Sun pharma observation

SUN PHARMA 483 Observations for Halol Plant indicate serious GMP Issues.
•Compression Machines ( Point to Data Integrity Issue∗ )
•∗Compression machines are PLC controlled and can store data of events and alarm conditions which
occur during production. However the company does not document, review or evaluate alarm conditions or
events.
•Tablets are visually inspected for quality defects but there are no physical examples to visually
represent tablet defects.
•∗One of the qualifications of tableting process uses ‘X” number of tablet challenge articles.
However the company could not demonstrate that “x” number of challenge articles were used as challenge
articles were not available.
•Operation of compression machine requires performance checks to be conducted during the complete
process with action and alert limits for rejection. If the rejection is out of limits an investigation is
required to be performed. The rejected tablets are not evaluated for cause of rejection and unknown
contaminant. There is no data to support and provide scientific rationale for alert and action limits.