Violation of good manufacturing practices by sterile injectables unit of Alembic Pharma identified by USFDA
At the beginning of February 2021, the US drug regulator issued “Form 483” to the Kharkhadi unit of Alembic Pharma. This is a sterile injectables manufacturing unit of the drug firm that is situated in Gujarat.
The form was issued after the unit was inspected by the USFDA inspectors. These inspectors revealed that the unit violated the good manufacturing practices that must be observed during production. The violations were related to quality control, cleanliness and size of the equipment, and inadequate sample collection procedures at the site.
The US drug regulator has also reported that the quality control department of this unit “lacked the authority to investigate the errors that have occurred”. It further added that the company’s investigation on this matter was inadequate. This inadequacy was attributed to the fact that the company failed to address the testing of toxins in a particular batch of products.
GMP Violation: What was the matter?
The company’s aseptic area was also deficient, and one of the GMP violation norms also mentions this. This difficulty in environmental monitoring increased the chances of product contamination in the unit. Other violations include the deficient procedures for the operation of the equipment in the unit. It stated that over 15 recorded failures were observed on a testing machine in one of the facility’s manufacturing lines. Apart from this, the equipment used in the manufacturing, processing, and packaging of drug products was also not of appropriate design or size. Furthermore, these were also not situated in suitable locations in the facility.
In response to these claims, the drug firm has announced that these observations were unrelated to the data integrity and only “procedural in nature”.
USFDA has issued 15 working days for the company to respond with a corrective and preparative action plan. This plan, if satisfactory, could pave the way for the clearance of the facility by the USFDA.
This manufacturing unit of Alembic Pharma in Gujarat is pivotal for the company as it caters to the international markets. Both US and Europe receive products that are manufactured in this unit.
- 1. United States Food and Drug Administration
- 2. United States