Specialty Process Labs LLC is a specialty API manufacturer of natural desiccated thyroid. Which is, yes, what you might think it is. And as far I can tell, mostly ships direct to compounding pharmacies and patients. This month they got a warning letter.
The warning letter highlights:
- Failure to validate the process
- Failure to test to specification
- Failure to exercise sufficient controls over computerized systems
All three of these observations make me rather glad my loved-ones take levothyroxine and I am deeply aware of all the difficulties in that drug supply.
Focusing more on the computer system, it is an unsurprising list of bad access controls, change controls not controlled, and failure to validate excel spreadsheets.
The last observation really stood out to me:
“Manufacturing master batch records held in electronic form on your company’s shared drive do not have restrictions on user access. Your quality unit personnel stated that there are no restrictions for any personnel with login credentials to access new and obsolete master records. Our investigator observed during the inspection multiple versions of batch records were utilized for API lot production.”
This is truly a failure in document access and record management. And it is one I see a lot of places. The core requirement here is really well stated in the PIC/S Data Integrity Guidance requirement 8.4 “Expectations for the generation, distribution and control of records.” Please read the whole section, but pay close attention to the following:
- Documents should be stored in a manner which ensures appropriate version control.
- Master documents should contain distinctive marking so to distinguish the master from a copy, e.g. use of coloured papers or inks so as to prevent inadvertent use.
- Master documents (in electronic form) should be prevented from unauthorised or inadvertent changes.
- Document issuance should be controlled by written procedures that include the following controls:
- details of who issued the copies and when they were issued; clear means of differentiating approved copies of documents, e.g. by use of a secure stamp, or paper colour code not available in the working areas or another appropriate system;
- ensuring that only the current approved version is available for use;
- allocating a unique identifier to each blank document issued and recording the issue of each document in a register; – numbering every distributed copy (e.g.: copy 2 of 2) and sequential numbering of issued pages in bound books;
- where the re-issue of additional copies of the blank template is necessary, a controlled process regarding re-issue should be followed with all distributed copies maintained and a justification and approval for the need of an extra copy recorded, e.g.: “the original template record was damaged”;
- critical GMP/GDP blank forms (e.g.: worksheets, laboratory notebooks, batch records, control records) should be reconciled following use to ensure the accuracy and completeness of records; and
- where copies of documents other than records, (e.g. procedures), are printed for reference only, reconciliation may not be required, providing the documents are time-stamped on generation, and their short-term validity marked on the document
There are incredibly clear guidelines for these activities that the agencies have provided. Just need to use them.
Investigations of a Dog 