18/19 June 2024
Serious violations of Good Manufacturing Practice in the manufacture of sterile products have been observed during a FDA inspection at the Indian manufacturer Emcure Pharmaceuticals Limited between January, 27th and February, 4th 2015. Warning Letters from the FDA always refer to the respective paragraphs from 21 CFR Part 211. The 7-page Warning Letter addressed to the Indian company focussed on major deviations with regard to 21 CFR 211.113(b), 21 CFR 211.160(b) and to 21 CFR 211.194(a).
The first part of this News closely examines the deficiencies regarding 21 CFR 211.113(b).
"Your firm failed to establish and 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))"
Here, the deficiencies are divided into 3 groups:
Poor Aseptic Processing Practices:
On the inspector's part, a number of negative observations have been listed:
In addition, it has been noticed that all these elements had been regulated but not executed by the staff.
Poor Sterilization Practices:
The validation report referred to a loading pattern for the RABS. According to the inspector's observation, the operators didn't follow it.
Two aspects have been primarily criticised by the inspector. An employee crawled under a filling line to access an area where he performed other critical operations. Besides, the inspector wasn't delighted by the point regarding collected water from the bottom of a filling machine to lubricate equipment!
When answering to the inspection report (with regard to the deficiencies list on the Form 483), the FDA would have expected an evaluation of all available videos to identify all batches that could be affected by poor aseptic practices and associated risks. As response to this Warning Letter, the FDA now expects following actions to be taken by the company:
The coming part 2 will be dedicated to the deficiencies with regard to environmental and personnel monitoring.
Source: FDA Warning Letter dated 03.03.2016 for Encure Pharmaceutical Limited