Van Zyl GMP International. Dr AJ van Zyl

Van Zyl GMP International. Dr AJ van Zyl Dr AJ van Zyl: WHO: Panel of Experts. Offers GMP, GCP, GLP audits and training Auditing, inspecting and consulting. Gap analysis. Training. Monitoring (GCP).
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All aspects of GMP (APis and FPPs), GCP and GLP in clinical trials and bio-equivalence studies
HVAC, Validation and more...

Dabur.FDA Warning Letter: On-Site Discovery of Record Falsification During Inspection
10/08/2026

Dabur.
FDA Warning Letter: On-Site Discovery of Record Falsification During Inspection

The U.S.

04/08/2026
28/07/2026
BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE IN...
28/07/2026

BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION

This Strides site received a 17 page FDA483 with observations relating to problems identified.Summarized as follows:1. P...
25/07/2026

This Strides site received a 17 page FDA483 with observations relating to problems identified.

Summarized as follows:
1. Problems with microbiological testing including lack of validation of the method used;
2. Loss of electronic audit trail in manufacturing equipment;
3. Risk of cross- contamination due to residue on equipment and HEPA filter housing after cleaning;
4. Obsolete and unauthorized recipes on equipment as well as inadequate access and user privilege management;
5. Incomplete testing against specifications.

See full 483 for details

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George South

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