Four Things You Need to Know About FDA's Guidance for Tissue Establishments

FDA Reminds Manufacturers About Their GTP Responsibilities

After the FDA shut down two tissue-recovery firms last year because of serious Good Tissue Practice (GTP) violations, the agency issued a guidance that essentially reminded the industry to comply with the regulation.

The guidance emphasized that when manufacturers hire contractors to perform any step in the manufacturing process, such as tissue recovery, the manufacturer must ensure that the contractor complies with GTP requirements.

The guidance came after the FDA ordered Donor Referral Services (DRS) of Raleigh, N.C., and Biomedical Tissue Services (BTS) of Fort Lee, N.J., to cease all manufacturing operations. DRS had serious manufacturing deficiencies in the areas of donor screening and record keeping. BTS also had donor-screening and record-keeping violations, and it failed to follow its own SOPs.

In light of this, let's revisit the ?Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) ? Manufacturing Arrangements,? issued in September 2006. Here are the highlights of the guidance:

1. Make Sure Your Contractors Are Compliant. It is the manufacturer's responsibility to ensure that any contractors performing any manufacturing step are compliant with applicable GTP requirements. The FDA will evaluate a manufacturer's efforts to ensure that contractors are GTP compliant during inspections.

2. Contractors are Subject to Applicable Regulations. The manufacturer does not have to validate the processes of its contractor (e.g., a firm that performs terminal sterilization such as irradiation on HCT/Ps for a processor) because the contractor itself is subject to 21 CFR Part 1271. It goes without saying, however, that the manufacturer should choose only contractors that validate their processes and comply with other GTP requirements.

3. Perform Due Diligence. This guidance suggests several ways to conduct due diligence, including:

  • Initial audit
  • Review of test kit package inserts
  • Test the laboratory's SOPs
  • Review the contractor's compliance history
4. Take Appropriate Action. The FDA expects manufacturers to continuously monitor their contractors for compliance. It is not enough to conduct an initial audit. To this effect, the agency puts the burden on the manufacturer to ?take appropriate action? if there is any indication that the contractor is noncompliant.

Read about GTP and GMP compliance:

FDA Link

  • Guidance for Tissue Establishments

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