U.S. FDA Flags Nine Lapses At Panacea Biotech’s Baddi Facility

The U.S. drug regulator has flagged nine procedural lapses at Panacea Biotech Ltd.'s sterile and non-sterile manufacturing facility in Baddi, Himachal Pradesh.

"The U.S. Food and Drug Administration conducted an inspection of the company's material wholly owned subsidiary, Panacea Biotec Pharma Ltd., at Baddi, Himachal Pradesh, India, between Oct. 3 and Oct. 12," the company said in an earlier exchange filing on Oct. 12.

At the end of the inspection, Panacea Biotec Pharma was issued a Form 483 with nine observations "which are related to improvements in existing procedures and are addressable," the company said.

A Form 483 is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act and Related Acts.

The company said that it will respond to the U.S. FDA within the stipulated time and work closely with them to close the said observations.

BQ Prime has obtained a copy of the observations from the administrator.

These are the observations that were made:

1. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Seven specific discrepancies were noted during the review of aseptic practises. Also, the qualification of aseptic personnel was noted to be deficient, as it did not specify activities to be performed during a media fill to be qualified.

2. Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Two instances were identified where adequate scientific justification could not be provided for the deficiency and the gowning specifications of personnel were not appropriate.

3. The visual inspection process used to reject critical and major defects in drug products is inadequate. Five issues were noted regarding the kits used for inspection, qualification of visual inspectors, etc.

4. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. There were issues noted with smoke studies, media fills, restricted access barrier (RAB) interventions, and validation protocols; only a summary of interventions was maintained, not specific details regarding the number and type of interventions occurring for each batch.

5. Failure to thoroughly review any unexplained discrepancy and failure of any batch or components to meet specifications Noted non-viable machine excursions were not investigated due to the updating of procedures.

6. Procedures for cleaning and maintenance are deficient with regards to methods, procedures and equipment to be used. Cleaning procedures for cleaning of RAB and aseptic area did not contain enough detail to ensure reproducibility between operators. Four issues were identified.

7. Laboratory controls did not include the establishment of scientifically sound and appropriate standards, specifications and test procedures designed to assure that components and products conform to appropriate standards of quality and purity. Six instances were highlighted.

8. Responsibilities and procedures applicable to the quality control unit are not in writing and are not fully followed. Quality oversight is inadequate in aseptic viewing areas.

9. Equipment used in manufacture, processing and packing is not of appropriate design and suitable location to facilitate operations for intended use and for cleaning and maintenance.

Queries regarding the impact of the observation on revenues and the time period of resolution sent to the company remain unanswered at the time of publication.

Shares of Panacea Biotech were trading 4.55% lower at Rs 158.30 apiece at 1:04 p.m., compared with a 0.37% fall in the benchmark Sensex on Friday.