- Are all critical support systems (e.g., water for injection, nitrogen, clean compressed air, clean steam, equipment cleaning,
vial washing, closure processing) validated?
- Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned, ready for service"?
- Is idle equipment stored in a designated area?
- Are there operational SOPs for instruments?
- Are written procedures available for each piece of equipment used in the testing or holding of components, in-process material
- Are all pieces of equipment clearly identified with easily visible markings?
- Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log?
- Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance?
- Is there a maintenance log for each piece of equipment?
- Are there use logs for all analytical equipment?
- Are written procedures established for the cleaning and maintenance of equipment and utensils (e.g., autoclave, oven, tanks)?
- Has a written schedule been established and is it followed for equipment cleaning?
- Are written records maintained on equipment cleaning, sanitizing, and maintenance on or near each piece of equipment?
- Does the facility have approved written procedures for checking and calibrating each piece of measurement equipment?
- Is all instrumentation installed and qualified (installation qualification, operational qualification, and performance qualification,
IQ/OQ/PQ) with supporting documentation?
- Is there a program for qualifying equipment? Have all appropriate pieces of equipment been validated?
- When computers are used to automate production or quality testing, have the computer and software been validated?
Organized sample storage, material and component control
- Are samples collected and identified properly and according to SOPs?
- Is the receipt, storage, handling, inventorying and disposing of samples adequately tracked?
- Is chain-of-custody maintained?
- Does the laboratory have the facility and controls to ensure proper storage of samples under appropriate conditions (e.g.,
refrigeration) from the time of receipt to disposition?
- Is there a procedure for reserve and retention samples?
- Is this procedure followed?
Laboratory chemicals, solutions, and reagents
- Are all containers identified?
- Is there an expiration or retest date on each container based on manufacturer information or stability data?
- Do standardized volumetric solutions, reagents, and solutions have reference to notebook on preparation?
Standards, testing, and methods
- Are standard solutions and reagents properly handled?
- Is there adequate expression and recording of laboratory measurements (e.g., procedures for data rounding and averaging)?
- Is there proper handling, qualification, and requalification of reference standards?
- Is there testing and monitoring of process water (e.g., water for injection as well as deionized and USP water)?
- Is there adequate handling of modifications to analytical methods?
- Are there procedures for the formalization of analytical methods?
- Are there procedures for interlaboratory methods transfer and qualification?
- Are there procedures for resampling, retesting, and rechromatography?