Jointly Articulated by..
Dr Vanzyl and Dr Rahul Anand (Rajesh Hajela)
Contradictory Terms in use –
“Under Quarantine Release”
The term “Release” in pharmaceutical GMP refers specifically to the regulatory decision that a finished product (FG) is approved for distribution and patient use, after meeting all necessary quality criteria and official batch record review.
Under quarantine Transfer, or the movement of stock between controlled warehouses is sometimes called a “Under Quarantine release,” but this is misleading.
Such stock movement is not a true release; it is a permitted transfer of goods under the control of the final releasing authority, and the medicine remains under quarantine until fully approved for patient use.
True Meaning of “Release”
• Final release means a batch has met all regulatory and quality requirements and is authorized for marketing and patient consumption.
• The decision is made by a Qualified Person (EU) or authorized QA/QC professional (US/EU/FDA), who certifies the batch based on testing and review.
• Release must not be confused with internal operations such as warehouse transfers or logistical stock movements while goods remain under quarantine.
Quarantine Stock Transfers
• Movement of products between warehouses under quarantine is an internal transfer between warehouse inside or may be outside the factory premises including client warehouse and not an actual release.
• Such transfers maintain the batch under the control of the final release authority; the product is not available for sale or patient administration.
• In regulatory terms, the status remains “Quarantined” and traceable until official batch release.
The key is the quarantine control on all warehouses between which this transfer is Happening.
Parametric Release
Parametric release is entirely different term and must not be confused and used as tool for releasing something with pending tests.
• It permits the marketing of a batch by omitting certain end-product tests and not just keeping it pending, provided all in-process monitoring and control parameters demonstrate compliance (e.g., sterility test for terminally sterilised products).
• The rationale and controls for parametric release must be scientifically justified and approved by regulatory authorities; it is never to be confused with simple stock movement under quarantine.
Key Points
• Use “release” only to mean approval for patient use/marketing.
• Quarantine stock movement is not release; approval status does not change.- This is permitted between controlled warehouse to controlled warehouse movement to save transit time.
• Parametric release signifies omission of a test based on acceptable process/risk-based scientific rationale.
This use of precise terminology ensures regulatory compliance and protects patient safety, aligning with PIC/S, EU, and USFDA GMP/GDP guidelines
Dr A J Vanzyl
Dr Rahul Anand
For Success Samikaran
– GMP Series
Rahul's space 