Compliance in an Outsource Manufacturing Model: What to Look For - Pharmaceutical Technology

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PharmTech Europe

Compliance in an Outsource Manufacturing Model: What to Look For
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.

Pharmaceutical Technology


  • 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 or drugs?
  • 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

Laboratory samples

  • 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?


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