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Warning Letter: CP Pharmaceuticals (Wockhardt Limited)

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, CP Pharmaceuticals, Ash Road North, Wrexham Industrial Estate, Wrexham, United Kingdom, from October 5 to 9 and October 12 to 13, 2015.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

 

We reviewed your firm’s November 3, 2015, response in detail and acknowledge receipt of your subsequent responses.

 

Our investigator observed specific violations during the inspection, including, but not limited to, the following.

 

1.  Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. (21 CFR 211.113(b))

 

Our investigator observed poor practices during aseptic set-up and filling, including but not limited to the following examples.

  • Multiple operators who had touched surfaces and items in the ISO-7 clean area failed to disinfect their hands before performing activities within the ISO-5 area.   For instance, we observed operators touching the external control panel and push carts. Without disinfecting their gloved hands, these operators then opened the Restricted Access Barrier System (RABS) and performed activities in the ISO-5 area.
  • We observed operators moving briskly and causing excessive movement of the (b)(4) located immediately adjacent to the RABS. This excessive movement occurred while the RABS (b)(4) were open.
  • You do not routinely disinfect the cart used for holding (b)(4) items prior to use. This cart is stored in the Grade B area for an extended period, and is cleaned and disinfected only (b)(4).
  • We observed (b)(4) bags with sterile supplies coming in contact with the (b)(4) in the ISO-7 area when being transported to the RABS. These bags were not disinfected prior to entry into the RABS. 

These deviations were neither documented in your batch production record, nor captured by the quality unit during their observation of videos of the operation as per your SOP #QAP-199-0-1704. This procedure requires quality unit personnel to review the acceptability of general techniques and behaviors of cleanroom personnel within classified areas (ISO 5 and ISO 7).   

 

The ISO 5 is a critical area because sterile product is exposed and therefore vulnerable to contamination. Your aseptic filling process should be designed, and operations executed, to prevent contamination hazards to your sterile product.

 

Your firm’s response is inadequate. Although your response includes a revised procedure (QAP-199-0-1704) on quality oversight of operations, you did not retrospectively evaluate video footage to identify poor aseptic practices and identify any batches produced under these conditions. In response to this letter, provide a third party’s independent assessment of aseptic processing practices and affected batches.   

 

2.   Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. (21 CFR 211.42(c)(10))

 

a.  Environmental Monitoring

Your environmental monitoring program did not sufficiently cover personnel in your ISO-5 area during set-up, filling,

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