Accuracy

Following the series of ALCOA+ publications, it is time to review last concept of classical ALCOA: Accuracy Data.

A way to guarantee the accuracy of all data and records is to ensure that they are: complete, free of errors, reflective to the observation of any data and, in some cases, subject to a double check due to the criticality of data collection or transfer.

If the management of the data is done through an electronic system there is a need to place accuracy checkers. It is also required to place controls that verify that no compulsory data is left empty. Lastly, the system may ensure that any modification made on the recorded data is documented and all amendments are annotated.

To further illustrate the Accuracy concept let’s look at two FDA warning letter:

Warning Letter 320-20-15 (December 23, 2019)

 Your firm contract manufactures over-the-counter (OTC) drug products, some of which are labeled to be used for children. During a review of an out-of-specification (OOS) investigation for (b)(4) content in your bulk (b)(4) lot (b)(4), our investigator identified multiple discrepancies between the human machine interface (HMI) data, and the entries made by operators into batch records. For example, the operator recorded (b)(4) the batch during Step (b)(4) for (b)(4) at (b)(4). However, HMI data indicated that (b)(4) were not operational at that time.

(…)

Your quality system does not adequately ensure the accuracy and integrity of the data to support the safety, effectiveness and quality of the drugs you manufacture. Without complete and accurate records, you cannot assure appropriate decisions regarding batch release, product stability, and other matters that are fundamental to ongoing assurance of quality.

 

 

Warning Letter 320-19-14 (March, 2019)

 Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).

Your microbiology laboratory did not accurately report test results. On March 27, 2018, during a walk-through of your laboratory, our investigator observed microbial growth on (b)(4) personnel/environmental monitoring media plates associated with (b)(4) aseptic processing lines. However, our review of laboratory records found that analysts had recorded a result of “Nil” (no growth) for each of these plates. On the same day, our investigator also observed that your microbiologist had significantly underreported microbial results for three (b)(4) samples.

During the inspection, your staff confirmed that laboratory records did not accurately reflect the actual microbial growth observed on plates.

Accurate microbiological data is fundamental to evaluating and maintaining the state of control of an aseptic processing operation. Awareness of microbial excursions in an aseptic processing operation is essential to trigger prompt actions that maintain environment control. Your failure to report accurate data compromised the sterility assurance of drug products released from the facility and may have increased risks to patients.

One of the actions the FDA requested as a main solution is:

A comprehensive, retrospective review of reliability of all microbiology laboratory data, including but not limited to data relating to water system control and environmental monitoring (personnel, surfaces, air). Assess all batches within expiry and distributed in the United States.

So, how does SherpaPharma ensure data accuracy? The following underlined aspects of the system are the way we ensure accuracy:

  • The system has been designed to fully comply with Regulatory requirements described both in cGMP Annex 11 and in CFR Part 11.
  • Each new version is fully validated following GAMP5 steps for a system classified as Level 4.
  • Some critical information has been defined as compulsory and it must be filled-in in order to continue with the process.
  • All data entered are signed and time stamped.
  • Any data introduced with the hand device are automatically and instantaneously transferred to the data base and cannot be modified.
  • SherpaPharma can be connected with ERP systems to automatically transfer all batches that have been manufacture so the environmental monitoring activities can be associated to them.
  • SherpaPharma can be also connected with other lab equipment to transfer analytical information (equipment used, colony identification…) avoiding human error.

 

  • All reports include the number of samples that were deleted and the number of samples that had a modification in their results after being introduced.