Information

  • Document No.

  • Audit Title

  • Client / Site

  • Contact Person

  • Contact Phone Number

  • Fax Number

  • Conducted on

  • Prepared by

  • Location/Address
  • Personnel Accompanying Audit

  • Rating

    Green = 3
    Yellow = 2
    Orange = 1
    Red = 0
    N/A = Not Applicable

Part A - GENERAL INFORMATION

  • Administrative Contact/CEO:

  • Quality Contact:

  • Operation Contact:

  • Regulatory Contact:

  • R&D Contact:

  • Customer Service Contact:

  • Marketing Contact:

  • Additional Buildings: (Square Footage, Age, Operation, Number of Employees)

  • Type of Products or Services:

  • List of products or materials supplied to or considering being supplied to client and manufacturing site of each:

  • Approx. number of manufacturing employees:

  • Approx. number of packaging employees:

  • Approx. number of Quality Assurance employees:

  • Approx. number of Quality Control employees:

  • Approx. number of Regulatory employees:

  • Approx. number of R&D employees:

  • Approx. number of maintenance employees:

  • Approx. total number of employees:

  • Approx. annual sales:

  • Is the company:

  • Does the firm have product liability insurance?

  • If Yes, indicate the coverage amount:

  • Comments:

  • Supporting Photos

Part B - REGULATORY/QUALITY

  • Is the facility registered with the FDA under the Bioterrorism Act?

  • Are licenses/registrations up to date?

  • What is the date of the last FDA or other regulatory inspection?

  • Has the company ever been sued and are there any law suits pending?

  • Are there any regulatory actions pending against the company?

  • Is there a quality policy defined and supported by senior management?

  • Is there a quality manual or procedure describing the functions and responsibilities of the quality control unit?

  • Is the quality control unit independent from production operations?

  • Is the company certified by any recognized industry organization? Please indicate which ones:

  • Is there a written procedure requiring and describing international audits? If so, how often are these performed?

  • Is there a procedure for batch record reconciliation?

  • Is there a system or procedure for final product release?

  • Is there a program for qualifying suppliers?

  • Is there a program or are there procedures designed to ensure the safety of the products?

  • Are there procedures for the training of employees and does the training include GMPs?

  • Does the firm have a Material Review Board (MRB) for the purpose of reviewing and determining the disposition of OOS products or materials?

  • Is there a written procedure for handling customer complaints and AERs?

  • Does the Quality Control Unit review and/or investigate all customer complaints?

  • Are investigations for complaints completed in a timely manner and do they include identification of the root cause, disposition of the product or material, and corrective action to remedy problems in the future?

  • Is there a written procedure outlining the process for conducting a recall?

  • Does the company perform mock recalls to access the effectiveness of the recall procedure?

  • Comments:

  • Supporting Photos

PART C - ORGANIZATION AND PERSONNEL

  • Are there written job descriptions/specifications outlining the responsibilities and qualification requirements for each job position?

  • Does the firm have an organizational chart outlining the responsible positions for operations, QA/QC, R&D, and Regulatory personnel?

  • Do employees involved in operations, quality, and holding of products or materials have the education, training, or experience to enable to do their job.

  • Does the training SOP address both permanent and temporary employees?

  • Are there written procedures establishing employee health and hygiene requirements to protect the products from adulteration or contamination?

  • Are there written procedures describing the gowning requirements for controlled areas?

  • Comments:

  • Supporting Photos

PART D - PHYSICAL PLANT AND GROUNDS

  • Are there written procedures addressing the maintenance and sanitation of the facility internally and externally?

  • Does the firm have an employee assigned to supervise the sanitation program?

  • Is there a list of approved chemicals for cleaning the equipment and maintaining the sanitation of the facility?

  • Are cleaning and sanitizing agents stored in designated safe areas?

  • Is waste material handled appropriately?

  • Is there an effective pest control program in place?

  • Is the facility designed with sufficient space to allow for the smooth flow of materials and product and reduce the potential for mixups?

  • Is there adequate separation on production and packaging areas to prevent possible mixups?

  • Are the areas for manufacturing, packaging, and holding of product and materials environmentally controlled?

  • Does the facility have adequate lighting?

  • Does the water system used in the manufacturing process comply with Federal, State, and local requirements?

  • Is the water used for cleaning and hand washing safe, sanitary, at suitable temperature, and under continuous pressure?

  • Is the water sampled and tested to ensure that it meets written specifications, and does the firm issue a lot or tracking number to document its distribution in production?

  • Is the facility in a state of good repair?

  • Is the facility maintained in clean and sanitary conditions?

  • Are lockers provided to the employees for the storage of personal items?

  • Are employee restrooms adequate and readily accessible?

  • Is access to the facility restricted to employees and authorized personnel only?

  • Are controlled areas defined and access limited to authorized personnel?

  • Comments:

  • Supporting Photos

PART E - CHANGE CONTROL

  • Is there a formal written document change control program in place?

  • Is there a change control program for equipment, facilities, systems, utilities, etc?

  • Is there a written procedure for notifying customers of changes that may affect product quality?

  • Are changes through the change control program approved by the quality control unit?

  • Is there a system for retention and control of documents and records?

  • How long are records retained?

  • Is there a procedure for writing, approving, updating, and obsoleting SOPs?

  • How often are SOPs reviewed and/or updated?

