum in Experimental Areas and Store Rooms?

  • Are not presence of personal belongings such as jackets, purses, coolers or bags in Experimental Areas and Store Rooms?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

EOHS

  • Do racks have indicated the maximum capacity?

  • Are there fire extinguishers in the area?

  • Do these signaling extinguishers visible?

  • Do people have knowledge of minimal safety behaviors?

  • Is it available personal protective equipment required handling raw materials and / or reagents present in the table?

  • Do you encounter the area in a safety condition?

  • Do people with long hair have it reflected in the work area?

  • Is there signaling required personal protective equipment?

  • Do staff is working in the same area with at least one companion?

  • Check box if there is a repeated observation

  • Indicate the number of item(s) or issue(s) has been repeated, and brief description of the issues(s) observed.

  • Check box if there is an issue(s) to report and/or report immediate.

  • 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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