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Information
Document No.
Audit Title
Client / Site
Conducted on
Prepared by
Location
Personnel
Facility Address:
Approximate square footage of facility:
Year building was built:
Years in business:
Number of employees, Full Time/Part Time:
Key Contact/Title:
Rating
Green = 3 Yellow = 2 Orange = 1 Red = 0 N/A = Not Applicable
1.0 Administration
Are licenses and registrations current?
Does firm have liability insurance?
Can the firm provide an index of current Standard Operating Procedures?
Is there a document retention procedure?
Is there a quality manual?
Comments:
Supporting Photos
2.0 Organization and Personnel
Does the firm have an organizational chart?
Does the firm have adequate staffing to meet demands?
Are personnel qualified by education, training, and/or experience?
Are CVs available for key personnel?
Are there written job descriptions outlining responsibilities for each position?
Does the staff possess the experience in testing the samples generated from contract manufacturing?
Comments:
Supporting Photos
3.0 Training
Are there written procedures for training lab technicians on instruments and test methods?
Is there documentation of training on procedures, test methods, and laboratory equipments?
Are training records readily available?
Are training records current?
Does the firm have a documented safety program which includes documentation of safety training prior to allowing employees to perform laboratory tasks?
Comments:
Supporting Photos
4.0 Receipt of Test Sample
Are there written procedures on receipt of test samples?
Are samples adequately identified upon receipt?
Are samples handled in a way to avoid mix-ups?
Comments:
Supporting Photos
5.0 Facility and Sanitation
Is the laboratory in a controlled environment?
Are humidity and temperature monitored via recording devices?
Is there adequate laboratory space for testing without the possibility of mix-ups?
Is the laboratory maintained in a clean and sanitary condition?
Is the layout of the laboratory designed to prevent cross contamination?
Is hazardous waste disposed of properly and are there written procedures describing the method of disposal.
Comments:
Supporting Photos
6.0 Change Control
Does the firm have a formal written change control program?
Is change control being followed for written procedures and test methods?
Comments:
Supporting Photos
7.0 Method Validation/Verification
Are there written procedures for test methods?
Are test methods based on compendium methods from USP, EP, JP, FCC, AOAC, etc?
Are compendium methods verified or validated internally to ensure uniform consistency?
Does the method validation include adequate reference to parameters such as accuracy, precision, linearity, robustness, ruggedness, etc?
Are test methods reviewed periodically to ensure their applicability to current compendium standards?
Comments:
Supporting Photos
8.0 Solutions, Standards, and Reagents
Are there written procedures outlining the receipt, handling, storage, preparation, and use of all chemicals, standards, reagents, and solutions in the laboratory?
Is the storage of primary standards, secondary standards, solutions, and reagents suitable to protect the integrity of each?
Are standards, solutions, and reagents qualified prior to use and is the qualification documented?
Are in-house test solutions given a unique identification code that allows for full traceability?
Is the preparation of test solutions documented in a laboratory notebook?
Is there a master chemical inventory list?
Do containers have labels that indicate the date received, date opened, and expiration date?
Are there written procedures used to determine expiration dating?
Are expired containers of standards, solutions, and reagents removed from the laboratory to prevent use?
Are MSDS available to employees for all chemicals on the premises?
Comments:
Supporting Photos
9.0 Analytical Testing
Is there a written procedure describing to rounding of numbers?
Is there a written procedure for the issuance, maintenance, and control of laboratory notebooks?
Do test results demonstrate analysts are following the proper procedures?
Are data and calculations reviewed, verified, and documented as such by a second person?
Are notebooks and hand written documentation maintained properly and in accordance with cGLPs?
Is there a written procedure for notifying the customer in a timely manner regarding quality related issues with the received samples or OOS test results?
Comments:
Supporting Photos
10.0 Calibration, Maintenance, and Qualification
Is an equipment list available?
Are there sufficient backup instruments to test contract samples in the event of system down-times?
Is there a written program for the calibration of equipment and instruments?
Are calibration logs maintained and do they include information required by written procedures?
Are calibration standards traceable to NIST standards?
Do written procedures for calibration include the frequency for calibrations?
Does the condition of laboratory equipment indicate that they are well maintained?
Are there written procedures that include the qualification of laboratory equipment (IQ, OQ, PQ)?
Are laboratory instrument computers and software validated? If electronic records are used, do they meet compliance to 21 CFR 11?
Comments:
Supporting Photos
11.0 Failure Investigation
Is there a written procedure on handling OOS investigations?
Does the failure investigation procedure include the communication requirements with the client?
Does the procedure provide guidelines for replicate testing, standards useage, instrumentation calibration, chromatographic data review, data rejection, and documentation?
Are adequate records maintained with respect to the failure investigations?
If retesting is performed in accordance with OOS procedures, is the method based on sound statistical data?
Do all investigations conclude an actual or probable cause for the failure?
Comments:
Supporting Photos
12.0 Self Audits and Inspections
Has the FDA or other regulatory agencies inspected the facility and if so what were their observations? Please provide 483s or observation reports.
Are responses to audits in the form of corrective and preventative action reports?
Are corrective actions being implemented within a reasonable timeframe?
Is there a written procedure for conducting internal audits?
Are internal audits being conducted according to the written procedure, and does the procedure state a frequency for such audits?
Comments:
Supporting Photos
13.0 Result Reporting
Is the laboratory capable of reporting reviewed and approved test results in an expedited manner?
Do the report headers contain necessary information such as company letterhead, client contact information, PO number, sample lot number, date received, etc?
Do the bodies of the reports contain specifications, results, method references, and notebook references?
Do the test reports have the proper signatures for review and approval?
If delivered electronically, are the reports formatted in a protected system that prevents alterations?
Are data packets submitted with the final reports and are they in indelible ink?
Comments:
Supporting Photos
Professional Affiliations/Programs
Has the laboratory participated in any proficiency programs?
How did the laboratory rate in the proficiency programs?
Does the firm have a list of publications available?
Has the laboratory participated in any AOAC programs such as single lab validation so, expert review panels, collaborative studies, as study director, advisor, or committee member?
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.
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