  • Does the firm have a table of contents for Standard Operating Procedures?

  • Comments:

  • Supporting Photos

PART F - PRODUCTION OPERATIONS (MANUFACTURING, PACKAGING, AND LABELS)

  • Do the products manufactured or packaged have a distinctive and traceable lot number?

  • Does the firm have flow charts of the manufacturing and packaging process?

  • Are there written procedures for the handling of deviations and OOS test results?

  • Are there written established specifications for ingredients, components, in-process manufacturing, packaging, and finished product?

  • Are there written procedures that describe the preparation, review, approval, and revision of master manufacturing records?

  • Do master manufacturing records contain appropriate product information, processing instructions, specifications, etc?

  • Do the production batch records accurately follow the appropriate master manufacturing records?

  • Are there written procedures outlining the collection of retain samples of each lot of finished product?

  • Are there written procedures the refer to the rework or reprocessing of products that do not meet all established specifications?

  • Are there written procedures outlining the receipt, sampling, examination, release, and storage of labels?

  • Are there written procedures describing label control and label reconciliation?

  • Is there a program for cycle count and physical inventory of labels?

  • Comments:

  • Supporting Photos

PART G - EQUIPMENT, SYSTEMS, AND UTENSILS

  • Are equipment and utensils design and constructed for its intended use?

  • Is there a program for calibration of equipment/instruments?

  • Is there a program for determining equipment verification/validation?

  • Is there a program for determining process verification/validation?

  • Have procedures been established for the cleaning and sanitation of all utensils and equipment?

  • Is compressed air used in manufacturing treated to prevent contamination?

  • If compressed gas is used in the manufacturing or packaging process, is it controlled as a raw material, sampled, tested, released, and issued a lot number for distribution tracking?

  • Is all equipment identified with a distinctive ID and are there equipment records the document the cleaning/sanitation, inspection, use, and maintenance in chronological order?

  • Is there a written program for daily scale verification of calibration?

  • Does the firm have a preventative maintenance program for equipment?

  • Comments:

  • Supporting Photos

PART H - LABORATORY

  • Are all products tested in-house?

  • If outside laboratories are used for testing, have they been qualified according to a written program?

  • Can certificate of analysis be provided to your customers?

  • Does the firm conduct a minimum of ID testing on incoming raw materials and components?

  • Are analytical methods for testing available for review?

  • Do you have a procedure for handling laboratory waste?

  • Are there written procedures for the receipt, handling, storage, preparation, and use of all chemicals, standards, reagents, and solutions used in the laboratory

  • Are there written procedures for test methods?

  • Are test methods validated to include parameters such as accuracy, precision, linearity, robustness, and ruggedness?

  • Are test methods reviewed periodically to ensure their applicability to current standards?

  • Is there a master chemical inventory list?

  • Are standards, reagents, and solutions qualified prior to use?

  • Are MSDSs available for all chemicals used in the laboratory?

  • Is there a written procedure describing how numbers are to be rounded?

  • Is there a written procedure describing the issuance, control, and maintenance of laboratory lab books?

  • Is there a program for the calibration or certification of laboratory equipment/instruments?

  • Is there a written program for qualifying laboratory equipment/instruments (IQ/OQ)?

  • Is there a written procedure for handling failure investigations (OOS)?

  • Comments:

  • Supporting Photos

PART I - WAREHOUSE AND DISTRIBUTION

  • Are incoming trucks/trailers inspected for cleanliness and damage at time of receipt?

  • Does the facility have identified, separated, or defined areas for quarantine and rejected materials?

  • Are material control procedures in place for the receipt, sampling, testing, and release of raw materials, packaging components, and labels?

  • If refrigeration is used to store materials, is the temperature monitored by a device?

  • Is FIFO rotation practiced and outlined in a written procedure?

  • Are written procedures established regarding returned products?

  • Comments:

  • Supporting Photos

PART J - STABILITY

  • Is there a written procedure describing the sample size, test methods, test intervals, storage conditions, etc. for conducting stability testing?

  • Do stability results support the shelf life or expiration of the product?

  • Comments:

  • Supporting Photos

PART K - ELECTRONIC RECORDS AND COMPUTER SYSTEM

  • Is there a procedure for back-up and recovery of electronic data?

  • Is the electronic back-up data available and does the data contain exact and complete records of the data entered?

  • If applicable, does electronic documentation and electronic signatures meet the requirements of 21 CFR Part 11?

  • Comments:

  • Supporting Photos

PART L - CUSTOMER SERVICE/PERFORMANCE

  • Are products routinely delivered on time?

  • Have there been any products subject to return or recall since the last audit?

  • Have there been any complaints regarding products received by your customers?

  • Are responses to customer complaints handled in a timely manner?

  • Comments:

  • Supporting Photos

Final

  • Additional Comments:

  • Qualification standards can be measured by a point system or a percentage system. Companies may decide to use either or possibly both for final evaluation.´╗┐For the purposes of this audit, a percentage is given. Generally, the qualification standard by percentage is determined by the client requesting the audit. GMP Consulting Services requires a score of 90 percent for compliance qualification, however certain situations may be taken into account such as the severity of the findings or violation. In such cases, GMP Consulting Services requires a score of no less than 85 percent.

  • Signature of Auditor:

  • Signature of Company Representative:

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