Collecting, analyzing, reporting, and presenting operational metrics related to the QC laboratory (e.g. right-first-time on testing, testing turnaround times, testing backlogs, etc.)?
2.4.3.13
Managing regulatory agency inspections?
2.4.3.14
Managing internal and external audits?
2.4.4
Does the administrator, office manager, or similar support person perform or supervise keeping current with FDA and regulatory related items such as:
FDA has several e-mails feeds to which you can subscribe, including notification of Warning Letters, Guidance Document updates, etc. through the Subscription Management Center: https://www.fda.gov/about-fda/contact-fda/get-email-updates You will receive automatic e-mail notifications to the topics with which you wish to stay current.
Keeping current with the USP/NF, BP, JP, EP, etc.?
Organizations are encouraged to purchase online subscriptions to the USP/NF and other pharmacopeia as appropriate.
2.4.4.6
Keeping current with industry groups such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Parenteral Drug Association (PDA), etc.?
2.4.5
Does the administrator, office manager, or similar support person perform or supervise keeping current with industry trends by monitoring or subscribing to:
Does the administrator, office manager, or similar support person supervise administrative service personnel such as maintenance and calibration, laboratory computers, documentation section, training section, etc.?
2.5
Laboratory Chemicals, Solutions, Reagents, and Supplies
2.5.1
Is there a written procedure for receipt and storage of chemicals and reagents?
2.5.2
Are chemicals and reagents properly labeled with date of receipt, date opened, and expiration and re-test dates?
2.5.3
Are laboratory prepared reagents and solutions properly identified (e.g. chemical name or symbol, concentration, date of preparation, initials of the analyst who prepared it, and expiration date)?
Unlabeled solutions are an FDA form 483 favorite citation.
2.5.4
Are records available which document preparation and standardization of volumetric solutions?
2.5.5
Is the frequency of standardization of various reagents described? Is it consistent with the current USP?
2.5.6
Are standardized reagents properly stored to assure integrity?
2.5.7
Does a procedure exist, which describes the generation/purchase, storage, and handling of reagent grade water for laboratory use?
Laboratory water, when opened (exposed to air) will start to grow microbes almost immediately. Therefore, experience has shown that lab water should not be held for greater that 24 hours. If the water is used to prepare chromatographic samples, extraneous peaks resulting from the microbial contamination are possible. This means that water stored in squirt bottles needs to be changed daily.
2.5.8
Are there procedures that describe the preparation of laboratory reagents and cultures?
2.5.9
Are there procedures that describe the maintenance of laboratory reagents and cultures?
2.6
Laboratory Reference Standards and Solutions
2.6.1
Is there a written procedure for ordering and receipt of compendial reference standards and non-compendial reference standards?
investigations, equipment issues, etc.)?
